Study of Amniotic Membrane Graft in the Management of Diabetic Foot Ulcers

Exclusion Criteria

• •1. Patients presenting with an ulcer probing to tendon, muscle, capsule or bone (UT Grade IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
• •2. Patients whose index diabetic foot ulcers are greater than 25 cm2.
• •3. Patients considered not in reasonable metabolic control, confirmed by an HbA1c greater than 12% within previous 90 days.
• •4. Patients whose serum creatinine levels are 3.0mg/dl or greater within the last six months.
• •5. Patients with a known history of poor compliance with medical treatments.
• •6. Patients who have been previously randomized into this study, or are presently participating in another clinical trial.
• •7. Patients who are currently receiving radiation therapy or chemotherapy.
• •8. Patients with known or suspected local skin malignancy to the index diabetic ulcer.
• •9. Patients diagnosed with autoimmune connective tissues diseases.
• •10. Non-revascularizable surgical sites.
• •11. Active infection at site.
• •12. Any pathology that would limit the blood supply and compromise healing.
• •13. Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days.
• •14. Patients who are pregnant or breast feeding.
• •15. Patients who are taking medications that are considered immune system modulators which could affect graft incorporation.
• •16. Patients with known hypersensitivity to components of any treatment used in the trial.
• •17. Wounds greater than one year in duration without intermittent healing.
• •18. Wounds improving greater than 20% over the first two weeks (run-in period) of the trial using standard of care dressing and camboot.
• •19. Patients taking Cox-2 inhibitors.