Dehydrated Human Amnion Membrane and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers
Trial Parameters
Brief Summary
The purpose of this study is to evaluate the efficacy of dehydrated human amnion membrane (dhAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
Eligibility Criteria
Inclusion Criteria: * Subjects must be at least 18 years of age or older. * Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus. * At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 5.0 cm2 measured post debridement. * The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit. * The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus. * The target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone. * The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable: 1. ABI ≥ 0.7 and ≤ 1.3; 2.