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

May 24, 2012 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

322

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36111
        • Institute for Advanced Wound Care
    • Arizona
      • Bullhead City, Arizona, United States, 86442
        • Palo Verde Foot and Ankle
      • Phoenix, Arizona, United States, 85012
        • Carl T. Hayden VA Medical Center
      • Phoenix, Arizona, United States, 85015
        • Associated Foot & Ankle Specialists, LLC
      • Tucson, Arizona, United States, 85723
        • Southern Arizona VA Health Care System
      • Tucson, Arizona, United States, 85710
        • Aung Foot Health Clinics & Advanced Wound Care
    • California
      • Bakersfield, California, United States, 93311
        • Vertex Clinical Research
      • Fresno, California, United States, 93710
        • Roy O. Kroeker, DPM
      • Los Angeles, California, United States, 90063
        • Innovative Medical Technologies
      • San Diego, California, United States, 92103
        • UCSD Wound Treatment and Research Center
      • San Francisco, California, United States, 94115
        • Bay Area Foot Care
      • Santa Rosa, California, United States, 95403
        • Walter F. D'Costa, DPM
    • Colorado
      • Denver, Colorado, United States, 80220
        • Diabetic Foot & Wound Center
    • Connecticut
      • New Haven, Connecticut, United States, 06515
        • North American Center for Limb Preservation
    • Delaware
      • Wilmington, Delaware, United States, 19802
        • Christiana Care Health Systems Wound Care Center
    • Florida
      • Clearwater, Florida, United States, 33763
        • Countryside Foot and Ankle Center
      • Lakeland, Florida, United States, 33813
        • Karr Foot & Leg Centers
      • Miami, Florida, United States, 33136
        • University of Miami
      • Pensacola, Florida, United States, 32501
        • Baptist Hospital
      • South Miami, Florida, United States, 33143
        • Doctor's Research Network
      • Tamarac, Florida, United States, 33321
        • Dr. Robert J. Snyder
    • Georgia
      • Lithonia, Georgia, United States, 30058
        • Ankle and Foot Specialist of Atlanta
    • Idaho
      • Boise, Idaho, United States, 83713
        • Podiatry Center of Idaho, PLLC
    • Illinois
      • Highland Park, Illinois, United States, 60035
        • Adam S. Landsman, DPM, PhD, FACFAS
      • Niles, Illinois, United States, 60714
        • Advocate Lutheran General Hospital
      • North Chicago, Illinois, United States, 60064
        • North Chicago VA Medical Center
      • Peoria, Illinois, United States, 61614
        • Thomas Kevin Brattain, DPM
      • Urbana, Illinois, United States, 61801
        • Carle Foundation Hospital
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Welborn Clinic
      • Terre Haute, Indiana, United States, 47807
        • The Wound Healing Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Dolby Research, LLC
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • David Fivenson, MD, Dermatology, PLLC
      • Livonia, Michigan, United States, 48152
        • Foot Healthcare Associates
      • Petoskey, Michigan, United States, 49770
        • Northern Michigan Hospital
    • New Jersey
      • Union, New Jersey, United States, 07083
        • Foot & Ankle Physicians
    • New York
      • Bronx, New York, United States, 10461
        • Calvary Hospital
      • Elmhurst, New York, United States, 11373
        • St. John's Queens Hospital
      • Port Jefferson Station, New York, United States, 11776
        • North Shore Podiatry Group
      • Williamsville, New York, United States, 14221
        • Upstate Clinical Research Associates
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • UNC Wound Care Clinic
      • Greenville, North Carolina, United States, 27834
        • Eastern Carolina Foot & Ankle Specialists
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Bone, Spine, Sports Center
    • Ohio
      • Austintown, Ohio, United States, 44515
        • Austintown Podiatry Associates, Inc.
      • Cincinnati, Ohio, United States, 45242
        • New Horizons Clinical Research
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43235
        • Optimed Research, LLC
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Lehigh Valley Podiatry Associates
      • Altoona, Pennsylvania, United States, 16602
        • Advanced Regional Center for Ankle and Foot Care
      • Farrell, Pennsylvania, United States, 16121
        • UPMC Horizon
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Foot and Ankle Institute
    • Texas
      • Dallas, Texas, United States, 75231
        • Limb Salvage Center
      • Dallas, Texas, United States, 75224
        • Prigoff-Bowers, LLP
      • Floresville, Texas, United States, 78114
        • South Texas Foot Institute
      • Houston, Texas, United States, 77030
        • Memorial Hermann Wound Center
      • Lubbock, Texas, United States, 79410
        • Southwest Regional Wound Care Center
      • San Antonio, Texas, United States, 78216
        • Barrett Quality Medical Interests, LP
      • San Antonio, Texas, United States, 78229
        • San Antonio Podiatry Associates, PC
    • Utah
      • Bountiful, Utah, United States, 84010
        • Richard G. Seegmiller, DPM
      • Salt Lake City, Utah, United States, 48103
        • Douglas C. Flegal, DMP, FACFAS
    • Virginia
      • Virginia Beach, Virginia, United States, 23454
        • Atlantic Foot & Ankle Center
    • Washington
      • Tacoma, Washington, United States, 98431-1100
        • Madigan Army Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of complete healing of target ulcer at endpoint or 90 days, whichever is earlier.

Secondary Outcome Measures

Outcome Measure
Time to closure and percent reduction in surface area of the target ulcer.
Incidence, intensity, and seriousness of adverse events. Changes in irritation scores.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

April 6, 2006

First Submitted That Met QC Criteria

April 6, 2006

First Posted (Estimate)

April 10, 2006

Study Record Updates

Last Update Posted (Estimate)

June 1, 2012

Last Update Submitted That Met QC Criteria

May 24, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRE0094P-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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