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. 2016 Jan 15;2016:1902.

Venous leg ulcers

E Andrea Nelson 1,#, Una Adderley 2,#
PMCID: PMC4714578  PMID: 26771825

Abstract

Introduction

Leg ulcers usually occur secondary to venous reflux or obstruction, but 20% of people with leg ulcers have arterial disease, with or without venous disorders. Between 1.5 and 3.0 in 1000 people have active leg ulcers. Prevalence increases with age to about 20 in 1000 people aged over 80 years.

Methods and outcomes

We conducted a systematic overview, aiming to answer the following clinical questions: What are the effects of treatments for venous leg ulcers? What are the effects of organisational interventions for venous leg ulcers? What are the effects of advice about self-help interventions in people receiving usual care for venous leg ulcers? What are the effects of interventions to prevent recurrence of venous leg ulcers? We searched: Medline, Embase, The Cochrane Library, and other important databases up to March 2014 (BMJ Clinical Evidence overviews are updated periodically; please check our website for the most up-to-date version of this overview).

Results

At this update, searching of electronic databases retrieved 116 studies. After deduplication and removal of conference abstracts, 63 records were screened for inclusion in the overview. Appraisal of titles and abstracts led to the exclusion of 43 studies and the further review of 20 full publications. Of the 20 full articles evaluated, four systematic reviews were updated and four RCTs were added at this update. We performed a GRADE evaluation for 23 PICO combinations.

Conclusions

In this systematic overview, we categorised the efficacy for 13 interventions based on information about the effectiveness and safety of advice to elevate leg, advice to keep leg active, compression stockings for prevention of recurrence, compression bandages and stockings to treat venous leg ulcers, laser treatment (low level), leg ulcer clinics, pentoxifylline, skin grafting, superficial vein surgery for prevention of recurrence, superficial vein surgery to treat venous leg ulcers, therapeutic ultrasound, and topical negative pressure.

Key Points

Leg ulcers are usually secondary to venous reflux or obstruction, but 20% of people with leg ulcers have arterial disease, with or without venous disorders.

The last version of this overview on treatment and prevention of venous leg ulcers included a range of interventions.

This updated overview focuses on interventions selected because they are the most likely to be available in current clinical practice.

We have searched for evidence from RCTs and systematic reviews of RCTs on the effectiveness and safety of these treatments in people with venous leg ulcers — some of whom had concurrent diabetes mellitus or rheumatoid arthritis.

Compression (bandages and stockings) heals more ulcers compared with no compression, but we don't know which compression technique is most effective.

  • Compression is used for people with ulcers caused by venous disease who have an adequate arterial supply to the foot.

  • The effectiveness of compression bandages depends on the skill of the person applying them.

Oral pentoxifylline increases ulcer healing in people receiving compression.

We don't know whether therapeutic ultrasound, superficial vein surgery, skin grafting, leg ulcer clinics, laser treatment, or advice to elevate legs or increase activity increase healing of ulcers in people treated with compression.

Compression bandages and stockings reduce recurrence of ulcers compared with no compression, and should ideally be worn for life.

Superficial vein surgery may also reduce recurrence.

Clinical context

General background

Venous leg ulceration occurs secondary to venous reflux or obstruction. It affects up to 3 in 1000 people, and is more common in older people. Venous leg ulceration has a negative impact on quality of life and results in considerable costs to both patients and healthcare providers.

Focus of the review

The aim of this overview is to update the research evidence for the management of venous leg ulceration. This update focuses on evidence for interventions that are likely to be available in current clinical practice. Dressings and larvae therapy are excluded from this overview because systematic reviews have not identified any robust evidence of benefit associated with dressings or larvae.

Comments on evidence

Overviews of trials in venous ulceration have commented upon the general poor quality and short follow-up, which limit the generalisability of the research.

Search and appraisal summary

The update literature search for this overview was carried out from the date of the last search, June 2011, to March 2014. For more information on the electronic databases searched and criteria applied during assessment of studies for potential relevance to the overview, please see the Methods section. Searching of electronic databases retrieved 116 studies. After deduplication and removal of conference abstracts, 63 records were screened for inclusion in the overview. Appraisal of titles and abstracts led to the exclusion of 43 studies and the further review of 20 full publications. Of the 20 full articles evaluated, four systematic reviews were updated and four RCTs were added at this update.

About this condition

Definition

Definitions of leg ulcers vary, but the following is widely used: an open sore in the skin of the lower leg due to high pressure of the blood in the leg veins.[1] Some definitions exclude ulcers confined to the foot, whereas others include ulcers on the whole of the lower limb. This overview deals with ulcers of venous origin in people without concurrent arterial insufficiency.

Incidence/ Prevalence

Between 1.5 and 3.0/1000 people have active leg ulcers. Prevalence increases with age to about 20/1000 people aged over 80 years.[2] Most leg ulcers are secondary to venous disease; other causes include arterial insufficiency, diabetes, and rheumatoid arthritis, or, less commonly, autoimmune disease, cancer, or tropical disease.[3] The annual cost to the NHS in the UK has been estimated at £300 million.[4] This does not include the loss of productivity due to illness.

Aetiology/ Risk factors

Leg ulceration is strongly associated with venous disease. However, about one fifth of people with leg ulceration have arterial disease, either alone or in combination with venous problems, which may require specialist referral.[5] Venous ulcers (also known as varicose or stasis ulcers) are caused by venous reflux or obstruction, both of which lead to poor venous return and venous hypertension.

Prognosis

People with leg ulcers have a poorer quality of life than age-matched controls because of pain, odour, and reduced mobility.[6] In the UK, audits have found wide variation in the types of care (hospital inpatient care, hospital clinics, outpatient clinics, home visits), in the treatments used (topical agents, dressings, bandages, stockings), and in healing rates and recurrence rates.[7]

Aims of intervention

To promote healing; to reduce recurrence; to improve quality of life, with minimal adverse effects.

Outcomes

Healing rates (ulcer area, number of ulcers healed, number of ulcer-free limbs, time to complete ulcer healing); recurrence rates (number of new ulcer episodes, number of ulcer-free weeks or months, frequency of dressing/bandage changes, number of people who are ulcer free); quality of life; adverse effects. For the question on prevention of recurrence we have reported recurrence rates, quality of life, and adverse effects only.

Methods

Search strategy BMJ Clinical Evidence search and appraisal date March 2014. Databases used to identify studies for this systematic overview include: Medline 1966 to March 2014, Embase 1980 to March 2014, The Cochrane Database of Systematic Reviews 2014, issue 3 (1966 to date of issue), the Database of Abstracts of Reviews of Effects (DARE), and the Health Technology Assessment (HTA) database. Inclusion criteria Study design criteria for inclusion in this systematic overview were systematic reviews and RCTs published in English, at least single-blinded, and containing 20 or more individuals or limbs (10 in each arm), with no minimum number to be followed up. There was no minimum length of follow-up. We excluded all studies described as 'open', 'open label', or not blinded unless blinding was impossible. BMJ Clinical Evidence does not necessarily report every study found (e.g., every systematic review). Rather, we report the most recent, relevant, and comprehensive studies identified through an agreed process involving our evidence team, editorial team, and expert contributors. Evidence evaluation A systematic literature search was conducted by our evidence team, who then assessed titles and abstracts, and finally selected articles for full text appraisal against inclusion and exclusion criteria agreed a priori with our expert contributors. In consultation with the expert contributors, studies were selected for inclusion and all data relevant to this overview extracted into the benefits and harms section of the overview. In addition, information that did not meet our pre-defined criteria for inclusion in the benefits and harms section may have been reported in the 'Further information on studies' or 'Comment' section. Adverse effects All serious adverse effects, or those adverse effects reported as statistically significant, were included in the harms section of the overview. Pre-specified adverse effects identified as being clinically important were also reported, even if the results were not statistically significant. Although BMJ Clinical Evidence presents data on selected adverse effects reported in included studies, it is not meant to be, and cannot be, a comprehensive list of all adverse effects, contraindications, or interactions of included drugs or interventions. A reliable national or local drug database must be consulted for this information. Comment and Clinical guide sections In the Comment section of each intervention, our expert contributors may have provided additional comment and analysis of the evidence, which may include additional studies (over and above those identified via our systematic search) by way of background data or supporting information. As BMJ Clinical Evidence does not systematically search for studies reported in the Comment section, we cannot guarantee the completeness of the studies listed there or the robustness of methods. Our expert contributors add clinical context and interpretation to the Clinical guide sections where appropriate. Structural changes this update At this update, we have removed the following previously reported question: What are the effects of adjuvant treatments for venous leg ulcers? Data and quality To aid readability of the numerical data in our overviews, we round many percentages to the nearest whole number. Readers should be aware of this when relating percentages to summary statistics such as relative risks (RRs) and odds ratios (ORs). BMJ Clinical Evidence does not report all methodological details of included studies. Rather, it reports by exception any methodological issue or more general issue that may affect the weight a reader may put on an individual study, or the generalisability of the result. These issues may be reflected in the overall GRADE analysis. We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table). The categorisation of the quality of the evidence (high, moderate, low, or very low) reflects the quality of evidence available for our chosen outcomes in our defined populations of interest. These categorisations are not necessarily a reflection of the overall methodological quality of any individual study, because the Clinical Evidence population and outcome of choice may represent only a small subset of the total outcomes reported, and population included, in any individual trial. For further details of how we perform the GRADE evaluation and the scoring system we use, please see our website (www.clinicalevidence.com).

