Hypothermically stored amniotic membrane compared to standard of care for complex venous leg ulcers: a randomised...

Venous leg ulcers (VLUs) are prevalent hard-to-heal (chronic) wounds that decrease quality of life due to pain, reduced function and economic burden. One advanced therapy or cellular, acellular and matrix-like product (CAMP) which serves as a protective barrier for the management of acute and hard-to-heal wounds is a hypothermically stored amniotic membrane (HSAM). The objective of this study was to assess the clinical effectiveness and safety of HSAM plus standard of care (SoC) compared to SoC alone for the management of challenging and complex VLUs.

This prospective, multicentre, randomised controlled trial (RCT) evaluated patients over 24 weeks after a four-week run-in period. Endpoints included: frequency of wound closure of cohorts stratified by wound duration (>6 and >24 months); and intent-to-treat (ITT) population wound improvements of >60% area, >50% depth and >75% volume reduction.

The experimental cohort comprised 206 patients (randomised 1:1 to HSAM+SoC or SoC alone). Patient baseline demographics and wound characteristics were comparable between groups. The HSAM+SoC group demonstrated significantly higher rates of wound closure at weeks 12 and 16 (p<0.05) across both wound duration strata. In the ITT population, the HSAM+SoC group achieved significantly greater incidences of reduction in wound area (p=0.036), depth (p<0.001) and volume (p=0.034) compared to SoC alone.

In this study, HSAM+SoC was shown to be effective in the most challenging and complex VLUs, with increased wound closure rates compared to SoC alone when stratified by wound duration. These findings, alongside diabetic foot ulcer RCT results, provide compelling evidence for the significant clinical benefit of HSAM for hard-to-heal wounds.