Use of AC5® Advanced Wound System in the Treatment of Diabetic Foot Ulcers

Inclusion Criteria

• •1. Males and females aged 18 or older.
• •2. Subject is willing to sign informed consent and participate in all procedures with follow up evaluations as necessary to complete the study.
• •3. Study ulcer is diabetic in origin, located on the foot or below the malleolus with ulcer extending through the dermis but not into tendon, muscle or bone (UT Grade 1A).
• •4. Study ulcer size is a minimum of 2 cm2 and maximum 25 cm2 after the run-in period.
• •5. Study ulcer has been present for a minimum of 4 weeks before enrollment and less than 1 year old, with documented failure of prior treatment to heal the wound.
• •6. Study ulcer has been offloaded for at least 14 days prior to randomization.
• •7. A two-week run-in period will precede enrollment in the trial to document the indolent nature of the subjects selected; healing rate is not to be \> 40% during this period.
• •8. Subject does not exhibit clinical signs / symptoms of infection upon gross observation or have been diagnosed with an active infection at time of screening.
• •9. Subject has adequate control of diabetes demonstrated by Hemoglobin A1c \< 12% within 90 days of screening.
• •10. Subject has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days of the first screening visit:
• •* Dorsal transcutaneous oxygen measurements (TCOM) ≥ 30mmHg.
• •* Ankle-Brachial Index with results of ≥ 0.8 and ≤ 1.5 or had past intervention.