Table.

GRADE Evaluation of interventions for Venous leg ulcers.

Important outcomes Healing rates, Quality of life, Recurrence rates
Studies (Participants) Outcome Comparison Type of evidence Quality Consistency Directness Effect size GRADE Comment
What are the effects of treatments for venous leg ulcers?
5 (707) Healing rates Compression (bandages and stockings) versus no compression 4 –1 0 0 0 Moderate Quality point deducted for incomplete reporting of results in some RCTs
1 (140) Recurrence rates Compression (bandages and stockings) versus no compression 4 –1 –1 –1 0 Very low Quality point deducted for sparse data; consistency point deducted for conflicting results; directness point deducted for inclusion of compression in control group
1 (321) Quality of life Compression (bandages and stockings) versus no compression 4 –2 0 0 0 Low Quality points deducted for incomplete reporting of results (baseline scores not available) and for lack of statistical analysis of between-group difference
3 (1119) Healing rates Compression stockings or tubular garments versus compression bandages 4 –2 0 –2 0 Very low Quality points deducted for incomplete reporting of data and methodological flaws; directness points deducted for inclusion of people with different severities of ulcers and for differences in treatment regimens in both groups, affecting generalisability of results
1 (138) Recurrence rates Compression stockings or tubular garments versus compression bandages 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting of results
1 (60) Healing rates Topical negative pressure versus usual care 4 –1 0 –2 0 Very low Quality point deducted for sparse data; directness points deducted for inclusion of people with non-venous ulcers and for uncertainty about generalisability of results outside a hospital setting
1 (60) Recurrence rates Topical negative pressure versus usual care 4 –1 0 –2 0 Very low Quality point deducted for sparse data; directness points deducted for inclusion of people with non-venous ulcers and for uncertainty about generalisability of results outside a hospital setting
7 (659) Healing rates Oral pentoxifylline versus placebo 4 0 0 –1 0 Moderate Directness point deducted for pentoxifylline being combined with compression
7 (301) Healing rates Low-level laser treatment versus sham treatment or control 4 –2 0 –2 0 Very low Quality points deducted for incomplete reporting of results and for differences in length of follow-up; directness points deducted for treatment inconsistencies between groups and for assessing different measures of healing
1 (120) Healing rates Skin grafts versus usual care or versus each other 4 –1 0 –1 0 Low Quality point deducted for spare data; directness point deducted for intervention combined with compression
1 (47) Healing rates Perforator ligation versus no surgery or versus surgery plus skin grafting in the presence of compression 4 –3 0 0 0 Very low Quality points deducted for sparse data, incomplete reporting of results, and no intention-to-treat analysis
2 (215) Healing rates Minimally invasive surgery versus compression bandages or usual care 4 –1 –1 0 0 Low Quality point deducted for incomplete reporting of results; consistency point deducted for conflicting results
5 (at least 341 people) Healing rates Venous surgery (based on duplex scan) plus compression versus compression alone 4 –1 0 0 0 Moderate Quality point deducted for incomplete reporting of results
3 (745 legs) Recurrence rates Venous surgery (based on duplex scan) plus compression versus compression alone 4 –1 0 0 0 Moderate Quality point deducted for incomplete reporting of results
1 (39) Healing rates Open perforator surgery versus subfascial endoscopic perforator surgery 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting of results
1 (337) Healing rates Therapeutic ultrasound versus no or sham ultrasound 4 0 0 0 0 High
1 (62) Recurrence rates Therapeutic ultrasound versus no or sham ultrasound 4 –1 0 0 0 Moderate Quality point deducted for sparse data
What are the effects of organisational interventions for venous leg ulcers?
4 (at least 159 people) Healing rates Leg ulcer clinics versus usual care 4 –1 0 –2 0 Very low Quality point deducted for incomplete reporting of results; directness points deducted for differences in treatments received by both groups and uncertainty about generalisability of results
2 (246) Recurrence rates Leg ulcer clinics versus usual care 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting of data
What are the effects of interventions to prevent recurrence of venous leg ulcers?
1 (153) Recurrence rates Compression stockings versus no compression 4 –1 0 0 +1 High Quality point deducted for sparse data; effect-size point added for RR <0.5
3 (559) Recurrence rates Compression stockings versus other forms of compression 4 0 0 –1 0 Moderate Directness point deducted for change-over of a large proportion of people from class 3 to class 2 grade of stocking
4 (at least 673) Recurrence rates Surgery plus compression versus compression alone 4 –1 0 0 0 Moderate Quality point deducted for methodological flaws
1 (39) Recurrence rates Open versus endoscopic surgery 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting
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We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.

Glossary

Charing Cross Venous Ulcer Questionnaire

A 21-item questionnaire normally used in conjunction with the Short Form-36 (SF-36) to assess health-related quality of life when venous ulceration is present.

High-quality evidence

Further research is very unlikely to change our confidence in the estimate of effect.

Low-quality evidence

Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.

Minimally invasive surgery

Surgery in which small incisions are made in the skin, and the use of surgical instruments with cameras or direct viewing through eyepieces allows the surgeon to operate. Often performed under local anaesthetic and as a day case.

Moderate-quality evidence

Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.

Multilayer elastomeric high-compression bandages

Usually a layer of padding material followed by one to four additional layers of elastomeric bandages.

Perforator ligation

A procedure that involves tying off the blood vessels that link the deep and superficial venous systems. The one-way valves in these veins prevent flow from the deep to the superficial system. Malfunctioning perforator vessels may be responsible for increasing venous pressure in the superficial venous system, leading to ulceration.

Short Form (SF-12)

A generic, multi-purpose short-form survey with 12 questions selected from the SF-36 Health Survey. The responses, when combined, scored, and weighted, result in two scales of mental and physical functioning and overall health-related quality of life.

Subfascial endoscopic perforator surgery

A minimally invasive endoscopic procedure that eliminates the need for a large incision in the leg. An endoscope is used to visualise directly and tie off incompetent medial calf perforating veins, to decrease venous reflux and reduce ambulatory venous pressure.

Therapeutic ultrasound

Application of ultrasound to a wound, using a transducer and a water-based gel. Prolonged application can lead to heating of the tissues; but, when used in wound healing, the power used is low and the transducer is constantly moved by the therapist, so that the tissue is not heated significantly.

Topical negative pressure

Negative pressure (suction) applied to a wound through an open-cell dressing (e.g., foam, felt).

