Adaptive compression therapy for venous leg ulcers: a clinically effective, patient‐centred approach

Abstract

A prospective, randomised, 12‐week study was performed to evaluate the efficacy and tolerability of two compression methods for venous leg ulcers (VLUs); a new adaptive compression therapy (ACT) system, combining intermittent and sustained pneumatic compression (n = 38) and a conventional four‐layer bandage system (n = 52). Primary outcomes were ulcer healing and safety. Secondary outcomes were comfort, compliance, ulcer pain, patient‐perceived product performance and quality of life. Ulcer healing rate was similar (31·6% versus 42·3%, respectively, P = 0·30) between the treatments. Adverse events and patient‐rated comfort were also similar. Average daily usage for the dual system was 10·5 and 1·8 hours in the sustained and intermittent modes, respectively, representing its use during 71% of waking hours. Predicted final ulcer pain was also similar (P = 0·68). Performance was subjectively better for adaptive compression and significantly higher for exudate management (P = 0·04), skin protection (P < 0·001), removal ease (P = 0·0007), bathing (P < 0·0001) and sleep comfort (P = 0·0405). The adjusted final quality‐of‐life score was 0·1025 higher for adaptive compression (P = 0·0375). Subjects with healed ulcers attained higher final scores than unhealed subjects (P = 0·0004). This study provides evidence that ACT is comparably efficacious to successfully heal VLUs compared with four‐layer bandage management but is better accepted and achieves higher patient‐reported quality‐of‐life scores in these challenging patients.

Introduction

Venous leg ulcers (VLUs) represent morbid clinical challenges, impair quality of life (QoL) and are costly. Clinically effective therapies that might lower the high morbidity and cost of VLU treatment therefore represent a need for key clinical care.

Standard of care usually consists of local wound management combined with prescription of compression therapy. Compression is typically applied using bandages or stockings. In situations where patients are unable to apply high compression due to co‐morbidities (e.g. arthritis, obesity and weakness), patient compliance is inevitably poor 1, 2, 3, 4. Consequently, other therapeutic options have been sought to provide sufficient compression to the leg while supporting patient compliance.

Multi‐component compression systems represent one of the key choices available to the clinician and VLU patient. The four‐layer bandage system based on the original Charing Cross method 5, 6 is often considered the gold standard of compression. However, multi‐component compression bandage systems are also associated with significant limitations,7 including inconsistency in application techniques, pressure loss, bulkiness, bandage slippage and decreased patient QoL.

It has been recognised that improvements in VLU treatment might be achieved if effective compression could be prescribed, in association with preservation of patient‐reported QoL and functional independence. A new device has been developed, which is capable of applying graded compression profiles similar to that produced by the Charing Cross four‐layer bandage system, but which does not rely on the professional application of compression bandages. The adaptive compression therapy (ACT) device provides both controlled, sustained compression and intermittent pneumatic compression (IPC). The dual‐mode functions are controlled by a microprocessor that links four pneumatic pressure cuffs while enabling different target pressures within each sequential cuff in the foot, ankle and calf. The device was designed to be easy to use and to thus encourage patient compliance with therapy as a key factor to support ulcer healing.

The objective of this study was to evaluate efficacy, functionality, safety, patient perceptions and impact on QoL of this pneumatic compression device compared to a standard four‐layer bandage system for the treatment of patients with VLUs.

Methodology

Study design

This was a prospective, stratified and randomised study comparing two methods of compression for the treatment of VLUs, an ACT device (ACTitouch, Tactile Medical, Minneapolis, MN) and a four‐layer bandage system (4‐LB) (Profore™ Multi‐Layer Bandaging System, Smith & Nephew Medical Wound Management, Hull).

Ethical considerations

This study conformed to the ethical guidelines of the Declaration of Helsinki as amended, October 2008 8. The study was conducted in compliance with the Good Clinical Practice guidelines 9 and ISO 14155:2003 Clinical Investigation of Medical Devices for Human Subjects, parts 1 and 2 10. An ethics review was conducted by a duly sanctioned Ethics Committee in each of the countries in which the study was conducted. All participants provided written informed consent before study enrolment.

Study participants

All subjects were outpatients over 18 years of age, were willing and able to wear the compression and follow the clinical study plan. Study inclusion required an ankle brachial pressure index (ABPI) of ≥ 0·8 and at least one VLU ≥2 cm² in size but ≤15 cm in any one dimension, treated by compression therapy. All patients had a Duplex investigation to determine anatomic classification (Table 1).

