A Randomized, Open-Label Trial Evaluating the Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing Compared to Matched Historical Controls Receiving Standard of Care

Inclusion Criteria. 1. Patient has signed the informed consent form. 2. Male or female patient at least 18 years of age or older, as of the date of the screening visit. 3. Confirmed diagnosis of Type 1 or Type 2 DM. 4. Has a DFU that is located below the malleoli ranging in size from 1.0 cm2 to 20.0 cm2, post debridement, when measured by the investigator staff at the screening visit using the eKare device. 5. The DFU has been present for ≥4 weeks and ≤12 months. 6. The DFU is non-healing as defined as \<30% reduction in size in response to standard of care from Screening (Visit 1) to Study D…