Unna's boot

An inner layer of zinc oxide-impregnated bandage, which hardens as it dries to form a semirigid layer against which the calf muscle can contract. It is usually covered in an elastomeric bandage.

Very low-quality evidence

Any estimate of effect is very uncertain.

Disclaimer

The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices. Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients. To the fullest extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication.

Contributor Information

E. Andrea Nelson, University of Leeds, Leeds, UK.

Una Adderley, University of Leeds, Leeds, UK.

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BMJ Clin Evid. 2016 Jan 15;2016:1902.

Compression (bandages and stockings) versus no compression

Summary

Compression (bandages and stockings) heals more ulcers compared with no compression.

Compression is used for people with ulcers caused by venous disease who have an adequate arterial supply to the foot.

The effectiveness of compression bandages depends on the skill of the person applying them.

Benefits and harms

Compression (bandages and stockings) versus no compression:

We found one systematic review (search date 2012, 8 RCTs) comparing all forms of compression with no compression,[8] and one subsequent RCT.[9] The RCTs included in the review were heterogeneous, using different forms of compression in different settings and populations. Therefore, the results were not pooled. See Comment for further general information and observational data about harms of compression.

Healing rates

Compression (bandages and stockings) compared with no compression Compression (bandages, stockings, Unna's boot) seems to be more effective than no compression at increasing healing rates (moderate-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing
[8]
Systematic review		 66 people (69 ulcers)
Data from 1 RCT		 Proportion of ulcers healed
21/30 (70%) with compression
15/39 (38%) with no compression
RR 1.82
95% CI 1.15 to 2.89 		Small effect size compression
[8]
Systematic review		 36 people
Data from 1 RCT		 Healing
18/19 (95%) with compression
7/17 (41%) with no compression
RR 2.30
95% CI 1.29 to 4.10 		Moderate effect size compression
[8]
Systematic review		 36 people
Data from 1 RCT		 Healing
12/18 (67%) with compression
4/18 (22%) with no compression
RR 3.00
95% CI 1.19 to 7.56 		Moderate effect size compression
[8]
Systematic review		 200 people
Data from 1 RCT		 Proportion of ulcers healed over 12 weeks
54% with 4-layer elastomeric high-compression bandaging
34% with no compression
Absolute numbers not reported
P <0.001 		Effect size not calculated compression
[8]
Systematic review		 84 people with 87 venous leg ulcers
Data from 1 RCT		 Proportion of ulcers healed 6 months
21/42 (50%) with compression
15/45 (33%) with no compression (primary dressing)
RR 1.50
95% CI 0.90 to 2.50
P = 0.12 		Not significant
[9]
RCT
3-armed trial 		321 people with venous leg ulcers Proportion of ulcers healed 12 weeks
71/107 (66%) with compression (short-stretch bandaging)
64/107 (60%) with compression (4-layer bandaging)
30/107 (28%) with no compression
P <0.001 for each type of compression v no compression 		Effect size not calculated compression
[9]
RCT
3-armed trial 		321 people with venous leg ulcers Proportion of ulcers healed 6 months
77/107 (72%) with compression (short-stretch bandaging)
72/107 (67%) with compression (4-layer bandaging)
31/107 (29%) with no compression
P <0.001 for each type of compression v no compression 		Effect size not calculated compression
[8]
Systematic review		 73 people
Data from 1 RCT		 Mean % reduction in ulcer area (relative to baseline) 7 weeks
69% with compression
54% with no compression (normal saline dressing plus ultrasound therapy)
63% with no compression (normal saline dressing)
P >0.05 for difference across all 3 groups
Between-group differences not assessed
[9]
RCT
3-armed trial 		321 people with venous leg ulcers Time to ulcer healing
9.8 weeks with compression (short-stretch bandaging)
10.4 weeks with compression (4-layer bandaging)
18.3 weeks with no compression
P <0.001 for each type of compression v no compression 		Effect size not calculated compression
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Recurrence rates

Compression (bandages and stockings) compared with no compression We don't know whether compression used for healing is more effective at reducing post-healing recurrence rates compared with no compression in people with venous leg ulcers at 1 year (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Recurrence
[8]
Systematic review		 140 people
Data from 1 RCT		 Recurrence rate 12 months
27/78 (35%) with compression
14/62 (22%) with no compression
RR 1.53
95% CI 0.88 to 2.66
P = 0.13 		Not significant
[8]
Systematic review		 140 people
Data from 1 RCT		 Mean ulcer-free weeks 12 months
20.1 weeks with compression
14.2 weeks with no compression
Difference: 5.9 weeks
95% CI 1.2 weeks to 10.5 weeks 		Effect size not calculated compression
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No data from the following reference on this outcome.[9]

Quality of life

Compression (bandages and stockings) compared with no compression We don't know whether compression is more effective than no compression at improving quality of life in people with venous leg ulcers (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Quality of life
[9]
RCT
3-armed trial 		321 people with venous leg ulcers Score on mental component of the SF-12 (baseline scores not reported; higher score favourable) 12 weeks
47.3 with compression (short-stretch bandaging)
50.0 with compression (4-layer bandaging)
47.2 with no compression
Significance not assessed
[9]
RCT
3-armed trial 		321 people with venous leg ulcers Score on mental component of the SF-12 (baseline scores not reported; higher score favourable) 24 weeks
55.3 with compression (short-stretch bandaging)
55.2 with compression (4-layer bandaging)
56.5 with no compression
Significance not assessed
[9]
RCT
3-armed trial 		321 people with venous leg ulcers Score on physical component of the SF-12 (baseline scores not reported; higher score favourable) 12 weeks
47.5 with compression (short-stretch bandaging)
47.7 with compression (4-layer bandaging)
44.1 with no compression
Significance not assessed
[9]
RCT
3-armed trial 		321 people with venous leg ulcers Score on physical component of the SF-12 (baseline scores not reported; higher score favourable) 24 weeks
53.5 with compression (short-stretch bandaging)
54.0 with compression (4-layer bandaging)
53.1 with no compression
Significance not assessed
[9]
RCT
3-armed trial 		321 people with venous leg ulcers Score on Charing Cross Venous Ulcer Questionnaire (baseline scores not reported; lower score favourable) 12 weeks
21.6 with compression (short-stretch bandaging)
22.4 with compression (4-layer bandaging)
25.1 with no compression
Significance not assessed
[9]
RCT
3-armed trial 		321 people with venous leg ulcers Score on Charing Cross Venous Ulcer Questionnaire (baseline scores not reported; lower score favourable) 24 weeks
21.0 with compression (short-stretch bandaging)
20.9 with compression (4-layer bandaging)
25.1 with no compression
Significance not assessed
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No data from the following reference on this outcome.[8]

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects
[8]
Systematic review		 36 people
Data from 1 RCT		 Withdrawal rate
12 ulcers with compression
6 ulcers with no compression (hydrocolloid dressing)
Not reported
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No data from the following reference on this outcome.[9]

Further information on studies

Many RCTs used a cut-off of 0.9 for the precise ankle/brachial pressure index below which compression is contraindicated (which is higher than the often-quoted value of 0.8; see Comment).

Comment

High levels of compression applied to limbs with insufficient arterial supply or inexpert application of bandages can lead to tissue damage and, at worst, amputation.[10] One observational study (194 people) found that four-layer compression bandaging for several months was associated with toe ulceration in 12 (6%) people.[11]

People thought to be suitable for high-compression treatments (bandages, stockings, and compression leggings) are those with clinical signs of venous disease (ulcer in the gaiter region, from the upper margin of the malleolus to the bulge of the gastrocnemius; staining of the skin around an ulcer; or eczema) and adequate arterial supply to the foot as determined by ankle/brachial pressure index. The precise ankle/brachial pressure index, below which compression is contraindicated, is often quoted as 0.8; however, many RCTs included in the review used the higher cut-off of 0.9.[8] Effectiveness is likely to be influenced by the ability of those applying the bandage to generate safe levels of compression and by the fitting of appropriately sized compression stockings or leggings. Bandages may be applied by the person with the leg ulcer or by a carer, nurse, or doctor. We found no comparisons of healing rates between specialist and non-specialist application of compression. Training improves bandaging technique among nurses.[12] Bandages containing elastomeric fibres can be applied weekly, as they maintain their tension over time. Bandages made of wool, cotton, or both, such as short-stretch bandages, may need to be re-applied more frequently, as they do not maintain their tension.