Table 1.

Demographics and baseline ulcer characteristics

Characteristic	4‐LB	ACT
Gender
Male	29 (56%)	17 (45%)
Female	23 (44%)	21 (55%)
Age
Mean (SD)	62·6 (15·41)	60·9 (16·72)
Ulcer location
Foot	1 (2%)	1 (3%)
Ankle	20 (39%)	20 (53%)
Calf	12 (23%)	3 (8%)
Gaiter	19 (37%)	14 (37%)
Duration of ulcer (years)
Mean (SD)	2·57 (4·84)	2·43 (4·05)
Ulcer size (cm2)
Mean (SD)	14·18 (15·15)	14·08 (20·40)
Ulcer depth
Superficial	17 (33%)	5 (13%)
Shallow	32 (62%)	32 (84%)
Deep	3 (6%)	1 (3%)
Level of exudate
None	1 (2%)	1 (3%)
Mild	19 (37%)	13 (34%)
Moderate	26 (50%)	21 (55%)
Heavy	6 (12%)	3 (8%)
(missing)	0	1 (3%)
Level of oedema
Minimal	32 (62%)	18 (47%)
Moderate	16 (31%)	14 (37%)
Considerable	4 (8%)	5 (13%)
Odour with pre‐study dressing in place
None	33 (64%)	24 (63%)
Faint	11 (21%)	9 (24%)
Moderate	7 (14%)	4 (11%)
Strong	1 (2%)	1 (3%)
ABPI
Mean (SD)	1·15 (0·18)	1·09 (0·15)
Anatomic classification
Superficial	21 (41%)	15 (41%)
Deep	15 (29%)	9 (24%)
Perforator	4 (8%)	5 (14%)
Superficial/perforator	2 (4%)	2 (5%)
Superficial/deep	2 (4%)	1 (3%)
Superficial/deep/perforator	6 (12%)	5 (%)
Deep/perforator	1 (2%)	0
(missing)	1 (2%)	1 (3%)
Ulcer stratification
<10 cm2 / <6 months duration	16 (31%)	12 (32%)
<10 cm2 / ≥6 months duration	21 (40%)	14 (37%)
≥10 cm2 / <6 months duration	4 (8%)	2 (5%)
≥10 cm2 / ≥6 months duration	11 (21%)	10 (26%)

4‐LB, four‐layer bandage system; ACT, adaptive compression therapy; ABPI, ankle brachial pressure index.

Exclusion criteria included skin sensitivity to any of the compressive components, participation in any clinical study within the previous 3 months, episode of deep vein thrombosis within the previous 3 months or leg circumferences that exceeded the fit range of the device. Patients with diabetes were excluded if there was inadequate metabolic control, if the patient had a history of blood sugar‐related hospitalisation within the last 6 months or had diabetic foot lesions.

Study treatments

The ACT is a low‐voltage device operated from a battery or electrical adaptor (Figure 1). The device uses pneumatic technology to apply controlled gradient compression to the lower leg. It consists of a foot and ankle cuff, a calf cuff and an electronic control unit. The cuffs are linked together to form one complete functional sleeve. The control unit clips into the sleeve for normal operation but can be removed by the healthcare professional to access treatment compliance data. The device is used in conjunction with an associated undersock (Figures 1 and 2).

Figure 1.

ACT device: (A) outer side view and (B) underside views.

Figure 2.

Application of the ACT device. (A) Donning of undersock; (B) stepping into foot section; (C) fastening of foot section with hook and loop straps; (D) fully applied foot section; (E) fastening of calf section; (F) fully applied.

Three layers of materials are bonded together to form the sleeve with the inner and mid layers consisting of polyurethane material to form the inflatable elements and an outer cover layer consisting of highly durable polyurethane‐coated nylon. The sock is knitted from a blend of cotton, polyester and nylon fibres and provides padding and moisture wicking properties.

