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

Diabetes Complications Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312364
• Other study ID #: MRE0094P-201
• Status: Completed
• Phase: Phase 2
• First received: April 6, 2006
• Last updated: May 24, 2012
• Start date: December 2005
• Est. completion date: December 2007

Study information

• Verified date: May 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer

Intervention

Drug:
• MRE0094

Locations

Country	Name	City	State
United States	Lehigh Valley Podiatry Associates	Allentown	Pennsylvania
United States	Advanced Regional Center for Ankle and Foot Care	Altoona	Pennsylvania
United States	David Fivenson, MD, Dermatology, PLLC	Ann Arbor	Michigan
United States	Austintown Podiatry Associates, Inc.	Austintown	Ohio
United States	Vertex Clinical Research	Bakersfield	California
United States	Dolby Research, LLC	Baton Rouge	Louisiana
United States	Bone, Spine, Sports Center	Bismarck	North Dakota
United States	Podiatry Center of Idaho, PLLC	Boise	Idaho
United States	Richard G. Seegmiller, DPM	Bountiful	Utah
United States	Calvary Hospital	Bronx	New York
United States	Palo Verde Foot and Ankle	Bullhead City	Arizona
United States	New Horizons Clinical Research	Cincinnati	Ohio
United States	Countryside Foot and Ankle Center	Clearwater	Florida
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Optimed Research, LLC	Columbus	Ohio
United States	Limb Salvage Center	Dallas	Texas
United States	Prigoff-Bowers, LLP	Dallas	Texas
United States	Diabetic Foot & Wound Center	Denver	Colorado
United States	UNC Wound Care Clinic	Durham	North Carolina
United States	St. John's Queens Hospital	Elmhurst	New York
United States	Welborn Clinic	Evansville	Indiana
United States	UPMC Horizon	Farrell	Pennsylvania
United States	South Texas Foot Institute	Floresville	Texas
United States	Roy O. Kroeker, DPM	Fresno	California
United States	Eastern Carolina Foot & Ankle Specialists	Greenville	North Carolina
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Adam S. Landsman, DPM, PhD, FACFAS	Highland Park	Illinois
United States	Memorial Hermann Wound Center	Houston	Texas
United States	Karr Foot & Leg Centers	Lakeland	Florida
United States	Ankle and Foot Specialist of Atlanta	Lithonia	Georgia
United States	Foot Healthcare Associates	Livonia	Michigan
United States	Innovative Medical Technologies	Los Angeles	California
United States	Southwest Regional Wound Care Center	Lubbock	Texas
United States	University of Miami	Miami	Florida
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Institute for Advanced Wound Care	Montgomery	Alabama
United States	North American Center for Limb Preservation	New Haven	Connecticut
United States	Advocate Lutheran General Hospital	Niles	Illinois
United States	North Chicago VA Medical Center	North Chicago	Illinois
United States	Baptist Hospital	Pensacola	Florida
United States	Thomas Kevin Brattain, DPM	Peoria	Illinois
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	Foot and Ankle Institute	Philadelphia	Pennsylvania
United States	Associated Foot & Ankle Specialists, LLC	Phoenix	Arizona
United States	Carl T. Hayden VA Medical Center	Phoenix	Arizona
United States	North Shore Podiatry Group	Port Jefferson Station	New York
United States	Douglas C. Flegal, DMP, FACFAS	Salt Lake City	Utah
United States	Barrett Quality Medical Interests, LP	San Antonio	Texas
United States	San Antonio Podiatry Associates, PC	San Antonio	Texas
United States	UCSD Wound Treatment and Research Center	San Diego	California
United States	Bay Area Foot Care	San Francisco	California
United States	Walter F. D'Costa, DPM	Santa Rosa	California
United States	Doctor's Research Network	South Miami	Florida
United States	Madigan Army Medical Center	Tacoma	Washington
United States	Dr. Robert J. Snyder	Tamarac	Florida
United States	The Wound Healing Center	Terre Haute	Indiana
United States	Aung Foot Health Clinics & Advanced Wound Care	Tucson	Arizona
United States	Southern Arizona VA Health Care System	Tucson	Arizona
United States	Foot & Ankle Physicians	Union	New Jersey
United States	Carle Foundation Hospital	Urbana	Illinois
United States	Atlantic Foot & Ankle Center	Virginia Beach	Virginia
United States	Upstate Clinical Research Associates	Williamsville	New York
United States	Christiana Care Health Systems Wound Care Center	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of complete healing of target ulcer at endpoint or 90 days, whichever is earlier.
Secondary	Time to closure and percent reduction in surface area of the target ulcer.
Secondary	Incidence, intensity, and seriousness of adverse events. Changes in irritation scores.