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

Last updated: May 24, 2012
Sponsor: Pfizer
Overall Status: Terminated

Phase

2

Condition

Ulcers

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT00318214
MRE0094P-202
  • Ages 18-85
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 a large ulcer or multiple ulcers on the bottom surface of their foot that hasbeen 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

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 an off-loading device during the study to take pressure off theulcer.

  • They have certain other diseases, or are using certain types of drugs.

Study Design

Total Participants: 16
Study Start date:
June 01, 2006
Estimated Completion Date:
February 29, 2008

Connect with a study center

  • Associated Foot & Ankle Specialists, LLC

    Phoenix, Arizona 85015
    United States

    Site Not Available

  • Southern Arizona VA Health Care System

    Tucson, Arizona 85723
    United States

    Site Not Available

  • Roy O. Kroeker, DPM

    Fresno, California 93710
    United States

    Site Not Available

  • Innovative Medical Technologies

    Los Angeles, California 90063
    United States

    Site Not Available

  • Diabetic Foot & Wound Center

    Denver, Colorado 80220
    United States

    Site Not Available

  • North American Center for Limb Preservation

    New Haven, Connecticut 06515
    United States

    Site Not Available

  • Karr Foot & Leg Centers

    Lakeland, Florida 33813
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Ankle and Foot Specialist of Atlanta

    Lithonia, Georgia 30058
    United States

    Site Not Available

  • Foot Healthcare Associates

    Livonia, Michigan 48152
    United States

    Site Not Available

  • Northern Michigan Hospital

    Petoskey, Michigan 49770
    United States

    Site Not Available

  • Calvary Hospital

    Bronx, New York 10461
    United States

    Site Not Available

  • North Shore Podiatry Group

    Port Jefferson Station, New York 11776
    United States

    Site Not Available

  • UNC Wound Care Clinic

    Durham, North Carolina 27713
    United States

    Site Not Available

  • Eastern Carolina Foot & Ankle Specialists

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Lehigh Valley Podiatry Associates

    Allentown, Pennsylvania 18104
    United States

    Site Not Available

  • Limb Salvage Center

    Dallas, Texas 75231
    United States

    Site Not Available

  • Southwest Regional Wound Care

    Lubbock, Texas 79410
    United States

    Site Not Available

  • St. Luke's Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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