Table.
GRADE evaluation of interventions for venous leg ulcers
| Important outcomes | Healing rates, recurrence rates, adverse effects | ||||||||
| Number of studies (participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What are the effects of standard treatments for venous leg ulcers? | |||||||||
| 7 (467) | Healing rates | Compression bandages and stockings v no compression | 4 | 0 | 0 | 0 | 0 | High | |
| 2 (299) | Healing rates | Compression stockings v short-stretch bandages | 4 | –2 | –1 | –2 | 0 | Very low | Quality point deducted for incomplete reporting of results and for methodological flaws. Consistency point deducted for conflicting results. 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 |
| 6 (679) | Healing rates | Multilayer elastomeric high-compression regimens v each other | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for incomplete reporting of results. Directness point deducted for inclusion of multiple interventions in comparison |
| 4 (280) | Healing rates | Multilayer elastomeric high-compression regimens v single-layer bandage | 4 | 0 | 0 | 0 | 0 | High | |
| 9 (908) | Healing rates | Multilayer elastomeric high-compression bandages v short-stretch bandages or Unna’s boot | 4 | 0 | –1 | 0 | 0 | Moderate | Consistency point deducted for conflicting results |
| 4 (385) | Healing rates | Multilayer elastomeric high-compression bandages v non-elastmeric high-compression bandages | 4 | 0 | –1 | 0 | 0 | Moderate | Consistency point deducted for conflicting results |
| 1 (24) | Healing rates | Single-layer non-elastic system v multilayer elastic system | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Directness point deducted for uncertainty about generalisability of results in people with different conditions |
| 1 (38) | Healing rates | Single-layer non-elastic system v multilayer non-elastic system | 4 | –2 | 0 | 0 | 0 | Low | Quality points deduced for sparse data and incomplete reporting of results |
| 1 (60) | Healing rates | Peri-ulcer injection of granulocyte-macrophage colony-stimulating factor v placebo | 4 | –1 | 0 | 0 | +1 | High | Quality points deduced for sparse data. Effect-size point added for RR less than 5 |
| 8 (883) | Healing rates | Semi-occlusive dressings v simple low-adherent dressings | 4 | 0 | –1 | 0 | 0 | Moderate | Consistency point deducted for conflicting results |
| 1 (89) | Healing rates | Alginate dressings v zinc oxide dressings | 4 | –1 | –1 | 0 | 0 | Low | Quality point deduced for sparse data. Consistency point deducted for conflicting results |
| 5 RCTs (at least 115 people) | Healing rates | Intermittent pneumatic compression plus compression stockings v compression stockings or bandages alone | 4 | –1 | –1 | 0 | 0 | Low | Quality points deduced for sparse data. Consistency point deducted for conflicting results |
| 19 (at least 263 people) | Healing rates | Topical antimicrobial agents v placebo or usual care | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for incomplete reporting of results. Directness point deducted for assessing different outcome in one study |
| 1 (66) | Healing rates | Calcitonin gene-related peptide (topical) plus vasoactive intestinal polypeptide v placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 1 (40) | Healing rates | Topical mesoglycan v plant-based extract | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 1 (60) | Healing rates | Topical negative pressure v 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 (94) | Healing rates | Topical recombinant human keratinocyte growth factor 2 plus compression v compression | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 2 (135) | Healing rates | Platelet-derived growth factor v placebo | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| At least 27 RCTs (at least 792 people) | Healing rates | Hydrocolloid (occlusive) dressings v simple dressings in the presence of compression | 4 | 0 | 0 | 0 | 0 | High | |
| 5 (351) | Healing rates | Hydrocolloids v other occlusive or semi-occlusive dressings | 4 | 0 | 0 | 0 | 0 | High | |
| 3 (388) | Healing rates | Different occlusive or semi-occlusive dressing (excluding hydrocollids) v each other | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (86) | Healing rates | Topically applied autologous platelet lysate v placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 1 (200) | Healing rates | Topically applied freeze-dried keratinocyte lysate v vehicle or usual care | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| What are the effects of adjuvant treatments for venous leg ulcers? | |||||||||
| 8 (682) | Healing rates | Oral pentoxifylline v placebo | 4 | 0 | 0 | 0 | 0 | High | |
| 2 (345) | Healing rates | Cultured allogenic bilayer skin replacement v non-adherent dressing | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 5 (723) | Healing rates | Flavonoids plus compression v compression alone | 4 | –1 | –1 | 0 | +1 | Moderate | Quality point deducted for incomplete reporting of results. Consistency point deducted for conflicting results. Effect-size point added for RR/OR greater than 2 but less than 5 |
| 4 (488) | Healing rates | Oral sulodexide plus compression v compression alone | 4 | 0 | 0 | 0 | 0 | High | |
| 1 (183) | Healing rates | Systemic mesoglycan plus compression v placebo plus compression | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 2 (70) | Healing rates | Cultured allogenic single-layer dermal replacement v usual care | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 1 (87) | Healing rates | Intravenous prostaglandin E1 v placebo | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and for methodological flaws |
| 8 (420) | Healing rates | Low-level laser treatment v sham treatment | 4 | –2 | 0 | –2 | 0 | Very low | Quality points deducted for incomplete reporting of results and for differences in length of follow-up. Consistency point deducted for conflicting results. Directness points deducted for treatment inconsistencies between groups and for assessing different measures of healing |
| 1 (reported as 'small') | Healing rates | Oral aspirin v placebo | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data and for methodological weaknesses |
| 2 (115) | Healing rates | Oral rutosides v placebo | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 1 (165) | Healing rates | Oral thromboxane alpha2 antagonists v placebo | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 12 (888) | Healing rates | Different types of skin grafts v other treatments for leg ulcers | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for poor studies and insufficient evidence. Directness point deducted for generalisability of results |
| 1 (47) | Healing rates | Perforator ligation v no surgery or v surgery plus skin grafting | 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 v 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 |
| 1 (341) | Healing rates | Venous surgery (based on duplex scan) plus compression v compression alone | 4 | 0 | 0 | 0 | 0 | High | |
| 1 (39) | Healing rates | Open perforator surgery v subfascial endoscopic perforator surgery | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data, and incomplete reporting of results |
| 1 (39) | Adverse effects | Open perforator surgery v subfascial endoscopic perforator surgery | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| What are the effects of organisational interventions for venous leg ulcers? | |||||||||
| 2 (at least 33 people) | Healing rates | Leg ulcer clinics v 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 |
| What are the effects of advice about self-help interventions in people receiving usual care for venous leg ulcers? | |||||||||
| No systematic review or RCTs found | |||||||||
| What are the effects of interventions to prevent recurrence of venous leg ulcers? | |||||||||
| 1 (153) | Recurrence rates | Compression stockings v no compression | 4 | –1 | 0 | 0 | +1 | High | Quality point deducted for sparse data. Effect-size point added for RR less than 0.5 |
| 2 (466) | Recurrence rates | Compression stockings v other forms of compression | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for change over from higher to lower class |
| 4 (673) | Recurrence rates | Surgery plus compression v compression alone | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for methodological flaws |
| 1 RCT and 1 report (39) | Recurrence rates | Open v endoscopic surgery | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 1 (139) | Recurrence rates | Oral rutoside v placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 1 (48) | Recurrence rates | Oral stanozolol v placebo | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and uncertainty about duration of follow-up |
Type of evidence: 4 = RCT; 2 = Observational Consistency: similarity of results across studies Directness: generalisability of population or outcomes Effect size: based on relative risk or odds ratio