Substantive changes

Compression (bandages and stockings) versus no compression One systematic review updated[8] and one RCT added.[9] Categorisation unchanged (beneficial).

BMJ Clin Evid. 2016 Jan 15;2016:1902.

Compression stockings versus compression bandages

Summary

Although there is evidence that compression increases healing rates in people with leg ulcers, we don't know which compression technique is most effective.

Evidence from several poor-quality trials found quicker healing or higher healing rates associated with stockings than with bandages.

Benefits and harms

Compression stockings or tubular garments versus compression bandages:

We found two systematic reviews (search dates 2012, 11 RCTs;[8] and 2008, 8 RCTs[13]) and two subsequent RCTs[14] [15] comparing compression stockings or tubular garments with compression bandages. There was some overlap of RCTs (7 RCTs common to both reviews from a total of 12 identified RCTs) between the two reviews.[8] [13] The second review[13] included a meta-analysis for this comparison, so we have reported the synthesised data here, plus data from RCTs that were not included in the meta-analysis. The two reviews do not report recurrence for this comparison, therefore, data on recurrence are reported from one RCT identified by both reviews.[16]

Healing rates

Compression stockings compared with compression bandages Compression stockings may be more effective than high-compression bandaging at increasing healing rates and reducing mean time to healing in people with venous leg ulcers (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing
[13]
Systematic review		 People with venous leg ulcers
8 RCTs in this analysis		 Complete ulcer healing
222/342 (65%) with compression stockings
161/346 (47%) with compression bandages
OR 0.44
95% CI 0.32 to 0.61
P <0.00001
The review reported significant heterogeneity between trials, P = 0.02 		Moderate effect size compression stockings
[13]
Systematic review		 People with venous leg ulcers
7 RCTs in this analysis		 Mean time to healing
11.63 weeks with compression stockings
14.77 weeks with compression bandages
SMD –0.33
95% CI –0.50 to –0.16
P <0.0001
The review reported significant heterogeneity among trials, P = 0.03 		Effect size not calculated compression stockings
[17]
RCT		 80 people with venous leg ulcers
In review [8] 		Complete ulcer healing 2 months
15/40 (38%) with compression stockings plus drug therapy
5/40 (13%) with 2-layer short-stretch bandaging plus drug therapy
P = 0.01 		Effect size not calculated compression stockings
[18]
RCT		 55 people with recurrent, large (mean 13 cm2), and long-lasting (mean 27 months) venous leg ulcers
In review [8] 		Ulcer healing 90–180 days
22% with compression stockings
5% with compression bandages
Absolute numbers not reported
P = 0.40 		Not significant
[18]
RCT		 55 people with recurrent, large (mean 13 cm2), and long-lasting (mean 27 months) venous leg ulcers
In review [8] 		Mean time to healing 180 days
56 days with compression stockings
60 days with compression bandages
P = 0.94 		Not significant
[19]
RCT
3-armed trial 		46 people with venous leg ulcers Percentage of ulcers healed 12 weeks
53% with compression stockings
63% with ProGuide 2-layered bandage system
60% with Profore 4-layered bandage system
Absolute numbers not reported
P >0.05 		Not significant
[14]
RCT
5-armed trial 		147 people with venous leg ulcer Percentage of ulcers healed 2 months
17/30 (59%) with ulcer stocking
17/19 (89%) with multi-layer short-stretch bandage
5/30 (17%) with two-layer short-stretch bandages
6/30 (20%) with Unna's boots
Statistically significant differences between two-layer short-stretch bandages v ulcer stocking and v multi-layer short-stretch bandage
Statistically significant differences between Unna's boots v ulcer stocking and v multi-layer short-stretch bandage
P = 0.03 in all cases and favouring comparator
Statistical significance of other between-group differences not assessed
[15]
RCT		 103 people with venous leg ulcers Percentage of ulcers healed 24 weeks
86% with four-layer bandaging
77% with compression stockings
P = 0.24 		Not significant
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Recurrence rates

Compression stockings compared with compression bandages Compression bandages plus tubulcus may be more effective at reducing recurrence rates than compression bandages alone at 12 months in people with extensive venous leg ulcers (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Recurrence rates
[16]
RCT		 138 people with extensive venous leg ulceration (ulceration surface 20–210 cm2, duration 7 months–28 years)
In review [8] [13] 		Recurrence rate 12 months
16/67 (24%) with multi-layer bandaging system plus tubulcus
18/34 (53%) with multi-layer bandaging system with elastic bandages only
P <0.05 		Effect size not calculated multi-layer bandaging system plus tubulcus
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No data from the following reference on this outcome.[14] [15]

Quality of life

No data from the following reference on this outcome.[8] [13] [14] [15]

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects
[20]
RCT		 134 people
In review [13] 		Adverse effects
with stocking
with short-stretch bandages
Significance not assessed
[21]
RCT		 188 people
In review [13] 		Pain caused by treatment
14% with stocking
0% with short-stretch bandage
Significance not assessed
[13]
Systematic review		 53 people
Data from 1 RCT		 Mean pain scores at bandaging (pain score range: 0–10; lower score = less pain)
1.88 with compression stockings
3.27 with compression bandages
SMD –1.25
95% CI –1.84 to –0.66 		Effect size not calculated compression stockings
[13]
Systematic review		 53 people
Data from 1 RCT		 Withdrawal rate
4 with compression stocking
3 with compression bandage
P value not reported
[13]
Systematic review		 56 people
Data from 1 RCT		 Ulcer pain because of treatment
with compression stocking
with compression bandage
Absolute results not reported
P = 0.017 		Effect size not calculated compression stocking
[13]
Systematic review		 56 people
Data from 1 RCT		 Withdrawal rate
38% with compression stocking
15% with compression bandage
Absolute numbers not reported
P value not reported
Open in a new tab

No data from the following reference on this outcome.[8] [14] [15]

Comment

See Comment in option on Compression bandages and stockings versus no compression for information regarding risks of high levels of compression. We are aware of an RCT published subsequent to our search date, which we will evaluate at the next update for inclusion in this overview.[22]

Clinical guide

Traditionally, stockings were mainly used for post-healing prevention. This limited evidence suggests that hosiery might form part of the menu of compression therapies for healing.

Substantive changes

Compression stockings versus compression bandages One systematic review updated[8] and two RCTs added.[14] [15] Categorisation unchanged (likely to be beneficial).

BMJ Clin Evid. 2016 Jan 15;2016:1902.

Topical negative pressure

Summary

We don't know whether topical negative pressure is beneficial, as we only found one RCT with small numbers that met BMJ Clinical Evidence: criteria.