There are four separate bladders within the calf cuff that allow different pressures to be applied independently to the upper, mid and lower areas of the calf. The lower calf cuff is linked pneumatically to the ankle region to ensure that the same pressure level is applied throughout the region. The pressure is controlled using pressure transducers in the pneumatic supply system. The device design allows for subject mobility during use in the sustained compression mode and is therefore powered by a lightweight rechargeable battery. When the device is used in the IPC mode or is being recharged, it is powered by a plug‐in power adaptor (Figure 1). The device was designed to provide graded compression when operated in the sustained mode, supplemented by intermittent compression for up to 2 hours per day when operated in the IPC mode. The sustained compression mode provides graded compression of 40 mmHg at the foot and ankle, 30 mmHg mid‐calf and 20 mmHg at the knee. The IPC mode provides intermittent compression of 50 mmHg at the foot and ankle, 45 mmHg at the mid‐calf and 40 mmHg at the knee. These optimal IPC pressure profiles were derived from previous pressure dose–response studies 11.

The comparator treatment was a high‐compression 4‐LB kit based on the original Charing Cross method intended to provide 40 mmHg compression at the ankle when properly applied 6. Four different sizes of the 4‐LB kits were available dependent on ankle size. Application of the 4‐LB kits followed manufacturer instructions and were performed by a trained clinician.

ACT subjects were instructed to wear the device during all waking hours in sustained mode for most of the day, supplemented with 2 hours of IPC at a time of their choosing. Removal of the device was allowed for bathing and overnight sleep. Subjects randomised to 4‐LB were instructed to wear the bandages 24 hours per day without removal even when sleeping or (sponge) bathing. All subjects received local ulcer management with a standardised dressing of non‐adherent Versiva^® XC™ held in place with Tubifast™. For deep ulcers, AQUACEL^® Hydrofiber^® was permitted as filler. Subjects were evaluated in clinic weekly for protocol assessments and more often as clinically indicated for dressing changes and reapplication of 4‐LB, which was changed at least weekly. The study period was 12 weeks or until the subject's wound healed or they were withdrawn from the study.

Outcome measures

The primary outcomes included inter‐group comparisons of safety (frequency and type of adverse events) and the number of ulcers that attained complete closure. Secondary outcomes included treatment compliance (ACT group only), ulcer pain, device comfort and patient perceptions of treatment performance and QoL.

Compliance for ACT was measured by the amount of time the subject used the device in both the sustained compression and IPC modes. These data were recorded both objectively by the device and subjectively by the subject in a study diary. There was no measure of compliance for 4‐LB due to lack of an objective automated method.

Ulcer pain was evaluated at baseline and end of study and was assessed using a numeric 10‐point visual analogue scale (VAS) with values from 0 (no pain at all) to 10 (worst pain imaginable).

Comfort was evaluated by the patient at each visit using a 4‐point descriptive scale from ‘Very Comfortable’ = 4 to ‘Very Uncomfortable’ = 1.

Patients evaluated treatment performance at the end of the study period. Performance perceptions were evaluated using a 5‐point descriptive scale from ‘Excellent’ = 5, to ‘Unacceptable’ = 1.

Ulcer healing was evaluated using acetate tracing of the wounds. Tracings were obtained at baseline and at weeks 2, 4, 6, 8 and 12 unless the ulcer was healed or the patient withdrew from the study.

QoL was measured using the EQ‐5D‐3 L Health Questionnaire 12 completed at baseline and the end of the study. This self‐completed, standardised measure of health status has been validated across a wide range of conditions and provides a simple, generic measure of health for clinical and economic appraisal 13. The questionnaire consists of two parts: a descriptive system and a VAS.

The descriptive system comprised five dimensions: mobility, self‐care, usual activities, pain/discomfort and anxiety/depression. Respondents indicate their health status by choosing one of the three levels: “1 = no problems”, “2 = some problems” and “3 = severe problems” for each dimension 14. The individual health states are then converted into a single‐index score by applying a standardised formula 13, 15.

The VAS portion records the respondent's self‐rated health on a standardised line with endpoints representing the ‘Best imaginable health state’ and ‘Worst imaginable health state’. The VAS scores are intended to measure individual patient‐based health status while the index scores are intended to measure population‐based health status. As this study was not concerned with ranking the individual patients within an index population, only the index scores were used in the analysis.

Randomisation

Patients were randomly assigned treatments according to a pre‐determined randomisation schedule generated for each study centre. There were four separate levels of stratification defined by two levels of ulcer size (<10 cm² and ≥10 cm²) and two levels of ulcer duration (<6 months and ≥6 months). As it was anticipated that each of the participating study centres would enrol at least ten patients, randomisation was in blocks of five. No attempt was made to blind either the patients or the study investigators to the treatment as the distinct appearance and application of each compressive modality made blinding impossible.

