Evaluating XPURT Amniotic Membrane Plus Standard Care Versus Standard Care Alone for Treating Nonhealing Pressure Ulcers in Adults

What this Trial Is About

Researchers are evaluating the use of a single-layer amniotic membrane called XPURT combined with standard care compared to standard care alone in treating nonhealing pressure ulcers. This multicenter, prospective clinical trial aims to better understand how this treatment approach may help wounds that have not healed over time, involving up to 100 participants from multiple providers. Participants receive weekly treatments, either standard care alone or standard care plus XPURT, for up to 20 weeks or until their ulcer fully closes. The standard care includes cleaning, debridement, moisture balance, off-loading, and reduction of bacterial burden. Weekly evaluations of the ulcers are conducted to monitor progress, and dressing changes happen once or twice a week depending on the study arm. During the study, participants attend weekly visits for wound assessment and treatment. Researchers measure wound closure, healing time, wound area reduction, pain levels, quality of life, adverse events, and product usage. The study continues until the ulcer closes or 20 weeks have passed, with confirmation of closure two weeks after it is first observed. Safety and healing progress are closely monitored throughout the trial.

A Multicenter, Prospective, Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care Versus Matched Controls in the Management of Nonhealing Pressure Ulcers