A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers

What this Trial Is About

Researchers are evaluating the effectiveness of adding Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial PCMP to standard care compared to standard care alone for people with chronic diabetic foot ulcers DFUs. This prospective, multi-center, randomized, controlled trial aims to better manage nonhealing DFUs by comparing different wound treatment methods. The study is sponsored by Organogenesis and focuses on wound healing outcomes over a 12-week period. Participants will be randomly assigned to one of three groups standard of care SOC alone, PuraPly Antimicrobial Wound Matrix PuraPly AM plus SOC, or PuraPly Antimicrobial XT Wound Matrix PuraPly XT plus SOC. The PuraPly devices are collagen-based wound matrices coated with an antimicrobial agent called polyhexamethylenebiguanide hydrochloride PHMB. Following screening, subjects will attend weekly visits for up to 12 weeks where treatments and healing progress will be monitored. Those who heal will have a confirmation visit two weeks later to ensure wound closure is maintained. During the study, participants will undergo regular assessments including wound measurements and evaluations of healing progress. Researchers will monitor the time to complete closure, the percentage reduction in wound area, and record any adverse events during the 12-week treatment period. The study involves weekly visits and requires participants to follow prescribed offloading methods for the foot ulcer. The overall goal is to determine if these antimicrobial collagen matrices improve healing compared to standard wound care alone.

A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers