Feasibility Study of DermGEN for Diabetic Foot Ulcer Treatment

Exclusion Criteria

• •1. Evidence of gangrene on affected foot.
• •2. Ulcer is over Charcot deformity (fractures or dislocation).
• •3. Ulcer is non-diabetic in etiology.
• •4. Ulcer has tunnels or sinus tracts that cannot be completely debrided.
• •5. Medical condition(s) that in the Investigator's opinion make the patient inappropriate for study
• •6. Patient has/had malignant disease not in remission for 5 years or more
• •7. Patient has acute or chronic hepatitis, cirrhosis, serum albumin \<2.0 gm/dL, or has alkaline phosphatase or LDH at twice the normal upper limit
• •8. Patient receiving oral or parenteral corticosteroids, immunosuppression or cytotoxic agents, or is anticipated to require such agents during study
• •9. Patient received radiation therapy within 30 days of Day 0 of study
• •10. Patient has AIDS or is infected with HIV
• •11. Patient has participated in another study using investigational drug(s) or device within the previous 30 days
• •12. Obvious clinical signs and symptoms of ongoing cellulitis or osteomyelitis
• •13. Patient has any other condition which seriously compromises their ability to complete the study
• •14. Patient has known allergies to antibiotics, such as penicillin and streptomycin
• •15. Patient has a history of bleeding disorder
• •16. Patient received elective osseous procedures to the study foot within 30 days prior to screening visit, except that patients whose DFU overlies an area of treated osteomyelitis may be included, providing there exists a suitable base for application of the DermGEN.