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Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers


Pivotal Study to Evaluate the Efficacy and Safety of Dermal-Living Skin Replacement (Dermal-LSR) in the Treatment of Chronic Diabetic Foot Ulcers




The purpose of this study is to determine the safety and efficacy of Dermal-LSR plus Standard of Care (SOC) for the treatment of diabetic foot ulcers (DFU)in comparison to the treatment to SOC alone.

Study Status: Terminated


Condition Intervention Phase
Diabetic Foot Ulcer Device: Dermal - Living Skin Replacement (Dermal - LSR) Phase 3

Verified by ApoPharma April, 2008

Sponsored by: ApoPharma
Information provided by: ApoPharma identifier: NCT00387101

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

The Learner Research Centre, Department of Orthopaedic Surgery. The Cleveland Clinic Foundation, 9500 Euclid Ave. A40
Cleveland, Ohio 44195
United States

Jason R Hanft, DPM, FAC FAS., Principal Investigator
Hau Pham, DPM., Principal Investigator
Rodney Stuck, DPM., Principal Investigator
Vickie Driver, DPM., Principal Investigator
Zevi Isseroff, DPM., Principal Investigator
Lowell Weil, Jr., DPM, MBA, FAC FAS., Principal Investigator
Michal Drews., Principal Investigator
Henryk Komon., Principal Investigator
Krystyna Pilarska., Principal Investigator
Malgorzata Wilczynska., Principal Investigator
Joseph Cavorsi, M.D.., Principal Investigator
Roslyn R Isseroff, M.D.., Principal Investigator
Georgeanne Botek, DPM., Principal Investigator
Adam Landsman, DPM, PhD., Principal Investigator
Jodi Walters, DPM., Principal Investigator
Martin Taubman, DPM., Principal Investigator

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