Study:
Pivotal Study to Evaluate the Efficacy and Safety of Dermal-Living Skin Replacement (Dermal-LSR) in the Treatment of Chronic Diabetic Foot Ulcers
Rationale:
n/a
Purpose:
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
Recruiting:
n/a
| 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
ClinicalTrials.gov 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