Phase 3Recruiting
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 (AB BIOH - DFU)
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.
- Sponsor
- Applied Biologics, LLC (Industry)
- Enrolment
- 253 planned
- Conditions
- Diabetic Foot Ulcer; Amniotic Membrane Placental Allograft; Biologic
- Interventions
- Standard of Care; BIOxHEAL (human amniotic membrane allograft)
- Ages
- adults, older adults
- Registry
- NCT07852338
Full record on ClinicalTrials.gov
From the registry
BIOxHEAL is an investigational placental-derived biologic being evaluated for the treatment of nonhealing diabetic foot ulcers. Adults with type 1 or type 2 diabetes who have a diabetic foot ulcer that has not healed with standard wound care may be eligible to participate. Participants in the randomized phase are assigned by chance in a 2:1 ratio to receive either BIOxHEAL administered topically in combination with standard of care (SOC), or SOC alone. Treatment is administered once weekly for up to 12 weeks or until complete ulcer closure. The primary objective is to evaluate whether BIOxHEAL plus SOC increases the proportion of target ulcers achieving complete closure at Week 12 compared with SOC alone.
Primary outcomes
- Proportion of target ulcers with complete wound closure at Week 12
History
Primary completion expected
Last registry update
Started
Registered