Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers
This is a clinical research study of an experimental topical drug for the treatment of chronic, neuropathic, diabetic foot ulcers.
Patients participating in the study may receive an active drug (MRE0094), inactive drug (placebo), or a gel used to treat diabetic foot ulcers currently available for sale in the United States. What treatment a patient will receive is determined by chance (like drawing a number from a hat). All patients will receive additional care for diabetic foot ulcers during the study.
Participation in the study can be up to 4½ months.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
- Incidence of complete healing of target ulcer at endpoint or 90 days, whichever is earlier.
- Time to closure and percent reduction in surface area of the target ulcer.
- Incidence, intensity, and seriousness of adverse events. Changes in irritation scores.
|Study Start Date:||December 2005|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
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