Safety and Early Effectiveness of TrophiPatch, a Donor Fat Cell Patch, for Treating Chronic Diabetic or Venous Leg Ulcers in Adults

What this Trial Is About

Researchers are evaluating the safety and preliminary effectiveness of an experimental biological dressing called TrophiPatch, designed for adults with chronic leg ulcers caused by diabetes or vascular problems. TrophiPatch contains stromal cells taken from donor fat tissue, which have properties that may support wound healing, reduce inflammation, and improve blood flow. This early phase study involves 18 participants and aims to assess how well the treatment is tolerated and its initial effects on wound healing. Each participant will receive a single application of the TrophiPatch directly on their ulcer. The study involves only one treatment group with no placebo comparison. The total duration of the study is up to 24 weeks, during which participants will have 23 scheduled visits for follow-up and monitoring. The treatment process focuses on one target ulcer per participant, usually the largest or most significant. During the study, participants will be closely monitored through regular visits that assess safety and track changes in the ulcer. Researchers will measure outcomes such as safety events at 12 weeks, wound healing progress, infection signs, scar formation, pain levels, blood flow quality, and quality of life. Blood tests will be done to check for immune reactions, and questionnaires will evaluate patient benefits. This detailed follow-up helps understand the treatments effects and any side effects over the 24-week period.

Safety and Preliminary Efficacy of TrophiPatch, an Adipose-Derived Stromal Cell Patch for Chronic Leg Ulcers