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

This study has been terminated.
(The study had poor enrollment with only 16 patients randomized across 19 study centers over an 18-month period.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00318214
First received: April 24, 2006
Last updated: May 24, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Foot Ulcer, Diabetic
Diabetes Complications
Drug: MRE0094
Drug: Vehicle gel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Systemic exposure to topical MRE0094 measured by plasma concentrations of MRE0094. [ Time Frame: Baseline (Day 1) to endpoint or 90 days, whichever is earlier ] [ Designated as safety issue: Yes ]
  • Incidence, intensity, and seriousness of adverse events (AEs). [ Time Frame: Baseline (Day 1) to endpoint or 90 days, whichever is earlier ] [ Designated as safety issue: Yes ]
  • Changes in irritation scores. [ Time Frame: From baseline to the various treatment visits ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of complete healing of target ulcer [ Time Frame: At endpoint or 90 days, whichever is earlier ] [ Designated as safety issue: No ]
  • Time to closure and percent reduction in surface area of the target ulcer. [ Time Frame: From baseline (Day 1) to the various treatment visits ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: June 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MRE0094
Gel, 500 mcg/g once each day
Placebo Comparator: 2 Drug: Vehicle gel
Gel administered once per day

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318214

Locations
United States, Arizona
Associated Foot & Ankle Specialists, LLC
Phoenix, Arizona, United States, 85015
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
United States, California
Roy O. Kroeker, DPM
Fresno, California, United States, 93710
Innovative Medical Technologies
Los Angeles, California, United States, 90063
United States, Colorado
Diabetic Foot & Wound Center
Denver, Colorado, United States, 80220
United States, Connecticut
North American Center for Limb Preservation
New Haven, Connecticut, United States, 06515
United States, Florida
Karr Foot & Leg Centers
Lakeland, Florida, United States, 33813
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Ankle and Foot Specialist of Atlanta
Lithonia, Georgia, United States, 30058
United States, Michigan
Foot Healthcare Associates
Livonia, Michigan, United States, 48152
Northern Michigan Hospital
Petoskey, Michigan, United States, 49770
United States, New York
Calvary Hospital
Bronx, New York, United States, 10461
North Shore Podiatry Group
Port Jefferson Station, New York, United States, 11776
United States, North Carolina
UNC Wound Care Clinic
Durham, North Carolina, United States, 27713
Eastern Carolina Foot & Ankle Specialists
Greenville, North Carolina, United States, 27834
United States, Pennsylvania
Lehigh Valley Podiatry Associates
Allentown, Pennsylvania, United States, 18104
United States, Texas
Limb Salvage Center
Dallas, Texas, United States, 75231
Southwest Regional Wound Care
Lubbock, Texas, United States, 79410
United States, Wisconsin
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Robert L. Rolleri, Pharm.D. King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00318214     History of Changes
Other Study ID Numbers: MRE0094P-202
Study First Received: April 24, 2006
Last Updated: May 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
toe ulcer
heel ulcer
foot ulcer
diabetic feet
diabetic foot
complications of diabetes

Additional relevant MeSH terms:
Diabetic Foot
Ulcer
Foot Ulcer
Diabetes Complications
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Pathologic Processes
Foot Diseases

ClinicalTrials.gov processed this record on September 22, 2014