Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers
- Conditions
- Foot Ulcer, DiabeticDiabetes Complications
- Registration Number
- NCT00312364
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 322
Participants included in the study must:
- Have type 1 or type 2 diabetes mellitus.
- Have problems with the nerves in their feet.
- Have an ulcer 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.
Participants may not participate in the study if:
- Their ulcer is caused by bad blood flow to their foot.
- Their ulcer is infected.
- They cannot wear a special boot during the study to take pressure off the ulcer.
- They have certain other diseases, or are using certain types of drugs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of complete healing of target ulcer at endpoint or 90 days, whichever is earlier.
- Secondary Outcome Measures
Name Time Method Time to closure and percent reduction in surface area of the target ulcer. Incidence, intensity, and seriousness of adverse events. Changes in irritation scores.
Trial Locations
- Locations (63)
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
UCSD Wound Treatment and Research Center
🇺🇸San Diego, California, United States
Institute for Advanced Wound Care
🇺🇸Montgomery, Alabama, United States
Palo Verde Foot and Ankle
🇺🇸Bullhead City, Arizona, United States
Southern Arizona VA Health Care System
🇺🇸Tucson, Arizona, United States
Vertex Clinical Research
🇺🇸Bakersfield, California, United States
Roy O. Kroeker, DPM
🇺🇸Fresno, California, United States
Innovative Medical Technologies
🇺🇸Los Angeles, California, United States
Walter F. D'Costa, DPM
🇺🇸Santa Rosa, California, United States
North American Center for Limb Preservation
🇺🇸New Haven, Connecticut, United States
Christiana Care Health Systems Wound Care Center
🇺🇸Wilmington, Delaware, United States
Countryside Foot and Ankle Center
🇺🇸Clearwater, Florida, United States
Karr Foot & Leg Centers
🇺🇸Lakeland, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Baptist Hospital
🇺🇸Pensacola, Florida, United States
Doctor's Research Network
🇺🇸South Miami, Florida, United States
Dr. Robert J. Snyder
🇺🇸Tamarac, Florida, United States
Ankle and Foot Specialist of Atlanta
🇺🇸Lithonia, Georgia, United States
Podiatry Center of Idaho, PLLC
🇺🇸Boise, Idaho, United States
Adam S. Landsman, DPM, PhD, FACFAS
🇺🇸Highland Park, Illinois, United States
Advocate Lutheran General Hospital
🇺🇸Niles, Illinois, United States
North Chicago VA Medical Center
🇺🇸North Chicago, Illinois, United States
Thomas Kevin Brattain, DPM
🇺🇸Peoria, Illinois, United States
Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Dolby Research, LLC
🇺🇸Baton Rouge, Louisiana, United States
Welborn Clinic
🇺🇸Evansville, Indiana, United States
The Wound Healing Center
🇺🇸Terre Haute, Indiana, United States
Foot Healthcare Associates
🇺🇸Livonia, Michigan, United States
Northern Michigan Hospital
🇺🇸Petoskey, Michigan, United States
Calvary Hospital
🇺🇸Bronx, New York, United States
Foot & Ankle Physicians
🇺🇸Union, New Jersey, United States
Upstate Clinical Research Associates
🇺🇸Williamsville, New York, United States
St. John's Queens Hospital
🇺🇸Elmhurst, New York, United States
North Shore Podiatry Group
🇺🇸Port Jefferson Station, New York, United States
Eastern Carolina Foot & Ankle Specialists
🇺🇸Greenville, North Carolina, United States
Austintown Podiatry Associates, Inc.
🇺🇸Austintown, Ohio, United States
Optimed Research, LLC
🇺🇸Columbus, Ohio, United States
Advanced Regional Center for Ankle and Foot Care
🇺🇸Altoona, Pennsylvania, United States
Lehigh Valley Podiatry Associates
🇺🇸Allentown, Pennsylvania, United States
UPMC Horizon
🇺🇸Farrell, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Foot and Ankle Institute
🇺🇸Philadelphia, Pennsylvania, United States
Prigoff-Bowers, LLP
🇺🇸Dallas, Texas, United States
Limb Salvage Center
🇺🇸Dallas, Texas, United States
South Texas Foot Institute
🇺🇸Floresville, Texas, United States
Memorial Hermann Wound Center
🇺🇸Houston, Texas, United States
Southwest Regional Wound Care Center
🇺🇸Lubbock, Texas, United States
Richard G. Seegmiller, DPM
🇺🇸Bountiful, Utah, United States
Atlantic Foot & Ankle Center
🇺🇸Virginia Beach, Virginia, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Bone, Spine, Sports Center
🇺🇸Bismarck, North Dakota, United States
Associated Foot & Ankle Specialists, LLC
🇺🇸Phoenix, Arizona, United States
Bay Area Foot Care
🇺🇸San Francisco, California, United States
UNC Wound Care Clinic
🇺🇸Durham, North Carolina, United States
Barrett Quality Medical Interests, LP
🇺🇸San Antonio, Texas, United States
San Antonio Podiatry Associates, PC
🇺🇸San Antonio, Texas, United States
Douglas C. Flegal, DMP, FACFAS
🇺🇸Salt Lake City, Utah, United States
Diabetic Foot & Wound Center
🇺🇸Denver, Colorado, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
David Fivenson, MD, Dermatology, PLLC
🇺🇸Ann Arbor, Michigan, United States
Carl T. Hayden VA Medical Center
🇺🇸Phoenix, Arizona, United States
Aung Foot Health Clinics & Advanced Wound Care
🇺🇸Tucson, Arizona, United States