Statistical methods

Outcome summaries are presented by treatment group and all statistical analyses (except safety data) were performed on an intent‐to‐treat (ITT) basis. Therefore, all randomised subjects who had exposure to the treatment were included in the ITT population. The safety analysis was performed on the entire population of enrolled patients. Missing data were not imputed; however, adverse events with missing causality (relationship to treatment) were imputed as being related.

Baseline data were assessed with either a two sample t‐test or χ ² analysis, as appropriate. QoL data were assessed with a multi‐variable linear regression model that adjusted for both differences in baseline data and ulcer healing status at the end of the study. Patient perception of product performance was assessed by numeric encoding of the responses with a two‐sample t‐test of the group means.

Ulcer healing rate was assessed using a χ ² analysis and the reduction in wound size was assessed using a two‐sample t‐test of the mean group‐wise changes. Time to wound healing was assessed with a Kaplan–Meier analysis, utilising a log‐rank significance test. All statistical tests were performed with a two‐sided significance level of 5%.

The sample size was not based on a power analysis. A total of 86 patients were to be enrolled in the study (90 actual). For an estimation of healing rate (with the anticipated healing rate of 65% for both of the two arms), it was postulated that 34 subjects ensure that the error in estimating the healing rate will be less than or equal to ±12% using a two‐sided 90% confidence interval. The sample size was selected clinically to provide an adequate exposure and number of observations to characterise the safety and key performance characteristics of the ACT device while including a parallel group comparator to establish a baseline and point of comparison.

Results

Patient enrolment

The study was conducted over a 2‐year period. A subject flow diagram is provided in Figure 3.

Figure 3.

Subject flow diagram.

Subject demographics and baseline characteristics

Subject demographics and baseline ulcer characteristics are summarised in Table 1.

Patient characteristics at baseline were similar between the two groups. No statistical differences were found for either mean ulcer size (P = 0·98) or mean duration of ulcer (P = 0·88).

Wound healing

Twelve subjects (32%) healed with ACT and 22 subjects (42%) healed with 4‐LB therapy (P = 0·30). Similarly, no significant difference was found comparing the time to healing using Kaplan–Meier analysis (64·0 versus 48·5 days, P = 0·85). The mean (SD) absolute reduction in ulcer size from baseline was 4·11 (7·93) cm² for ACT and 8·04 (10·22) cm² for the 4‐LB. The mean percentage reduction in ulcer size was 50·20% for ACT and 65·24% for the 4‐LB (P = 0·06).

Adverse events

Treatment‐related adverse events (AEs) were reported for 66 subjects in the full study cohort, including 29 (76%) in the ACT group and 37 (71%) in the 4‐LB group. The type and frequency of AEs reported were similar between the treatments and non‐serious AEs were relatively common for both groups. There were no serious AEs related to treatment reported for either treatment group. A summary of frequency of the most common types of AEs is provided in Table 2.

Table 2.

Number (%) of patients reporting the most common study treatment‐related AEs

Description	ACT (n = 38)	4‐LB System (n = 52)
Pain in lower leg	16 (42%)	21 (40%)
Maceration	15 (40%)	5 (10%)
Eczema	3 (8%)	13 (25%)
Erythema	5 (13%)	7 (14%)
Oedema	5 (13%)	1 (2%)
Blisters/skin breakdown	4 (11%)	7 (14%)
Dry/flaky skin under device	2 (5%)	7 (14%)
Wound enlargement/deterioration	2 (5%)	6 (12%)

ACT, adaptive compression therapy; 4‐LB, four‐layer bandage system; AEs, adverse events.

Health‐related QoL

χ ² analysis showed no baseline differences between the two treatment groups for any of the five individual dimensions of the EQ‐5D‐3 L; however, there was a significant cumulative effect at baseline across the five dimensions in favour of the 4‐LB group. The mean (SD) baseline index score was 0·58 (0·25) for ACT and 0·69 (0·22) for the 4‐LB (P = 0·0411).

Multi‐variable linear regression modelling was used to predict final EQ‐5D‐3 L index scores and these data are presented in Figure 4. The model predicted a final index score for ACT to be 0·1025 higher than the final index score for 4‐LB (P = 0·0375). Similarly, the model predicted the final index score for patients with healed ulcers to be 0·1774 higher than for patients with ulcers that did not heal (P = 0·0004).

