The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer

Exclusion Criteria

• •1. Greater than 30% reduction in wound size during first week of observation by the investigator.
• •2. Ulcer with exposed tendon or bone.
• •3. Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis.
• •4. Gangrene.
• •5. Active Charcot's disease as determined by clinical and radiographic examination.
• •6. Ulcer of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers).
• •7. Known severe anemia.
• •8. Known serum albumin \< 2.5.
• •9. Renal failure with Creatinine \> 2.5.
• •10. Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV.
• •11. Severe liver disease as defined by the treating physician or patient's primary care physician.
• •12. Malignancy at or near the ulcer site.
• •13. Any condition judged by the investigator that would cause the study to be detrimental to the patient.
• •14. Presence of a hematology, clinical, chemistry or other test obtained within 7 days of screening that is outside the normal range for the laboratory and is determined to be clinically significant by the investigator.
• •15. Received another investigational device or drug within 30 days of Day 0.
• •16. Radiation therapy, chemotherapy or immunosuppressive therapy within 30 days of enrollment.
• •17. Received another allograft, autograft or xenograft within 30 days of the Day 0.
• •18. Known allergy to equine derived tissue.
• •19. Alcohol or drug abuse, defined as current medical treatment for substance abuse.
• •20. Pregnant or nursing women.