Randomized Trial of Miro3D Wound Matrix Plus Standard Care Versus Standard Care Alone for Wagner Grade 1 Diabetic Foot Ulcers and Wound Dehiscence

What this Trial Is About

Researchers are evaluating the effectiveness of Miro3D Wound Matrix combined with standard wound care compared to standard care alone in treating Wagner Grade 1 diabetic foot ulcers and wound dehiscence. Sponsored by Reprise Biomedical, Inc., this prospective, randomized controlled trial aims to determine whether adding Miro3D, a three-dimensional acellular porcine-derived wound matrix, improves early wound healing and overall outcomes in an outpatient setting. The study focuses on wound area reduction and granulation tissue formation at four weeks as predictors of healing by twelve weeks. Participants will be randomized into two groups: one receiving Miro3D plus standard of care (SOC) and the other receiving SOC alone. In the Miro3D group, the device is applied weekly for four weeks, then biweekly if needed, for up to twelve weeks. The SOC group receives usual wound care like cleansing, debridement, dressings, and offloading. If wounds remain unhealed after twelve weeks in the SOC group, participants may crossover to receive Miro3D treatment for an additional twelve weeks following the same schedule. Participants will be followed weekly for up to twelve weeks, with wound measurements, imaging, pain assessments, and quality of life evaluations at each visit. Those who heal will have confirmation visits at two and four weeks post-closure. The study will measure wound area reduction, granulation tissue, pain levels, and quality of life changes. Safety monitoring will document adverse events and device-related issues throughout, with additional observation for crossover participants. The trial aims to provide clinical evidence supporting Miro3D's role in enhancing wound healing in diabetic patients.

Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing