A Multicenter, Adaptive Design, Randomized, Single-Blind Study with an Open-Label Extension to Further Evaluate the Safety and Efficacy of Grafix(RegisteredTM) for the Treatment of Chronic Diabetic Foot Ulcers (Protocol 302)
Approximately 266 patients (final number will be determined via interim analysis) will receive either Grafix or a control dressing for a chronic diabetic foot ulcer that is between 1 cm and 15 cm square. Since this is an adaptive design trial, the final sample size may increase based on the interim analysis for re-powering the study sample size.
Patients will be randomly assigned to the two groups and will be assigned in a 1:1 ratio to those who receive Grafix versus those who receive a non-adherent control dressing. Patients will receive treatment every week for up to 12 weeks duration in the Single-Blind Treatment phase of the trial.
1. Between 18 years and 80 years of age inclusive, as of the date of screening
2. Confirmed diagnosis of Type I or Type II Diabetes
3. An Index Ulcer defined as chronic (present of wound for > or = 4 weeks) but not present for more than 52 weeks at the Screening Visit
4. Index Ulcer is located below the malleoli on the plantar or dorsal surface of the foot
5. The Index Ulcer is between 1 and 15 cm. squared at the Screening Visit
6. The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule
7. Wound is free of necrotic debris
8. Patient has adequate circulation to the foot as documented by testing