Benefits and harms

Topical negative pressure versus usual care:

We found two systematic reviews (search dates 2002;[23] and 2004[24]) and one subsequent RCT.[25] Both reviews identified one RCT (24 people), which compared topical negative pressure with simple dressings.[23] [24] The single RCT identified by the reviews was carried out in people with any type of chronic wound, but included some people with venous leg ulcers. However, it may have been too small to detect a clinically important difference in outcomes between topical negative pressure and simple dressings. Therefore, it is not reported further here apart from inclusion in the analysis on adverse effects. The subsequent RCT included 60 people with venous, arteriovenous, or arteriosclerotic leg ulcers.[25]

Healing rates

Topical negative pressure compared with usual care Topical negative pressure (vacuum-assisted closure [VAC]) may be more effective than conventional wound care techniques at reducing time to complete healing in people with venous, arteriovenous, or arteriosclerotic ulcers of at least 6 months' duration (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing
[25]
RCT		 60 hospitalised people with venous, arteriovenous, or arteriosclerotic ulcers of at least 6 months' duration Time to complete healing
29 days with topical negative pressure (VAC)
45 days with control (conventional wound care techniques)
P = 0.001 		Effect size not calculated VAC
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Recurrence rates

Topical negative pressure compared with usual care Topical negative pressure (VAC) may be no more effective at reducing median time to recurrence of ulcers or proportion of healed ulcers that recur compared with conventional wound care techniques in people with venous, arteriovenous, or arteriosclerotic ulcers of at least 6 months' duration (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Recurrence
[25]
RCT		 60 hospitalised people with venous, arteriovenous, or arteriosclerotic ulcers of at least 6 months' duration Median length of time to recurrence
4 months with topical negative pressure (VAC)
2 months with control (conventional wound care techniques)
P = 0.47 		Not significant
[25]
RCT		 60 hospitalised people with venous, arteriovenous, or arteriosclerotic ulcers of at least 6 months’ duration Proportion of healed ulcers that recurred 12 months
52% with topical negative pressure (VAC)
42% with control (conventional wound care techniques)
Absolute numbers not reported
P = 0.41 		Not significant
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Quality of life

No data from the following reference on this outcome.[25]

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects
[23]
Systematic review		 18 people
Data from 1 RCT		 Adverse effects
3/18 (17%) wounds with topical negative pressure
No data with usual care
Significance not assessed
[23]
Systematic review		 24 people
Data from 1 RCT		 Pain
with topical negative pressure
with simple foam dressing
Significance not assessed
[25]
RCT		 60 hospitalised people with venous, arteriovenous, or arteriosclerotic ulcers of at least 6 months' duration Erysipelas
1 with topical negative pressure (VAC)
0 with control (conventional wound care techniques)
Reported as not significant
P value not reported 		Not significant
[25]
RCT		 60 hospitalised people with venous, arteriovenous, or arteriosclerotic ulcers of at least 6 months' duration Pain
3 with topical negative pressure (VAC)
1 with control (conventional wound care techniques)
P value not reported
[25]
RCT		 60 hospitalised people with venous, arteriovenous, or arteriosclerotic ulcers of at least 6 months' duration Wound infection
0 with topical negative pressure (VAC)
1 with control (conventional wound care techniques)
P value not reported
[25]
RCT		 60 hospitalised people with venous, arteriovenous, or arteriosclerotic ulcers of at least 6 months' duration Postoperative bleeding at donor site
0 with topical negative pressure (VAC)
2 with control (conventional wound care techniques)
P value not reported
[25]
RCT		 60 hospitalised people with venous, arteriovenous, or arteriosclerotic ulcers of at least 6 months' duration Non-healing ulcers
1 with topical negative pressure (VAC)
1 with control (conventional wound care techniques)
P value not reported
[25]
RCT		 60 hospitalised people with venous, arteriovenous, or arteriosclerotic ulcers of at least 6 months' duration Cutaneous damage secondary to treatment
7 with topical negative pressure (VAC)
2 with control (conventional wound care techniques)
P <0.05 		Effect size not calculated control
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Further information on studies

One review reported that one of the 10 RCTs of topical negative therapy under way at that time included venous leg ulcers.

In the RCT, all the included people had chronic ulcers (>6 months' duration) and were hospitalised throughout. This limits the applicability of this evidence, as most ulcers are treated outside hospital. Only 43% had venous ulcers in this study; the remainder were arteriovenous or arteriosclerotic ulcers.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2016 Jan 15;2016:1902.

Pentoxifylline (oral)

Summary

Oral pentoxifylline seems to increase ulcer healing in people with venous leg ulcers receiving compression.

Benefits and harms

Oral pentoxifylline versus placebo:

We found one systematic review (search date 2012, 12 RCTs).[26] The systematic review compared pentoxifylline (oxpentifylline), with or without compression, with placebo or with other treatments, in people with venous leg ulcers.[26]

Healing rates

Oral pentoxifylline compared with placebo Oral pentoxifylline plus compression seems to be more effective than placebo plus compression at increasing the proportion of people with healed venous leg ulcers at 8 to 24 weeks (moderate-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing
[26]
Systematic review		 People with venous leg ulcers, receiving compression
7 RCTs in this analysis		 Proportion of people with healed ulcers over 8–24 weeks
221/348 (64%) with pentoxifylline
126/311 (40%) with placebo
RR 1.51
95% CI 1.3 to 1.76 		Small effect size pentoxifylline
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Recurrence rates

No data from the following reference on this outcome.[26]

Quality of life

No data from the following reference on this outcome.[26]

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects
[26]
Systematic review		 People receiving compression Adverse effects
55/297 (18%) with pentoxifylline
33/252 (13%) with placebo
RR 1.27
95% CI 0.89 to 1.83 		Not significant
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Further information on studies

One RCT identified by the review found no significant difference in healing rates at 3 months in people receiving compression between pentoxifylline and defibrotide (11/12 [92%] with pentoxifylline v 9/11 [82%] with defibrotide; RR 1.12, 95% CI 0.81 to 1.55).

Comment

The review provided evidence for there being a benefit for pentoxifylline, both in the presence of compression and also where no compression was used.

Clinical guide

Oral pentoxifylline is not licensed for use in venous disease in all countries. The most commonly reported side effects are gastrointestinal disturbances such as nausea and indigestion, which the affected patients mostly reported as tolerable. However, when making prescribing decisions, the risks of polypharmacy should be considered, as many patients with venous leg ulceration are older adults and may already be taking a variety of drugs for other health conditions.

Substantive changes

Pentoxifylline (oral) One systematic review updated.[26] Categorisation unchanged (beneficial).

BMJ Clin Evid. 2016 Jan 15;2016:1902.

Laser treatment (low-level)

Summary

We don't know whether laser treatment increases healing of ulcers in people treated with compression, compared with sham or control treatment.

Benefits and harms

Low-level laser treatment versus sham treatment or control:

We found two systematic reviews (search date 2001, 4 RCTs;[27] and 1999, 5 RCTs[28]) and four subsequent RCTs (in 5 publications).[29] [30] [31] [32] [33] The second review[28] identified, but did not describe fully, the four RCTs identified by the first review, and did not perform a meta-analysis.

Healing rates

Low-level laser treatment compared with sham or control treatment We don't know whether low-level laser treatment is more effective at increasing ulcer healing rates at 4 weeks to 9 months compared with sham or control treatment (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing
[27]
Systematic review		 People with venous leg ulcers
2 RCTs in this analysis		 Healing rates over 12 weeks
17/44 (39%) with low-level laser treatment
14/44 (32%) with sham treatment
RR 1.21
95% CI 0.73 to 2.03 		Not significant
[27]
Systematic review
3-armed trial 		People with venous leg ulcers
Data from 1 RCT		 Proportion of ulcers healed after 9 months' treatment
12/15 (80%) with laser plus infrared light
5/15 (33%) with non-coherent, unpolarised red light
RR 2.40
95% CI 1.12 to 5.13 		Moderate effect size laser plus infrared light
[29]
RCT
3-armed trial 		65 people receiving compression and drug treatment Reduction in area of ulceration
4.25 cm2 (27%) with laser
5.21 cm2 (39%) with sham laser
2.98 cm2 (18%) with no treatment
Reported as not significant
P value not reported
The RCT may have lacked power to detect clinically important differences 		Not significant
[30] [31]
RCT
3-armed trial 		44 people Reduction in ulcer size
with compression plus low-level laser
with compression plus placebo laser
with compression alone
Absolute results not reported
The RCT reported within-group rather than between-group differences
Reported as not significant
The RCT may have lacked power to detect clinically important differences 		Not significant
[32]
RCT
4-armed trial 		83 people Complete healing
3/21 (14%) with low-level laser therapy plus conservative treatment
3/20 (15%) with conservative treatment alone
P value not reported
Reported as not significant 		Not significant
[33]
RCT		 34 people with venous leg ulcers Complete healing 9 weeks
3/18 (17%) with low-level laser therapy
4/16 (25%) with hydrocellular dressing
P = 0.62 		Not significant
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Recurrence rates

No data from the following reference on this outcome.[27] [28] [29] [30] [31] [32] [33]

Quality of life

No data from the following reference on this outcome.[27] [28] [29] [30] [31] [32] [33]

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects
[30] [31]
RCT
3-armed trial 		44 people Proportion of people with increase in ulcer area
28% with compression plus low-level laser
11% with compression plus placebo laser
Absolute numbers not reported
Significance not assessed
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No data from the following reference on this outcome.[27] [28] [29] [32] [33]

Further information on studies

The laser power, wavelength, frequency, duration, and follow-up of treatment were different for all of the trials.

