Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers

NCT ID: NCT00312364

Last Updated: 2012-06-01

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-12-31

Brief Summary

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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

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Conditions

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Foot Ulcer, Diabetic Diabetes Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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MRE0094

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Locations

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Institute for Advanced Wound Care

Montgomery, Alabama, United States

Site Status

Palo Verde Foot and Ankle

Bullhead City, Arizona, United States

Site Status

Carl T. Hayden VA Medical Center

Phoenix, Arizona, United States

Site Status

Associated Foot & Ankle Specialists, LLC

Phoenix, Arizona, United States

Site Status

Aung Foot Health Clinics & Advanced Wound Care

Tucson, Arizona, United States

Site Status

Southern Arizona VA Health Care System

Tucson, Arizona, United States

Site Status

Vertex Clinical Research

Bakersfield, California, United States

Site Status

Roy O. Kroeker, DPM

Fresno, California, United States

Site Status

Innovative Medical Technologies

Los Angeles, California, United States

Site Status

UCSD Wound Treatment and Research Center

San Diego, California, United States

Site Status

Bay Area Foot Care

San Francisco, California, United States

Site Status

Walter F. D'Costa, DPM

Santa Rosa, California, United States

Site Status

Diabetic Foot & Wound Center

Denver, Colorado, United States

Site Status

North American Center for Limb Preservation

New Haven, Connecticut, United States

Site Status

Christiana Care Health Systems Wound Care Center

Wilmington, Delaware, United States

Site Status

Countryside Foot and Ankle Center

Clearwater, Florida, United States

Site Status

Karr Foot & Leg Centers

Lakeland, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Baptist Hospital

Pensacola, Florida, United States

Site Status

Doctor's Research Network

South Miami, Florida, United States

Site Status

Dr. Robert J. Snyder

Tamarac, Florida, United States

Site Status

Ankle and Foot Specialist of Atlanta

Lithonia, Georgia, United States

Site Status

Podiatry Center of Idaho, PLLC

Boise, Idaho, United States

Site Status

Adam S. Landsman, DPM, PhD, FACFAS

Highland Park, Illinois, United States

Site Status

Advocate Lutheran General Hospital

Niles, Illinois, United States

Site Status

North Chicago VA Medical Center

North Chicago, Illinois, United States

Site Status

Thomas Kevin Brattain, DPM

Peoria, Illinois, United States

Site Status

Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

Welborn Clinic

Evansville, Indiana, United States

Site Status

The Wound Healing Center

Terre Haute, Indiana, United States

Site Status

Dolby Research, LLC

Baton Rouge, Louisiana, United States

Site Status

David Fivenson, MD, Dermatology, PLLC

Ann Arbor, Michigan, United States

Site Status

Foot Healthcare Associates

Livonia, Michigan, United States

Site Status

Northern Michigan Hospital

Petoskey, Michigan, United States

Site Status

Foot & Ankle Physicians

Union, New Jersey, United States

Site Status

St. John's Queens Hospital

Elmhurst, New York, United States

Site Status

North Shore Podiatry Group

Port Jefferson Station, New York, United States

Site Status

Calvary Hospital

The Bronx, New York, United States

Site Status

Upstate Clinical Research Associates

Williamsville, New York, United States

Site Status

UNC Wound Care Clinic

Durham, North Carolina, United States

Site Status

Eastern Carolina Foot & Ankle Specialists

Greenville, North Carolina, United States

Site Status

Bone, Spine, Sports Center

Bismarck, North Dakota, United States

Site Status

Austintown Podiatry Associates, Inc.

Austintown, Ohio, United States

Site Status

New Horizons Clinical Research

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Optimed Research, LLC

Columbus, Ohio, United States

Site Status

Lehigh Valley Podiatry Associates

Allentown, Pennsylvania, United States

Site Status

Advanced Regional Center for Ankle and Foot Care

Altoona, Pennsylvania, United States

Site Status

UPMC Horizon

Farrell, Pennsylvania, United States

Site Status

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Foot and Ankle Institute

Philadelphia, Pennsylvania, United States

Site Status

Prigoff-Bowers, LLP

Dallas, Texas, United States

Site Status

Limb Salvage Center

Dallas, Texas, United States

Site Status

South Texas Foot Institute

Floresville, Texas, United States

Site Status

Memorial Hermann Wound Center

Houston, Texas, United States

Site Status

Southwest Regional Wound Care Center

Lubbock, Texas, United States

Site Status

Barrett Quality Medical Interests, LP

San Antonio, Texas, United States

Site Status

San Antonio Podiatry Associates, PC

San Antonio, Texas, United States

Site Status

Richard G. Seegmiller, DPM

Bountiful, Utah, United States

Site Status

Douglas C. Flegal, DMP, FACFAS

Salt Lake City, Utah, United States

Site Status

Atlantic Foot & Ankle Center

Virginia Beach, Virginia, United States

Site Status

Madigan Army Medical Center

Tacoma, Washington, United States

Site Status

St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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MRE0094P-201

Identifier Type: -

Identifier Source: org_study_id

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