Trial of Dehydrated Human Amnion/Chorion Membrane (dHACM) In the Management of Diabetic Foot Ulcers

Inclusion criteria

• Male or female age 18 or older.
• The patient is willing and able to provide informed consent and participate in all procedures and follow up evaluations necessary to complete the study.
• Patient's ulcer must be diabetic in origin with a size ranging from 1 to 25 cm2. Debridement will be done prior to randomization, if clinically indicated.
• Wounds should be diabetic foot ulcers located on the dorsal or plantar surface of the foot.
• Patients with Type 1 or 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
• Ulcer must be present for a minimum of 30 days before enrollment/randomization, with documented failure of prior treatment to heal the wound (≤25% wound area reduction after 14 consecutive days of therapy immediately prior to randomization when treated with standard protocol of care).
• Affected leg has been offloaded (removable walker or total contact cast) for >14 consecutive days prior to randomization.
• Serum Creatinine less than 3.0mg/dl (within last 6 months).
• HbA1c less than 12% within previous 60 days.
• Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:

• Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg, OR
• ABIs with results of ≥0.7 and ≤1.2, OR
• Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected foot.
• Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).

Exclusion criteria

• Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive probe-tobone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
• Patients with multiple wounds on the same foot where other wounds are within 3 cm of the wound under care.
• Patients considered not in reasonable metabolic control, confirmed by an HbA1c 12% or greater at any time within previous 60 days.
• Known history of poor compliance with medical treatments.
• Patients currently enrolled in this study. Concurrent enrollment in the study is prohibited.
• Patients treated with investigational drug(s) or therapeutic device(s) within 30 days.
• Patients currently receiving radiation therapy or chemotherapy.
• Known or suspected local skin malignancy to the index diabetic ulcer.
• Patients diagnosed with autoimmune connective tissue diseases.
• Non-revascularizable surgical sites.
• Active infection at index site or currently being treated with antibiotics
• Any pathology that would limit the blood supply and compromise healing.
• Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days. Study ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days.
• Patients who are known to be pregnant, plan to become pregnant, or are breast feeding.
• Known allergy to Gentamicin sulfate or Streptomycin sulfate.
• Active Charcot deformity or major structural abnormalities of the foot.
• Wounds that are greater than one year in duration without intermittent closure.