Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, 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. 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

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
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Associated Foot & Ankle Specialists, LLC
      • Tucson, Arizona, United States, 85723
        • Southern Arizona VA Health Care System
    • California
      • Fresno, California, United States, 93710
        • Roy O. Kroeker, DPM
      • Los Angeles, California, United States, 90063
        • Innovative Medical Technologies
    • Colorado
      • Denver, Colorado, United States, 80220
        • Diabetic Foot & Wound Center
    • Connecticut
      • New Haven, Connecticut, United States, 06515
        • North American Center for Limb Preservation
    • Florida
      • Lakeland, Florida, United States, 33813
        • Karr Foot & Leg Centers
      • Miami, Florida, United States, 33136
        • University of Miami
    • Georgia
      • Lithonia, Georgia, United States, 30058
        • Ankle and Foot Specialist of Atlanta
    • Michigan
      • Livonia, Michigan, United States, 48152
        • Foot Healthcare Associates
      • Petoskey, Michigan, United States, 49770
        • Northern Michigan Hospital
    • New York
      • Bronx, New York, United States, 10461
        • Calvary Hospital
      • Port Jefferson Station, New York, United States, 11776
        • North Shore Podiatry Group
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • UNC Wound Care Clinic
      • Greenville, North Carolina, United States, 27834
        • Eastern Carolina Foot & Ankle Specialists
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Lehigh Valley Podiatry Associates
    • Texas
      • Dallas, Texas, United States, 75231
        • Limb Salvage Center
      • Lubbock, Texas, United States, 79410
        • Southwest Regional Wound Care
    • 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 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.

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 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: MRE0094
Gel, 500 mcg/g once each day
Placebo Comparator: 2
Drug: Vehicle gel
Gel administered once per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Systemic exposure to topical MRE0094 measured by plasma concentrations of MRE0094.
Time Frame: Baseline (Day 1) to endpoint or 90 days, whichever is earlier
Baseline (Day 1) to endpoint or 90 days, whichever is earlier
Incidence, intensity, and seriousness of adverse events (AEs).
Time Frame: Baseline (Day 1) to endpoint or 90 days, whichever is earlier
Baseline (Day 1) to endpoint or 90 days, whichever is earlier
Changes in irritation scores.
Time Frame: From baseline to the various treatment visits
From baseline to the various treatment visits
Changes in electrocardiograms (ECGs), vital signs, and clinical laboratory values.
Time Frame: Baseline, Day 50, and Day 90 (EGCs); from baseline to the various treatment visits (vital signs and lab values)
Baseline, Day 50, and Day 90 (EGCs); from baseline to the various treatment visits (vital signs and lab values)

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of complete healing of target ulcer
Time Frame: At endpoint or 90 days, whichever is earlier
At endpoint or 90 days, whichever is earlier
Time to closure and percent reduction in surface area of the target ulcer.
Time Frame: From baseline (Day 1) to the various treatment visits
From baseline (Day 1) to the various treatment visits

Collaborators and Investigators

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

Sponsor

Pfizer

Investigators

  • Study Director: Robert L. Rolleri, Pharm.D., King Pharmaceuticals is now a wholly owned subsidiary of 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

June 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

April 24, 2006

First Submitted That Met QC Criteria

April 25, 2006

First Posted (Estimate)

April 26, 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-202

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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