The review did not assess complete ulcer healing.

Comment

Eye protection is required when using some types of laser, as the high-energy beam may damage the retina.

Substantive changes

No new evidence

BMJ Clin Evid. 2016 Jan 15;2016:1902.

Skin grafting

Summary

There is insufficient evidence to assess the effects of skin grafting for people with venous leg ulcers. We only found one RCT meeting BMJ Cinical Evidence: inclusion criteria.

Benefits and harms

Skin grafts versus usual care or versus each other:

We found one systematic review (search date 2012, 17 RCTs, 1034 people)[34] of skin grafts (autografts, allografts, xerografts, or growth-arrested human keratinocytes and fibroblasts) for venous leg ulcers. In 12 RCTs identified by the review, people also received compression bandaging. Two of these trials (102 people) compared a dressing with an autograft, two trials (45 people) compared fresh allografts with dressings, three RCTs (80 people) compared frozen allografts with dressings, and five trials (552 people) evaluated tissue-engineered products (summarised above). Seven RCTs compared different types of skin graft with each other. The review found insufficient evidence to determine whether skin grafting increased healing rates for venous ulcers because studies were small and generally of poor quality, therefore, no further data are reported here. The review excluded one RCT, that met BMJ Clinical Evidence inclusion criteria for this review and it is, therefore, reported below.[35]

Healing rates

Skin grafts compared with usual care We don't know how porcine extracellular matrix graft skin graft plus compression compares with compression alone at increasing healing of venous ulcers at 12 weeks (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing
[35]
RCT		 120 people with chronic leg ulcer(s) Proportion of people healed at 12 weeks
55% with porcine extracellular matrix graft plus compression
34% with compression alone
Absolute numbers not reported
RR 1.59
95% CI 1.06 to 2.42
RR reported for healing with matrix 		Small effect size matrix graft
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Recurrence rates

No data from the following reference on this outcome.[35]

Quality of life

No data from the following reference on this outcome.[35]

Adverse effects

No data from the following reference on this outcome.[35]

Further information on studies

The review reported that there was no evidence of harm from tissue-engineered skin.

Comment

Porcine-derived products may not be acceptable to some patient groups.[36]

Substantive changes

Skin grafting One systematic review updated.[34] Categorisation unchanged (unknown effectiveness).

BMJ Clin Evid. 2016 Jan 15;2016:1902.

Superficial vein surgery to treat venous leg ulcers

Summary

We don't know whether superficial vein surgery increases healing of ulcers in people treated with compression.

Benefits and harms

Perforator ligation versus no surgery or versus surgery plus skin grafting in the presence of compression:

We found one RCT (47 people) comparing perforator ligation with no surgery or with surgery plus skin grafting.[37] All participants were also treated with a compression bandage.

Healing rates

Perforator ligation compared with no surgery or surgery plus skin grafting We don't know whether perforator ligation is more effective at increasing the proportion of ulcers healed at 1 year or at reducing time to ulcer healing compared with no surgery or surgery plus skin grafting (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing
[37]
RCT
3-armed trial 		47 people with compression Proportion of ulcers healed after 1 year
with perforator ligation
with no surgery
with surgery plus skin grafting
Absolute results not reported
P >0.05
The RCT did not perform an intention-to-treat analysis (ITT), and 7/47 (15%) people withdrew from the trial
The RCT is likely to have been underpowered to detect a clinically important difference among groups 		Not significant
[37]
RCT
3-armed trial 		47 people with compression Time to complete ulcer healing
with perforator ligation
with no surgery
with surgery plus skin grafting
Absolute results not reported
P >0.05
The RCT did not perform an ITT analysis, and 7/47 (15%) people withdrew from the trial
The RCT is likely to have been underpowered to detect a clinically important difference among groups 		Not significant
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Recurrence rates

No data from the following reference on this outcome.[37]

Quality of life

No data from the following reference on this outcome.[37]

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects
[37]
RCT
3-armed trial 		47 people Postoperative complications
0 with perforator ligation
0 with no surgery
0 with surgery plus skin grafting
Significance not assessed
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Minimally invasive surgery versus compression bandages or usual care:

We found two RCTs (215 people), which compared minimally invasive surgery with compression bandages.[38] [39] In the first RCT, people randomised to surgery were treated with a compression bandage before surgery,[38] whereas in the second RCT they wore compression until ulcer healing.[39] The second RCT compared subfascial endoscopic perforator surgery (SEPS) plus superficial venous surgery as required with compression alone.[39]

Healing rates

Minimally invasive surgery compared with compression bandages or usual care We don't know how minimally invasive surgery and compression bandages or usual care compare for reducing time to complete healing and increasing ulcer healing rates (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing
[38]
RCT		 45 people Healing rates
100% with surgery
96% with compression
Absolute numbers not reported
Significance not assessed
The RCT randomised legs rather than people
[38]
RCT		 45 people Median time to complete healing
31 days with surgery
63 days with compression
P <0.005
The RCT randomised legs rather than people 		Effect size not calculated surgery
[39]
RCT		 170 people with venous leg ulcers Proportion of ulcers healed
83% with SEPS plus superficial venous surgery as required
73% with compression alone
Absolute numbers not reported
P = 0.24 		Not significant
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Recurrence rates

No data from the following reference on this outcome.[38] [39]

Quality of life

No data from the following reference on this outcome.[38] [39]

Adverse effects

No data from the following reference on this outcome.[38] [39]

Venous surgery (based on duplex scan) plus compression versus compression alone:

We found one systematic review (search date 2000–2007 only, 5 RCTs, 896 people) comparing superficial venous surgery with compression therapy.[40]

Healing rates

Venous surgery (based on duplex scan) plus compression compared with compression alone Performing venous surgery (based on duplex scan) in people receiving compression is no more effective than compression alone at increasing healing rates at 24 weeks and at 3 years (moderate-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing
[41]
RCT		 341 people
In review [40] 		Healing rates at 24 weeks
65% with surgery plus compression
65% with compression alone
Absolute numbers not reported
HR for healing: 0.84
95% CI 0.77 to 1.24 		Not significant
[42]
RCT		 341 people
Further report of reference [41] 		Healing rates at 3 years
93% with surgery plus compression
89% with compression alone
Absolute numbers not reported
P = 0.73 		Not significant
[40]
Systematic review		 76 legs
Data from 1 RCT		 Healed ulcers
68% with surgery plus compression
64% with compression alone
Absolute numbers not reported
P value not reported
Reported as not significant 		Not significant
[40]
Systematic review		 45 people
Data from 1 RCT		 Healed ulcers
100% with surgery plus compression
96% with compression alone
Absolute numbers not reported
P value not reported
Reported as significant 		Effect size not calculated superficial venous surgery
[40]
Systematic review		 500 legs
Data from 1 RCT		 Healed ulcers
93% with surgery plus compression
89% with compression alone
Absolute numbers not reported
P value not reported
Reported as not significant 		Not significant
[40]
Systematic review		 200 legs
Data from 1 RCT		 Healed ulcers
83% with surgery plus compression
73% with compression alone
Absolute numbers not reported
P value not reported
Reported as not significant 		Not significant
Open in a new tab

