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Sponsored by: |
King Pharmaceuticals Research and Development |
Information provided by: | King Pharmaceuticals Research and Development |
ClinicalTrials.gov Identifier: | NCT00318214 |
This is a clinical research study of an experimental topical drug for the treatment of chronic, neuropathic, diabetic foot ulcers. The purpose of the study is to determine the safety of the experimental drug when applied to large, diabetic foot ulcers. The study will also determine if the experimental drug can safely promote healing of diabetic foot ulcers better than standard treatments currently available to doctors.
Patients participating in the study may receive an active drug (MRE0094) or inactive drug (placebo). 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 |
Foot Ulcer, Diabetic Diabetes Complications |
Drug: MRE0094 Drug: Vehicle gel |
Phase II |
MedlinePlus related topics: | Diabetes Diabetes Complications Diabetic Foot Foot Health |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Enrollment: | 16 |
Study Start Date: | June 2006 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: MRE0094
Gel, 500 mcg/g once each day
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2: Placebo Comparator |
Drug: Vehicle gel
Gel administered once per day
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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:
United States, Arizona | |||||
Associated Foot & Ankle Specialists, LLC | |||||
Phoenix, Arizona, United States, 85015 | |||||
Southern Arizona VA Health Care System | |||||
Tucson, Arizona, United States, 85723 | |||||
United States, California | |||||
Innovative Medical Technologies | |||||
Los Angeles, California, United States, 90063 | |||||
Roy O. Kroeker, DPM | |||||
Fresno, California, United States, 93710 | |||||
United States, Colorado | |||||
Diabetic Foot & Wound Center | |||||
Denver, Colorado, United States, 80220 | |||||
United States, Connecticut | |||||
North American Center for Limb Preservation | |||||
New Haven, Connecticut, United States, 06515 | |||||
United States, Florida | |||||
Karr Foot & Leg Centers | |||||
Lakeland, Florida, United States, 33813 | |||||
University of Miami | |||||
Miami, Florida, United States, 33136 | |||||
United States, Georgia | |||||
Ankle and Foot Specialist of Atlanta | |||||
Lithonia, Georgia, United States, 30058 | |||||
United States, Michigan | |||||
Foot Healthcare Associates | |||||
Livonia, Michigan, United States, 48152 | |||||
Northern Michigan Hospital | |||||
Petoskey, Michigan, United States, 49770 | |||||
United States, New York | |||||
Calvary Hospital | |||||
Bronx, New York, United States, 10461 | |||||
North Shore Podiatry Group | |||||
Port Jefferson Station, New York, United States, 11776 | |||||
United States, North Carolina | |||||
Eastern Carolina Foot & Ankle Specialists | |||||
Greenville, North Carolina, United States, 27834 | |||||
UNC Wound Care Clinic | |||||
Durham, North Carolina, United States, 27713 | |||||
United States, Pennsylvania | |||||
Lehigh Valley Podiatry Associates | |||||
Allentown, Pennsylvania, United States, 18104 | |||||
United States, Texas | |||||
Limb Salvage Center | |||||
Dallas, Texas, United States, 75231 | |||||
Southwest Regional Wound Care | |||||
Lubbock, Texas, United States, 79410 | |||||
United States, Wisconsin | |||||
St. Luke's Medical Center | |||||
Milwaukee, Wisconsin, United States, 53215 |
King Pharmaceuticals Research and Development |
Study Director: | Robert L. Rolleri, Pharm.D. | King Pharmaceuticals |
Responsible Party: | King Pharmaceuticals, Inc. ( Eric G. Carter, Ph.D., M.D., Chief Science Officer ) |
Study ID Numbers: | MRE0094P-202 |
First Received: | April 24, 2006 |
Last Updated: | March 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00318214 |
Health Authority: | United States: Food and Drug Administration |
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