Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers
NCT ID: NCT00318214
Last Updated: 2012-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
16 participants
INTERVENTIONAL
2006-06-30
2008-02-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
MRE0094
Gel, 500 mcg/g once each day
2
Vehicle gel
Gel administered once per day
Interventions
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MRE0094
Gel, 500 mcg/g once each day
Vehicle gel
Gel administered once per day
Eligibility Criteria
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Inclusion Criteria
* Have type 1 or type 2 diabetes mellitus.
* Have problems with the nerves in their feet.
* Have a large ulcer or multiple ulcers on the bottom surface of their foot that has been present for 3 weeks or more and is of sufficient size to qualify for the study.
* Be able to apply study drug to their ulcer, or have a caregiver do it.
* Be able to visit the doctor regularly during the 4½ month study.
Exclusion Criteria
* Their ulcer is caused by bad blood flow to their foot.
* Their ulcer is infected.
* They cannot wear an off-loading device during the study to take pressure off the ulcer.
* They have certain other diseases, or are using certain types of drugs.
18 Years
85 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Robert L. Rolleri, Pharm.D.
Role: STUDY_DIRECTOR
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Locations
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Associated Foot & Ankle Specialists, LLC
Phoenix, Arizona, United States
Southern Arizona VA Health Care System
Tucson, Arizona, United States
Roy O. Kroeker, DPM
Fresno, California, United States
Innovative Medical Technologies
Los Angeles, California, United States
Diabetic Foot & Wound Center
Denver, Colorado, United States
North American Center for Limb Preservation
New Haven, Connecticut, United States
Karr Foot & Leg Centers
Lakeland, Florida, United States
University of Miami
Miami, Florida, United States
Ankle and Foot Specialist of Atlanta
Lithonia, Georgia, United States
Foot Healthcare Associates
Livonia, Michigan, United States
Northern Michigan Hospital
Petoskey, Michigan, United States
North Shore Podiatry Group
Port Jefferson Station, New York, United States
Calvary Hospital
The Bronx, New York, United States
UNC Wound Care Clinic
Durham, North Carolina, United States
Eastern Carolina Foot & Ankle Specialists
Greenville, North Carolina, United States
Lehigh Valley Podiatry Associates
Allentown, Pennsylvania, United States
Limb Salvage Center
Dallas, Texas, United States
Southwest Regional Wound Care
Lubbock, Texas, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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MRE0094P-202
Identifier Type: -
Identifier Source: org_study_id
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