A Multicenter, Randomized, Controlled, Clinical Trial Evaluating a Lyopreserved Amniotic Membrane in the Treatment of Venous Leg Ulcers.

Background: Standard of Care (SoC) with multilayer compression therapy along with proper wound management, may not be sufficient to close all venous ulcers and needs advanced therapies. Methods: In this multicenter, prospective, randomized, controlled, open-label trial, 351 patients were screened, 200 were eligible and enrolled and were randomized 1:1 to LPM (lyopreserved cellular placental membrane) plus SoC or SoC alone for up to 12 weeks. Patients were enrolled between June 2018 and November 2020 at 30 sites across the United States. Outcome measures included complete closure of the index ulcer (primary), reduction in wound size, rate of closure, quality of life, and adverse events. Results: ITT analysis revealed that wounds treated with weekly applications of LPM as an adjunct to standard of care, reduced in size significantly more than SoC alone, at the end of 4, 8, and 12 graft applications, indicating a faster progression to closure. There was a statistically 1.72 higher relative risk or 72% higher probability of wound closure with LPM compared to the SoC group during the study period for wounds with an initial size of 3-25 cm Conclusion: LPM and standard of care, significantly closed more venous leg ulcers and faster than standard of care alone and improved the quality of life for patients, suggesting that the use of aseptically processed LPM is a safe and effective treatment option in the healing of chronic venous leg ulcers.