Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)

Eligibility Criteria

• 1. Known life expectancy of \< 6 months.
• 2. Target ulcer is not secondary to diabetes.
• 3. Target ulcer is infected or there is cellulitis in the surrounding skin.
• 4. Evidence of osteomyelitis complicating the target ulcer.
• 5. Infection in the target ulcer or a location that requires systemic antibiotic therapy.
• 6. Receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
• 7. Topical application of steroids to the ulcer surface within one month of screening.
• 8. Previous partial amputation on the affected foot if the resulting deformity impedes proper offloading of the target ulcer.
• 9. Surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to screening visit ("historical" run-in period). Photographic planimetry is not required for measurements taken during the historical run-in period (e.g. calculating surface area using length x width is acceptable).
• 10. Mini Nutritional Assessment (MNA) score of less than 17.
• 11. Acute Charcot foot or an inactive Charcot foot that impedes proper offloading of the target ulcer.
• 12. Women of childbearing potential (WOCBP) who are pregnant, considering becoming pregnant within the next 4 months, or are unwilling to use an appropriate form of contraception.
• 13. Currently require dialysis or planning to start dialysis.
• 14. Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments.
• 15. Treated with hyperbaric oxygen therapy or a dehydrated human placental tissue (dHTP) in the 30 days prior to screening visit.
• 16. Known sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.
• 17. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.