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Sponsored by: |
King Pharmaceuticals Research and Development |
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Information provided by: | King Pharmaceuticals Research and Development |
ClinicalTrials.gov Identifier: | NCT00312364 |
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 | Intervention | Phase |
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Foot Ulcer, Diabetic Diabetes Complications |
Drug: MRE0094 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Enrollment: | 322 |
Study Start Date: | December 2005 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Participants included in the study must:
Exclusion Criteria:
Participants may not participate in the study if:
Study ID Numbers: | MRE0094P-201 |
Study First Received: | April 6, 2006 |
Last Updated: | January 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00312364 History of Changes |
Health Authority: | United States: Food and Drug Administration |
toe ulcer heel ulcer foot ulcer |
diabetic feet diabetic foot complications of diabetes |
Foot Ulcer Skin Diseases Diabetic Neuropathies Ulcer Diabetes Mellitus Vascular Diseases Endocrine System Diseases |
Foot Diseases Diabetic Angiopathies Endocrinopathy Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |
Foot Ulcer Diabetic Neuropathies Skin Diseases Ulcer Vascular Diseases Diabetes Mellitus Endocrine System Diseases Foot Diseases |
Diabetic Angiopathies Pathologic Processes Cardiovascular Diseases Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |