Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers

Stopped early · 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. The purpose of the study is to determine the safety of the experimental drug when applied to large, diabetic foot ulcers. The study will also determine if the experimental drug can safely promote healing of diabetic foot ulcers better than standard treatments currently available to doctors. 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.

Key facts

Study ID

NCT00318214

Run by

Pfizer

People needed

16

Starts

2006-06-01

Expected to finish

2008-02-01

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 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.

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 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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