Figure 4.

Predicted Final EQ‐5D‐3L index score by baseline score, study arms and ulcer healing status. Solid lines are the modelled fitted lines. Dotted lines are the 95% confidence intervals. The vertical separation between the lines represents the treatment effects for the combinations of treatment arm and ulcer‐healed status.

Patient comfort

A numeric encoding of the patient comfort ratings, assessed weekly using a 4‐point scale, was derived. Mean scores are shown in Figure 5. Patients rated comfort between the two compression systems equally.

Figure 5.

Mean patient ratings of comfort obtained during weekly clinic visits.

Compliance with ACT

The mean (SD) daily wear time of ACT based on data recorded by the control unit was 10·54 (8·64) hours in sustained compression mode and 1·76 (1·48) hours in IPC mode. ACT subjects also manually recorded device use daily in both modes. Although in general agreement with the automated tracking, the subject recorded data was slightly higher; mean (SD) daily wear time in sustained mode was 11·48 (2·48) hours and 2·03 (0·39) hours in IPC mode.

Ulcer pain

At baseline, the mean (SD) pain ulcer score for the ACT group, 4·6 (2·8), was significantly higher than for the 4‐LB group, 3·2 (2·2) (P = 0·0124). After adjusting for these baseline differences, an ANCOVA linear regression model showed no significant difference in the predicted final pain score between the treatment groups (difference = 0·2325, P = 0·6755).

Patient perceptions of treatment performance

Patient‐centred aspects of treatment performance rated at the end of the study were assessed using a 5‐point scale from Excellent =5 to Unacceptable =1. As with patient comfort, a numeric encoding of the ratings were derived. The mean scores are shown in Figure 6. ACT was rated higher than 4‐LB in all categories except for discreteness under clothing and was rated significantly higher in exudate management, skin protection, removal ease, bathing and sleep comfort.

Figure 6.

Mean ± SD of patient ratings of treatment performance.

Discussion

The delivery of effective compression serves as the essential element of venous care, particularly in the management of venous ulcers 16. Adherence to therapy is central to clinical efficacy but may not be reliably achieved in contemporary care. This study demonstrates that a new active, dual‐function pneumatic system can provide comparable clinical efficacy, with greater ease of use and improved QoL to support the venous health of patients with VLU.

The use of compression bandages as a treatment modality for VLUs is well established 14, 17, 18, 19, 20, 21, 22. Compressive bandages are intended to be worn 24 hours per day, but their use is associated with many well‐recognised deficiencies. There has been relatively little advancement in venous leg compressive bandaging technology as the introduction of the original Charing Cross 4‐LB system over 20 years ago. The new ACT, described in this study, applies graded compression with the added benefit of provision of ‘on‐demand IPC’. In spite of the ambiguous result of a Cochrane review, 23 the benefits of IPC treatment in combination with sustained compression are well recognised and considered a good choice for improved outcomes in advanced venous disease 16. This dual‐mode compressive system was designed to provide easy and convenient garment self‐application and removal.

Unlike 4‐LB, ACT does not require the use of bulky bandages and can be applied and removed with ease by the user (not requiring nursing personnel). This is an important feature as it supports increased patient involvement in treatment with the freedom to remove the device for bathing and sleep. As patients experience more control over their treatment with increased comfort and ease of use, one should expect a higher level of compliance.

Another important clinical advantage of ACT is the predictable and consistent compression regardless of variation in application by the patient. The adaptive compression function automatically measures interface pressure and adjusts inflation every 30 minutes to maintain the pre‐set target pressures. By contrast, pressure levels diminish to a variable degree after application of conventional bandages due to several factors, including material fatigue, oedema reduction and activity of the patient. A mean pressure loss of 30% has been shown after 7 days of wear 24.

This study provides data that demonstrate that both ACT and 4‐LB can achieve similar wound‐healing rates. Therefore, patient‐centred factors and treatment health economics might be included as key factors in selection of the VLU treatment, as would occur for the choice of any cardiovascular therapy. In this study, patient comfort was equally rated as generally comfortable for both modalities. Likewise, ulcer pain was rated similarly between the two modalities.

