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

Completed · Phase 2

Conditions studied: Foot Ulcer, Diabetic, Diabetes Complications

In brief

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.

Key facts

Study ID

NCT00312364

Run by

Pfizer

People needed

322

Starts

2005-12-01

Expected to finish

2007-12-01

Last updated by the study team

2012-06-01

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Palo Verde Foot and Ankle — Bullhead City, Arizona, United States
• Carl T. Hayden VA Medical Center — Phoenix, Arizona, United States
• Associated Foot & Ankle Specialists, LLC — Phoenix, Arizona, United States
• Aung Foot Health Clinics & Advanced Wound Care — Tucson, 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
• UCSD Wound Treatment and Research Center — San Diego, California, United States
• Bay Area Foot Care — San Francisco, California, United States
• Walter F. D'Costa, DPM — Santa Rosa, California, United States
• Diabetic Foot & Wound Center — Denver, Colorado, 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
• Institute for Advanced Wound Care — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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