IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers

Exclusion criteria

• . The potential subject is known to have a life expectancy of \<6 months.
• . Index Ulcers will be excluded if they meet any of the following criteria upon assessment:
• . The target ulcer exhibits 2 or more of the following signs or symptoms consistent with clinical infection:
• . Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator\'s exam or radiographic evidence.
• . The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent), radiation therapy, cytotoxic chemotherapy, or is taking medications that the Principal Investigator believes will interfere with wound healing (e.g., biologics).
• . The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
• . The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
• . The surface area of the target ulcer, as measured by digital planimetry or manual linear measurements (e.g. with a ruler), decreases by more than 25% in the 2 weeks prior to the initial screening visit ("historical" run-in period).