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

Eligibility 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.
• 1. Study ulcer wound surface is area greater than 25 cm2.
• 2. Study ulcer has \> 40% wound healing during the 14 days screening period.
• 3. Subject has a known history of poor compliance with medical treatments.
• 4. Subject is presently participating in another clinical trial.
• 5. Subject has a known or suspected local malignancy to the Study diabetic ulcer, or systemic malignancy.
• 6. Subject has been diagnosed with autoimmune connective tissues diseases.
• 7. Subject has received graft material or topical growth factors on the study ulcer within the previous 30 days.
• 8. Subject has received application of topical steroids on the study ulcer surface within the previous 30 days.
• 9. Subject is pregnant or breast feeding.
• 10. Subject is on dialysis.
• 11. Subject is taking medications that are considered immune system modulators or cytotoxic chemotherapies.
• 12. Subject cannot be on systemic antibiotics prior to randomization, however, during the treatment phase infection management may include systemic antibiotics if in conjunction with debridement.
• 13. Subject has a known allergy to ingredients/components of AC5.
• 14. Subject has osteomyelitis, and/or bony prominences present in the wound.
• 15. Subject has ulcer probing to bone and tendon. (UT Grade II or III A-D).
• 16. Subject is unable to comply with planned study procedures and treatments.