Clinical Study to Compare Two Skin Substitute Categories for Their Effectiveness to Treat Diabetic Foot Ulcers

Exclusion Criteria

• •9. The subject must consent to using the prescribed off-loading method for the duration of the study.
• •10. The subject must agree to attend the twice-weekly/weekly study visits required by the protocol.
• •11. The subject must be willing and able to participate in the informed consent process.
• •12. Patients must have read and signed the IRB approved ICF before screening procedures are undertaken.
• •1. A subject known to have a life expectancy of \< 6 months.
• •2. If the target ulcer is infected or if there is cellulitis in the surrounding skin.
• •3. Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
• •4. A subject has an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
• •5. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy.
• •6. Topical application of steroids to the ulcer surface within one month of initial screening.
• •7. A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
• •8. A subject with a glycated hemoglobin (HbA1c) greater than or equal to 13% taken at or within 3 months of the initial screening visit.
• •9. A subject with a serum creatinine ≥ 3.0mg/dL within 6 months of the initial screening visit.
• •10. A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer.
• •11. Women who are pregnant or considering becoming pregnant within the next 6 months.
• •12. A subject with end stage renal disease requiring dialysis.
• •13. A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
• •14. A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.
• •15. A subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit.
• •16. A subject who has a sensitivity to bovine (cattle) or ovine (sheep) material.
• •17. A subject that is allergic to aminoglycoside antibiotics (gentamycin, tobramycin, etc.)