Study Comparing Matrion Placental Membrane Treatment to Standard Care for Diabetic Foot Ulcers in Adults

What this Trial Is About

Researchers are evaluating Matrion, a placental membrane product derived from donated human birth tissue, as a treatment for diabetic foot ulcers DFU. This study compares Matrion to conventional wound care, focusing on healing outcomes for ulcers in adults aged 21 to 80 years with type I or type II diabetes. Matrion is processed to be acellular and sterile, making it suitable for surgical use in treating wounds. Participants will be randomly assigned to receive either Matrion graft application or conventional wound management. The Matrion graft is applied to the cleaned ulcer and secured, potentially repeated weekly, along with standard dressings and off-loading. The conventional care group will receive moist wound therapy with appropriate gauze dressings changed every 5 to 9 days and off-loading support. Both groups will be monitored over a 12-week period to assess wound healing. During the study, participants will attend regular visits for wound assessment including size, depth, and healing progress. Researchers will track wound closure rates, infection, recurrence, and any adverse events related to treatments. The main outcome is wound healing at 12 weeks, with follow-up evaluations including speed of closure and graft use. Participants must comply with dressing changes and off-loading requirements and will be monitored for safety throughout the trial, which is expected to end by June 2026.

Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers