Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers

Inclusion Criteria

• •1. Medicare/Medicaid eligible
• •2. ≥18 years of age
• •3. Type I or II diabetes requiring medical treatment as determined by the physician
• •4. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) is a Wagner 1-5 DFU (see Appendix 9 for Wagner Classification) that is located on the dorsal, plantar, medial, or lateral aspect of the foot or heel (including all toe surfaces)
• •5. For subjects with potentially multiple eligible DFUs, the largest ulcer will be selected There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure)
• •6. Debrided ulcer size between 0.5 cm2 and 50 cm2
• •7. Demonstrated adequate offloading regimen
• •8. Duration ≥ 1 month at first visit
• •9. Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician.