A Prospective, Multicenter, Randomized, Controlled Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM
This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amniotic Membrane (BR-AM) plus standard of care versus standard of care only in the treatment of diabetic foot ulcers. The trial design will control potential variables that may affect the outcome between the treatment group and the control group by standardizing the requirements for debridement, wound dressings, and offloading. Weekly subject visits will help monitor compliance in wound care and off-loading, as well as to document when wound closure is achieved. The study will also implement the use of an electronic imaging and measurement device using a standardized protocol to ensure the measuring of the wound surface area and volume is accurate, highly reproducible, and minimally variable. There will also be a crossover treatment phase for those patients that were relegated to standard care only. After their 12-week standard of care treatment phase and for only those subjects that did not achieve complete wound closure, will be allowed to crossover for an additional 12 weeks of treatment with the BR-AM product following the protocol and procedures set forth within this document.
• Patient has signed the informed consent form.
• Male or female patient at least 18 years of age or older, as of the date of the screening visit.
• Confirmed diagnosis of Type 1 or Type 2 Diabetes.
• Has a DFU that is located below the malleoli at least 1.0 cm2 or up to 20.0 cm2 when measured by the investigator staff at the screening visit using the eKare device post debridement.
• a. If more than one ulcer is present the selected target ulcer must be at least 2 cm from the nearest edge of any adjacent ulcers.
• The depth of the target foot ulcer is graded as Wagner Grade I or II, i.e., with no evidence of exposed muscle, tendon, bone, or joint capsule.
• The target ulcer is chronic, hard-to-heal, defined as having a duration of \> 4 weeks but ≤ 52 weeks at the time of the screening visit.
• Arterial supply adequacy to the foot with the target ulcer confirmed by any one of the following:
‣ Great toe pressure ≥ 40 mm/Hg
⁃ Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.70 ≤ 1.20
⁃ TcPO2 ≥ 30 mmHg from the foot
⁃ Toe Brachial Index or TBI ≥ 0.50
• Willing to follow all instructions given by the Investigator, return for all visits, and adhere to off-loading protocols while on the study.