Recurrence rates

Venous surgery (based on duplex scan) plus compression compared with compression alone Superficial venous surgery seems more effective than compression therapy at reducing recurrence rates in people with venous leg ulcers (moderate-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Recurrence
[40]
Systematic review		 45 legs
Data from 1 RCT		 Recurrence
9% with surgery plus compression
38% with compression alone
Absolute numbers not reported
Reported as significant
P value not reported 		Effect size not calculated superficial venous surgery
[40]
Systematic review		 500 legs
Data from 1 RCT		 Recurrence
31% with surgery plus compression
56% with compression alone
Absolute numbers not reported
Reported as significant
P value not reported 		Effect size not calculated superficial venous surgery
[40]
Systematic review		 200 legs
Data from 1 RCT		 Recurrence
22% with surgery plus compression
23% with compression alone
Absolute numbers not reported
Reported as not significant
P value not reported 		Not significant
Open in a new tab

No data from the following reference on this outcome.[41] [42]

Quality of life

No data from the following reference on this outcome.[40] [41] [42]

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects
[41]
RCT		 341 people
In review [40] 		Adverse effects 24 weeks
with surgery plus compression
with compression alone
Absolute results not reported
Significance not assessed
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No data from the following reference on this outcome.[42]

Open perforator surgery versus subfascial endoscopic perforator surgery:

We found one systematic review (search date 2003, 1 RCT).[43]

Healing rates

Open perforator surgery compared with subfascial endoscopic perforator surgery We don't know how open perforator surgery and subfascial endoscopic perforator surgery (SEPS) compare at increasing ulcer healing rates at 4 months (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing
[43]
Systematic review		 39 people
Data from 1 RCT		 Healing rates 4 months
17/20 (85%) with SEPS
17/19 (89%) with open surgery
Reported as not significant 		Not significant
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Recurrence rates

No data from the following reference on this outcome.[43]

Quality of life

No data from the following reference on this outcome.[43]

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects
[43]
Systematic review		 39 people
Data from 1 RCT		 Wound infection rates
0% with SEPS
53% with open surgery
Absolute numbers not reported
P <0.001 		Effect size not calculated SEPS
[43]
Systematic review		 39 people
Data from 1 RCT		 Adverse effects
with SEPS
with open surgery
Absolute numbers not reported
Significance not assessed
Open in a new tab

Comment

Several operative approaches are commonly used, including perforator ligation, saphenous vein stripping, and a combination of both procedures. The RCT comparing open perforator surgery with subfascial endoscopic perforator surgery (SEPS) found that hospital stay was shorter with SEPS (4 days with SEPS v 7 days with open surgery).[44] About 25% of people who were offered venous surgery in one study refused it.[45]

Substantive changes

No new evidence

BMJ Clin Evid. 2016 Jan 15;2016:1902.

Therapeutic ultrasound

Summary

We don't know whether therapeutic ultrasound is effective, as results from trials were too inconsistent to draw conclusions.

Benefits and harms

Therapeutic ultrasound versus no or sham ultrasound:

We found one systematic review (search date 2010, 8 RCTs) comparing therapeutic ultrasound with no ultrasound or sham ultrasound for venous leg ulcers.[46] Ultrasound improved ulcer healing in all studies, but a significant difference was found in only four of the eight RCTs, and heterogeneity precluded pooling the RCTs.[46]We also found one subsequent RCT (337 people) comparing low-dose, high-frequency ultrasound plus standard care with standard care alone.[47]

Healing rates

Therapeutic ultrasound compared with standard care Therapeutic ultrasound plus standard care seems to be no more effective than standard care alone at reducing time to healing at 12 weeks and increasing the proportion of people with healed ulcers at 12 months (high-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing
[47]
RCT		 337 people Time to healing 12 weeks
with ultrasound plus standard care
with standard care alone
Absolute results not reported
HR 0.99
95% CI 0.70 to 1.40
P = 0.97 		Not significant
[47]
RCT		 337 people Proportion of people with healed ulcers 12 months
72/168 (43%) with ultrasound plus standard care
78/169 (46%) with standard care alone
P = 0.39 		Not significant
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Recurrence rates

Therapeutic ultrasound compared with standard care Therapeutic ultrasound plus standard care is no more effective than standard care alone at reducing recurrence rates (moderate-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Recurrence
[47]
RCT		 337 people Recurrence
17/31 (55%) with ultrasound plus standard care
14/31 (45%) with standard care alone
P = 0.68 		Not significant
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Quality of life

No data from the following reference on this outcome.[47]

Adverse effects

No data from the following reference on this outcome.[47]

Further information on studies

Mild and severe erythema, local pain, and small areas of bleeding were reported in RCTs identified by the review.

Comment

None.

Substantive changes

No new evidence

BMJ Clin Evid. 2016 Jan 15;2016:1902.

Leg ulcer clinics

Summary

We don't know whether leg ulcer clinics increase healing of ulcers.

Leg ulcer clinics and leg clubs may only be suitable for mobile people.

Benefits and harms

Leg ulcer clinics versus usual care:

We found one systematic review (search date 2001, 1 RCT)[50] and two subsequent RCTs.[51] [52]

Healing rates

Leg ulcer clinics compared with usual care We don't know whether leg ulcer clinics are more effective at increasing ulcer healing rates compared with usual care (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Healing
[50]
Systematic review		 People with leg ulcers
Data from 1 RCT		 Likelihood of healing
with high-compression bandaging in a leg ulcer clinic
with usual care
Absolute results not reported
Cox model: ulcers were 1.65 times more likely to heal when attending a leg ulcer clinic
95% CI 1.15 to 2.35 		Effect size not calculated high-compression bandaging in a leg ulcer clinic
[51]
RCT		 33 people Reduction in ulcer area
with community-based 'Leg clubs'
with usual care
Absolute results not reported
P = 0.004 		Effect size not calculated community-based 'Leg clubs'
[51]
RCT		 33 people Proportion of people healed 12 weeks
7/16 (44%) with community-based 'Leg clubs'
4/17 (24%) with usual care
Reported as not significant
P value not reported 		Not significant
[52]
RCT		 126 mobile people with leg ulcers Healing rate 3 months
58% with clinic care
57% with home care
Absolute numbers not reported
P = 0.5 		Not significant
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Recurrence rates

Leg ulcer clinics compared with home care We don't know whether leg ulcer clinics are more effective than home care at reducing recurrence rates in people with venous leg ulcers (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Recurrence
[52]
RCT		 126 mobile people with leg ulcers Recurrence 1 year
25% with clinic care
22% with home care
Absolute numbers not reported
P = 0.42 		Not significant
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No data from the following reference on this outcome.[50] [51]

Quality of life

No data from the following reference on this outcome.[50] [51] [52]

Adverse effects

No data from the following reference on this outcome.[50] [51] [52]

Further information on studies

All people attending the leg ulcer clinic were treated with high-compression bandaging, whereas only half the people receiving usual care at home were treated with some type of compression bandaging. Compression bandaging is known to be beneficial in the treatment of leg ulcers, and so increased improvement rates in those attending the leg clinic would be expected.

Comment

Clinical guide

Leg ulcer clinics and leg clubs may only be suitable for mobile people.

Substantive changes

No new evidence

BMJ Clin Evid. 2016 Jan 15;2016:1902.

Advice to elevate leg

Summary

We found no RCT evidence about advice to elevate legs, although the intervention makes sense as venous insufficiency is corrected if the leg is elevated above the heart.

Many people with venous leg ulcers have mobility and joint problems, which may make this intervention impractical.

Benefits and harms

Advice to elevate leg versus standard care alone:

We found no systematic review or RCTs.

Comment

Clinical guide

We found no RCT evidence to support the elevation of the leg, although this intervention makes sense as venous insufficiency is corrected if the leg is elevated above the heart. The advantages of leg elevation, such as reduced oedema and increasing venous return, must be weighed against the potential for harm if the cardiovascular system cannot cope with a sudden increase in circulating volume. Many people with venous disease have joint or other mobility problems that mitigate against their being able to elevate their legs for long periods.

