SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II)

This study is a prospective, multi-center, randomized controlled trial (RCT) designed to assess the safety and efficacy of SkinTE with standard of care (SOC) dressings compared to SOC dressings alone (wound debridement, silicone dressing, multi-layer compression dressings, and offloading) in the treatment of Wagner grade 1 diabetic foot ulcers (DFUs) ranging in size from 1 to 15 cm2. After being informed about the study and potential risks, all patients giving written informed consent who meet eligibility criteria will undergo a 2-week screening period of SOC. Patients meeting eligibility criteria following the screening period will be randomized in a single-blind manner (closure confirmed by 3 blinded adjudicators) in a 1:1 ratio to SkinTE with SOC or SOC alone. Patients will be followed weekly for 6 months for wound closure.