Comparison of subject compliance is challenging as the two systems are inherently worn differently. As well, there is no predefined objective measure of compliance with the 4‐LB. The ACT device, worn in the IPC mode, was approximately 10% less than the time prescribed for this mode. Interestingly, the mean self‐reported wear times recorded in subject diaries for the IPC mode were exactly as instructed (2·0 hours). Similar data were obtained for the wear time in the sustained mode, in which subjects overestimated usage by about 10%. Based on the assumption that the average person sleeps about 7·5 hours per day, subject compliance with the instructed treatment was therefore approximately 71% of the instructed time.

Factors influencing patient compliance remain poorly understood 4. In a review of the literature, Moffatt et al. found the level of compliance with compression therapy in six real world studies, which used a variety of treatment modalities, ranged between 20% and 90% 3. In our study, achievement of 71% compliance is at the upper end of the Moffatt compliance data derived with use of other compression treatment modalities, many of which are not self‐applied. Thus, the ACT compliance rate documented in this current study is quite favourable.

The ability for a clinician to objectively assess usage using the automated tracking feature is a significant benefit of the ACT device. This function allows for more accurate assessment of patient use of the compressive system. In theory, these data could be used in a nurse‐managed support system to foster‐improved compliance during the treatment course and when challenges in VLU care arise.

This study demonstrated a significant improvement in the secondary outcome of QoL in favour of the ACT device, in the context of comparable outcomes for the primary efficacy outcome of wound healing. This is especially notable as these data demonstrate that ulcer healing had little effect on the observed differences in QoL. Thus, it seems likely that other product performance factors must contribute to this QoL benefit from ACT use. It is hypothesised that the improvements in QoL may arise from the same factors that drove the high level of compliance with ACT treatment. Patients would be anticipated to be able to live a more normal life when a compressive treatment permits them to apply and remove the compression device when needed. Additional factors such as reduction in ulcer pain, ease of use and improved skin protection/exudate management likely also factor into improved QoL.

Study limitations

There was a difference in the randomisation between the two treatment groups. A total of 38 subjects were enrolled into the ACT treatment group while 52 subjects were enrolled into the 4‐LB treatment group, a difference of 14 subjects. Two potential reasons for this imbalance in treatment allocation are postulated, the first being that the randomisation schedule had four separate stratification groups defined by two levels of ulcer size and two levels of ulcer duration. Any randomisation with four strata has the potential for imbalance of at least four subjects. The second potential reason for the imbalance in randomisation is that the schedule was produced with a blocking factor of 5 as the initial plan was to enrol 10 subjects per centre. However, four centres enrolled only one subject into a particular group, three centres into the 4‐LB group and one centre into the ACT group. Given that it is plausible that the imbalance occurred partly as a result of chance itself, and due to the complex nature of the randomisation stratification and under enrolment by four of the centres, it was determined that additional statistical measures were not necessary to compensate for the imbalance.

Although the 4‐LB kits were applied by trained health professionals, the lack of pressure measurement in the compression application may also be a limitation as it is unknown whether target pressures were achieved. It is important to note however that the average clinician does not, nor have the means to, measure interface pressure and therefore relies on product effectiveness when used according to manufacturer instructions rather than experts in an experimental setting.

Finally, the study was not designed to collect prospective health economic data. As the two treatments were comparable in the primary efficacy outcome of ulcer healing, other factors such as patient preference, ease of use, comfort, QoL and presumed improved health economics of use may be considered key factors that would permit application of effective compression, with a high degree of adherence, and with a higher QoL and functional independence. A key factor to consider is durability of the modality. Multi‐component compression kits are typically applied by a clinician and need to be discarded and replaced frequently. Pneumatic devices such as the ACT are provided at a higher one‐time purchase price but are durable equipment with a life expectancy of many years. In addition, they can be applied by the patients themselves without costly assistance from health professionals. Future studies are needed to prospectively evaluate the relative health economic impact of the two compression modalities.

Conclusion

This study provides evidence that ACT is an effective, safe and well‐tolerated treatment modality for VLU care. These data demonstrate a comparable degree of effectiveness for VLU healing for the traditional four‐layer compression bandage system and the new ACT system. This study also demonstrates that ACT is better accepted by the patient as it empowers them with more control of their own therapy and rewards them with the ability to remove the device as needed to enjoy key activities of daily living and personal hygiene, such as bathing and sleeping. Thus, these data demonstrate that patients treated with ACT exhibit statistically greater improvements in QoL with comparable ulcer healing to that of four‐layer bandage compression therapy.