Compression wraps (CW) are unlikely to reduce time to venous leg ulcer healing compared to two-layer bandage or evidence-based compression, and these findings may not support CW as a first line strong compression treatment for venous leg ulcers.
Key Findings
Results
Two-layer bandage was noninferior to evidence-based compression (EBC) for venous leg ulcer healing time under a treatment policy strategy, but not under a hypothetical strategy.
Using a treatment policy strategy (modified intention-to-treat analysis), the hazard ratio (HR) for the noninferiority comparison of EBC versus two-layer bandage was 1.01 (95% CI [0.79, 1.28]), meeting the pre-specified noninferiority margin of 1.33.
The corresponding hypothetical strategy analysis gave a HR of 1.16 (95% CI [0.86, 1.58]), which did not demonstrate noninferiority.
637 participants were randomised: CW (n=213), two-layer bandage (n=211), and EBC (n=213); 633 contributed time at risk and were included in analyses.
EBC comprised two-layer compression hosiery or four-layer compression bandages.
Results
Healing was statistically significantly slower in the compression wrap (CW) group compared to the EBC group.
HR for CW versus EBC was 0.78 (95% CI [0.61, 1.00]; p=0.046), indicating slower healing with CW.
The confidence intervals ranged from a 39% reduction in the hazard of healing to little or no difference between groups, indicating considerable statistical uncertainty.
This was a superiority comparison using a treatment policy strategy to handle key intercurrent events.
Results
Healing was also slower in the CW group compared to the two-layer bandage group, but this did not reach statistical significance.
HR for CW versus two-layer bandage was 0.79 (95% CI [0.61, 1.01]; p=0.056).
As with the EBC comparison, confidence intervals ranged from a 39% reduction in the hazard of healing to little or no difference.
Both superiority comparisons showed 'considerable statistical uncertainty.'
Results
Departures from allocated compression treatment were common across all arms, limiting the study's generalisability.
Departures from allocated compression treatment were described as 'common' and limit generalisability to settings with different adherence patterns.
These departures, combined with lower than expected ulcer healing incidence rates and slight under-recruitment, resulted in fewer healing events than required for 80% power.
The trial was pragmatic and open-label; participants and clinical staff were not blinded.
Results
Nine serious adverse events occurred during the trial, with one potentially related to treatment.
Nine serious adverse events were reported across the three arms.
One serious adverse event was potentially related to treatment; the cause of death could not be ascertained.
The trial was conducted across 33 UK primary, community, and hospital sites between 03.02.2021 and 31.08.2024.
Methods
The trial population had a mean age of 70.3 years, was predominantly male and white.
Mean age was 70.3 years (range 24.6 to 97.0 years).
55% (n=351) of participants were male.
The majority (n=606, 95%) were white.
All participants were adults with a venous leg ulcer appropriate for compression therapy.
Methods
The primary outcome was time to blind-assessed ulcer healing, defined as the date of the earliest photograph showing healing.
Healing assessment was conducted by blinded assessors using photographs.
Analyses used Cox proportional hazards regression adjusted for treatment allocation, baseline ulcer area and duration, participant age, and mobility status, with shared frailties for recruitment site.
Key intercurrent events were handled under both hypothetical and treatment policy strategies for the noninferiority comparison, and under a treatment policy strategy for superiority comparisons.
The pre-specified noninferiority margin was a HR of 1.33.
What This Means
This research studied three types of compression therapy for venous leg ulcers—compression wraps (CW), two-layer compression bandages, and evidence-based compression (EBC, which includes four-layer bandages or two-layer hosiery)—to find out which works best at helping ulcers heal. The study enrolled 637 adults across 33 UK healthcare sites and randomly assigned them to one of the three treatments, then tracked how quickly their ulcers healed. Two-layer bandages performed similarly to evidence-based compression in one type of analysis (suggesting they are 'noninferior'), though a stricter analysis was less conclusive. Compression wraps showed slower healing compared to evidence-based compression in a statistically significant result, and also trended toward slower healing compared to two-layer bandages, though that comparison was not statistically significant.
However, the results come with important caveats. Many participants did not stick with their assigned treatment, which makes it harder to draw firm conclusions. The study also enrolled slightly fewer participants than planned and saw fewer ulcer healings than expected, meaning it had less statistical power than intended. The confidence intervals for the key comparisons were wide, spanning from compression wraps being meaningfully worse to there being little difference between groups.
This research suggests that compression wraps are unlikely to speed up venous leg ulcer healing compared to other strong compression options, and may in fact be slower. The authors note these findings may not support compression wraps as a first-line treatment for venous leg ulcers, though some uncertainty remains due to the study's limitations. For people with venous leg ulcers and clinicians who treat them, this adds to the evidence base for choosing between compression options, while highlighting that real-world treatment adherence plays an important role in outcomes.