Dehydrated Human Amnion Membrane and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers

Exclusion Criteria

• •The subject must consent to using the prescribed offloading method for the duration of the study.
• •The subject must agree to attend the weekly study visits required by the protocol.
• •The subject must be willing and able to participate in the informed consent process.
• •A subject known to have a life expectancy of \< 6 months is excluded.
• •The subject is excluded if the target ulcer is not secondary to diabetes.
• •If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
• •If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.
• •A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
• •A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
• •The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
• •A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
• •The subject is excluded if the surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial 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).
• •The subject is excluded if the surface area measurement of the Target ulcer decreases by 20% or more during the 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1/randomization visit, during which time the subject received SOC.
• •A subject is excluded if they are malnourished: a score of less than 17 on the Mini Nutritional Assessment (MNA).
• •A Subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.
• •Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
• •A potential subject with end stage renal disease requiring dialysis is excluded.
• •A subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
• •A Subject treated with hyperbaric oxygen therapy or a Cellular Acellular, or Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit is excluded.