Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers
1 other identifier
interventional
322
1 country
63
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2005
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 6, 2006
CompletedFirst Posted
Study publicly available on registry
April 10, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedJune 1, 2012
May 1, 2012
2 years
April 6, 2006
May 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of complete healing of target ulcer at endpoint or 90 days, whichever is earlier.
Secondary Outcomes (2)
Time to closure and percent reduction in surface area of the target ulcer.
Incidence, intensity, and seriousness of adverse events. Changes in irritation scores.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (63)
Institute for Advanced Wound Care
Montgomery, Alabama, 36111, United States
Palo Verde Foot and Ankle
Bullhead City, Arizona, 86442, United States
Carl T. Hayden VA Medical Center
Phoenix, Arizona, 85012, United States
Associated Foot & Ankle Specialists, LLC
Phoenix, Arizona, 85015, United States
Aung Foot Health Clinics & Advanced Wound Care
Tucson, Arizona, 85710, United States
Southern Arizona VA Health Care System
Tucson, Arizona, 85723, United States
Vertex Clinical Research
Bakersfield, California, 93311, United States
Roy O. Kroeker, DPM
Fresno, California, 93710, United States
Innovative Medical Technologies
Los Angeles, California, 90063, United States
UCSD Wound Treatment and Research Center
San Diego, California, 92103, United States
Bay Area Foot Care
San Francisco, California, 94115, United States
Walter F. D'Costa, DPM
Santa Rosa, California, 95403, United States
Diabetic Foot & Wound Center
Denver, Colorado, 80220, United States
North American Center for Limb Preservation
New Haven, Connecticut, 06515, United States
Christiana Care Health Systems Wound Care Center
Wilmington, Delaware, 19802, United States
Countryside Foot and Ankle Center
Clearwater, Florida, 33763, United States
Karr Foot & Leg Centers
Lakeland, Florida, 33813, United States
University of Miami
Miami, Florida, 33136, United States
Baptist Hospital
Pensacola, Florida, 32501, United States
Doctor's Research Network
South Miami, Florida, 33143, United States
Dr. Robert J. Snyder
Tamarac, Florida, 33321, United States
Ankle and Foot Specialist of Atlanta
Lithonia, Georgia, 30058, United States
Podiatry Center of Idaho, PLLC
Boise, Idaho, 83713, United States
Adam S. Landsman, DPM, PhD, FACFAS
Highland Park, Illinois, 60035, United States
Advocate Lutheran General Hospital
Niles, Illinois, 60714, United States
North Chicago VA Medical Center
North Chicago, Illinois, 60064, United States
Thomas Kevin Brattain, DPM
Peoria, Illinois, 61614, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Welborn Clinic
Evansville, Indiana, 47713, United States
The Wound Healing Center
Terre Haute, Indiana, 47807, United States
Dolby Research, LLC
Baton Rouge, Louisiana, 70809, United States
David Fivenson, MD, Dermatology, PLLC
Ann Arbor, Michigan, 48103, United States
Foot Healthcare Associates
Livonia, Michigan, 48152, United States
Northern Michigan Hospital
Petoskey, Michigan, 49770, United States
Foot & Ankle Physicians
Union, New Jersey, 07083, United States
St. John's Queens Hospital
Elmhurst, New York, 11373, United States
North Shore Podiatry Group
Port Jefferson Station, New York, 11776, United States
Calvary Hospital
The Bronx, New York, 10461, United States
Upstate Clinical Research Associates
Williamsville, New York, 14221, United States
UNC Wound Care Clinic
Durham, North Carolina, 27713, United States
Eastern Carolina Foot & Ankle Specialists
Greenville, North Carolina, 27834, United States
Bone, Spine, Sports Center
Bismarck, North Dakota, 58501, United States
Austintown Podiatry Associates, Inc.
Austintown, Ohio, 44515, United States
New Horizons Clinical Research
Cincinnati, Ohio, 45242, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Optimed Research, LLC
Columbus, Ohio, 43235, United States
Lehigh Valley Podiatry Associates
Allentown, Pennsylvania, 18104, United States
Advanced Regional Center for Ankle and Foot Care
Altoona, Pennsylvania, 16602, United States
UPMC Horizon
Farrell, Pennsylvania, 16121, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Foot and Ankle Institute
Philadelphia, Pennsylvania, 19107, United States
Prigoff-Bowers, LLP
Dallas, Texas, 75224, United States
Limb Salvage Center
Dallas, Texas, 75231, United States
South Texas Foot Institute
Floresville, Texas, 78114, United States
Memorial Hermann Wound Center
Houston, Texas, 77030, United States
Southwest Regional Wound Care Center
Lubbock, Texas, 79410, United States
Barrett Quality Medical Interests, LP
San Antonio, Texas, 78216, United States
San Antonio Podiatry Associates, PC
San Antonio, Texas, 78229, United States
Richard G. Seegmiller, DPM
Bountiful, Utah, 84010, United States
Douglas C. Flegal, DMP, FACFAS
Salt Lake City, Utah, 48103, United States
Atlantic Foot & Ankle Center
Virginia Beach, Virginia, 23454, United States
Madigan Army Medical Center
Tacoma, Washington, 98431-1100, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 6, 2006
First Posted
April 10, 2006
Study Start
December 1, 2005
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
June 1, 2012
Record last verified: 2012-05