Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00312364|
Recruitment Status : Completed
First Posted : April 10, 2006
Last Update Posted : June 1, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Foot Ulcer, Diabetic Diabetes Complications||Drug: MRE0094||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||322 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312364