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

Exclusion Criteria

• •1. 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.
• •2. Patients with multiple wounds on the same foot where other wounds are within 3 cm of the wound under care.
• •3. Patients considered not in reasonable metabolic control, confirmed by an HbA1c 12% or greater at any time within previous 60 days.
• •4. Known history of poor compliance with medical treatments.
• •5. Patients currently enrolled in this study. Concurrent enrollment in the study is prohibited.
• •6. Patients treated with investigational drug(s) or therapeutic device(s) within 30 days.
• •7. Patients currently receiving radiation therapy or chemotherapy.
• •8. Known or suspected local skin malignancy to the index diabetic ulcer.
• •9. Patients diagnosed with autoimmune connective tissue diseases.
• •10. Non-revascularizable surgical sites.
• •11. Active infection at index site or currently being treated with antibiotics
• •12. Any pathology that would limit the blood supply and compromise healing.
• •13. 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.
• •14. Patients who are known to be pregnant, plan to become pregnant, or are breast feeding.
• •15. Known allergy to Gentamicin sulfate or Streptomycin sulfate.
• •16. Active Charcot deformity or major structural abnormalities of the foot.
• •17. Wounds that are greater than one year in duration without intermittent closure.