Diabetic Foot Ulcers Clinical Trial
Official title:
A Multicenter, Adaptive Design, Randomized, Single-Blind Study With an Open-Label Extension Option to Further Evaluate the Safety and Efficacy of Grafix® for the Treatment of Chronic Diabetic Foot Ulcers
The primary objective of the present study is to further establish in a randomized
controlled trial, the safety and efficacy of weekly Grafix® administration versus control in
patients with chronic diabetic foot ulcers. The primary endpoint is complete wound closure
of the index wound, defined as 100% re-epithelialization as determined by the Investigator.
Grafix® is a product regulated for use in the US by the FDA as a Human Cellular and Tissue
Based Product (HCT/P) under Title 21 CFR Part 1271.
The treatment indication is for chronic, diabetic foot ulcers (DFUs) between 1cm2 and 15cm2
located below the malleoli on the plantar or dorsal surface of the foot. Patients must have
confirmed Type I or Type II Diabetes.
Patients will receive treatment every week for 12 weeks duration in the Single-Blind
Treatment phase of the trial.
Patients who receive Grafix® or control will be evaluated for primary efficacy up to 84
days, and for safety and wound re-occurrence for 84 days after wound closure. Patients in
the control group whose wounds are not closed at the end of treatment may be offered Grafix®
in an Open-Label Treatment phase. The Open-Label Treatment phase can last up to an
additional 84 days.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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