a Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers
brief summary
BIOxHEAL is an investigational biologic made from donated human amniotic membrane, placed directly on the wound to help it heal. Adults with type 1 or type 2 diabetes who have a foot ulcer that has not healed with standard wound care may be able to join. Participants are assigned by chance to one of two groups: BIOxHEAL plus standard wound care, or standard wound care alone. Both groups visit the clinic once a week for up to 12 weeks, or until the ulcer has fully closed. The main question is whether more ulcers close completely by Week 12 when BIOxHEAL is added to standard care
detailed description
Phase 3, multicenter, prospective, open-label, randomized controlled study at up to 30 U.S. centers. A non-randomized sentinel cohort (5 completed participants required, up to 10 enrolled) first receives BIOxHEAL plus standard of care (SOC) to assess early safety. After Data and Safety Monitoring Board (DSMB) review and FDA approval, 243 participants are randomized 2:1 to BIOxHEAL plus SOC or SOC alone, stratified by baseline ulcer area and ulcer duration. Treatment is given weekly for up to 12 weeks or until complete ulcer closure, which is confirmed 2 weeks later, followed by 3 months of follow-up.
official title
a Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Biologic and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers.