Clinical Trial Evaluating Xcell Amnio Matrix with Standard Treatment for Diabetic Foot Ulcers in Adults

What this Trial Is About

Researchers are evaluating the clinical outcomes of treating Diabetic Foot Ulcers DFUs with a weekly application of Xcell Amnio MatrixTM XAM alongside standard care, compared to standard care alone. The study aims to find out how many participants achieve complete wound closure during a 12-week treatment phase. Participants will be adults over 18 years old with chronic non-healing DFUs that meet specific criteria related to ulcer size, duration, and health status. The study involves two groups one receiving Xcell Amnio MatrixTM plus standard care, and the other receiving only standard care chosen by the investigator. Eligible participants will receive weekly treatments with the study product for 12 weeks, returning to the clinic every 7 days 3 days for visits. After completing treatment, participants will have a follow-up visit two weeks later to assess continued healing. Participants will be screened and re-screened to confirm eligibility. Throughout the trial, researchers will monitor wound closure rates, changes in wound area, time to complete healing, and pain levels in the target ulcer using a pain rating scale. The total participation includes 12 weeks of treatment and a 2-week follow-up, with regular clinic visits to assess progress and ensure safety.

A Prospective Clinical Study to Evaluate the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) in the Management of Chronic Non-healing DFUs