Substantive changes

No new evidence

BMJ Clin Evid. 2016 Jan 15;2016:1902.

Advice to keep leg active

Summary

We found no RCT evidence about the effects of advice to keep the leg active, although this intervention makes sense, as venous insufficiency can be reduced by activation of the calf muscle pump.

Many people with venous disease have joint or other mobility problems that may mitigate against increasing their activity levels.

Benefits and harms

Advice to keep leg active versus standard care alone:

We found no systematic review or RCTs.

Comment

Clinical guide

Potential advantages of activity may include reduced leg oedema and increasing venous return.

Substantive changes

No new evidence

BMJ Clin Evid. 2016 Jan 15;2016:1902.

Compression (bandages and stockings) to prevent recurrence

Summary

Compression (bandages and stockings) reduces recurrence of ulcers compared with no compression, and should ideally be worn for life.

Although compression hosiery should ideally be worn for life, arterial sufficiency and changes in leg shape should be regularly assessed prior to provision of replacement hosiery.

Benefits and harms

Compression stockings versus no compression:

We found one systematic review (search date 2012),[53] which found one RCT[54] comparing compression stockings with no compression.

Recurrence rates

Compression stockings compared with no compression Compression stockings are more effective than no compression at reducing ulcer recurrence rates at 6 months; however, we only found one RCT of 153 people (high-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Recurrence
[54]
RCT		 153 people
In review [53] 		Recurrence at 6 months
21% with compression stockings
46% with no compression stockings
Absolute numbers not reported
RR 0.46
95% CI 0.28 to 0.76
NNT for 6 months' treatment 2
95% CI 2 to 5 		Moderate effect size compression stockings
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Quality of life

No data from the following reference on this outcome.[54]

Adverse effects

No data from the following reference on this outcome.[54]

Compression stockings versus other forms of compression:

We found one systematic review (search date 2012, 2 RCTs).[53] The first RCT identified by the review compared two brands of UK class 2 stockings. The second RCT identified by the review compared class 2 and class 3 stockings (see Comment). We found one subsequent RCT.[55]

Recurrence rates

Compression stockings compared with other forms of compression High-compression stockings (UK class 3) seem no more effective than moderate-compression stockings (UK class 2) at reducing recurrence at 5 years (moderate-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Recurrence
[53]
Systematic review		 166 people
Data from 1 RCT		 Recurrence after 18 months
22/92 (24%) with Medi stockings
27/74 (36%) with Scholl stockings
RR 0.74
95% CI 0.45 to 1.20 		Not significant
[53]
Systematic review		 300 people
Data from 1 RCT		 Recurrence after 5 years
59/151 (39%) with class 2 elastic compression
48/149 (32%) with class 3 compression
RR 0.82
95% CI 0.61 to 1.12 		Not significant
[55]
RCT		 93 people Percentage of recurring ulcers
14% with moderate-compression stockings
9% with high-compression stockings
P = 0.651 		Not significant
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Quality of life

No data from the following reference on this outcome.[53] [55]

Adverse effects

No data from the following reference on this outcome.[53] [55]

Further information on studies

Both RCTs found that non-compliance with compression stockings was associated with recurrence.

Comment

The application of high compression to limbs with reduced arterial supply may result in ischaemic tissue damage and, at worst, amputation.[26]

Compression hosiery is classified according to the magnitude of pressure exerted at the ankle; the UK classification states that class 2 stockings are capable of applying 18 mmHg to 24 mmHg pressure and class 3 are capable of applying 25 mmHg to 35 mmHg pressure at the ankle. Other countries use different classification systems. Stockings reduce venous reflux by locally increasing venous pressure in the legs relative to the rest of the body. This effect only takes place while hosiery is worn. The association between non-compliance with compression and recurrence of venous ulceration provides some indirect evidence of the benefit of compression in prevention. People are advised to wear compression stockings for life, and they may be at risk of pressure necrosis from their compression stockings if they subsequently develop arterial disease. Regular re-assessment of the arterial supply is considered good practice, but we found no evidence about the optimal frequency of assessment. Other measures designed to reduce leg oedema, such as resting with the leg elevated, may be useful (see Comment on Advice to elevate legs).

Substantive changes

Compression (bandages and stockings) to prevent recurrence One systematic review updated[53] and one RCT added.[55] Categorisation unchanged (beneficial).

BMJ Clin Evid. 2016 Jan 15;2016:1902.

Superficial vein surgery to prevent recurrence

Summary

Superficial vein surgery may reduce recurrence of venous leg ulcers.

Endoscopic surgery may be more effective than open surgery.

Benefits and harms

Surgery plus compression versus compression alone:

We found one systematic review (search date 1997, 1 RCT),[56] three subsequent RCTs,[38] [39] [41] and one long-term follow-up report.[42]

Recurrence rates

Surgery plus compression compared with compression alone Superficial vein surgery plus compression seems more effective than compression alone at reducing ulcer recurrence rates at 12 months to 3 years (moderate-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Recurrence
[56]
Systematic review		 30 people
Data from 1 RCT		 Recurrence after 18 months
5% with surgery plus compression stockings
24% with compression stockings alone
Absolute numbers not reported
RR 0.21
95% CI 0.03 to 0.80
The RCT was poorly controlled, and its results should be interpreted with caution 		Moderate effect size surgery plus compression stockings
[38]
RCT		 45 people Recurrence rates over 3 years
2/21 (10%) with minimally invasive surgery
9/24 (38%) with compression bandages
P <0.05
The RCT randomised legs rather than people 		Effect size not calculated surgery
[41]
RCT		 500 people Recurrence rates after 12 months
12% with superficial vein surgery plus compression
28% with compression alone
Absolute numbers not reported
HR –2.76
95% CI –4.27 to –1.78
P <0.0001 		Effect size not calculated surgery plus compression
[42]
RCT		 500 people with leg ulcers
Further report of reference [41] 		Recurrence rates 4 years
31% with superficial vein surgery plus compression
56% with compression alone
Absolute numbers not reported
Reported as significant
P <0.001 		Effect size not calculated surgery plus compression
[39]
RCT		 170 people Recurrence rates 27 months
22% with subfascial endoscopic perforator surgery plus compression
23% with compression alone
Absolute results reported graphically
Reported as not significant 		Not significant
Open in a new tab

Quality of life

No data from the following reference on this outcome.[38] [39] [41] [42] [56]

Adverse effects

No data from the following reference on this outcome.[38] [39] [41] [42] [56]

Open versus endoscopic surgery:

We found one systematic review (search date 2003, 1 RCT),[43] which compared open surgery with subfascial endoscopic perforator surgery (SEPS), and a subsequent long-term follow-up report[57] of the RCT identified by the review. We found one RCT that gave information on adverse effects.[44]

Recurrence rates

Open compared with endoscopic surgery Open surgery may be less effective than endoscopic surgery at reducing ulcer recurrences at 12 months (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Recurrence
[57]
RCT		 39 people
Further report of reference [43] 		Recurrences at 12 months
4 (22%) with open surgery
2 (12%) with SEPS
P = 0.044 		Effect size not calculated SEPS
Open in a new tab

No data from the following reference on this outcome.[44]

Quality of life

No data from the following reference on this outcome.[43] [44] [57]

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects
[57]
RCT		 39 people
Further report of reference [43] 		Adverse effects
with open surgery
with SEPS
Absolute numbers not reported
Significance not assessed
[44]
RCT		 People with leg ulcers Wound infection rates
53% with open surgery
0% with SEPS
Absolute numbers not reported
P <0.001 		Effect size not calculated SEPS
Open in a new tab

Comment

Although vein surgery has the usual risks of surgery and anaesthesia, advances in surgical techniques are likely to make this an increasingly acceptable treatment option for patients with venous leg ulcers.

Substantive changes

No new evidence

Articles from BMJ Clinical Evidence are provided here courtesy of BMJ Publishing Group

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