Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers
Trial Parameters
Brief Summary
This study will evaluate Matrion™ (LifeNet Health, Inc., Virginia Beach, VA), a placental membrane product, as a treatment for diabetic foot ulcers compared to conventional wound care. Matrion is derived from donated human birth tissue and includes both the amniotic and chorionic layers, along with the trophoblast layer. It is minimally processed using a proprietary decellularization method and terminally sterilized to ensure the membrane is acellular and sterile, making it suitable for surgical applications.
Eligibility Criteria
Inclusion Criteria: To be considered eligible to participate in this study, a subject must meet the inclusion criteria listed below: 1. Be male or female and aged between 21 and 80 years at the time of informed consent 2. Have a diagnosis of Type I or Type II diabetes as defined by the American Diabetes Association and have been on a stable anti-diabetic treatment regimen for at least 30 days before the baseline visit. 3. Have full-thickness wound of the lower extremity, below the ankle 4. Have a single target ulcer 5. Have a wound with an area greater than or equal to 1cm2 and less than 25 cm2 with a depth less than or equal to 9 mm 6. Have a diabetic foot ulcer that has been present for at least 30 days with a Wagner Classification Grade 1 or 2: * Grade 1: superficial diabetic ulcer involving the full skin thickness but not underlying tissues * Grade 2: ulcer extension involving ligament, tendon, joint capsule, or fascia, without presence of abscess or osteomyelitis 7. Have an absenc