Clinical trial NCT00312364: Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Foot Ulcer, Diabetic
Diabetes Complications
Keywords: toe ulcer
heel ulcer
foot ulcer
diabetic feet
diabetic foot
complications of diabetes
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-04-10
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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 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.

Primary outcomes:
measure: Incidence of complete healing of target ulcer at endpoint or 90 days, whichever is earlier.
Secondary outcomes:
measure: Time to closure and percent reduction in surface area of the target ulcer.
measure: Incidence, intensity, and seriousness of adverse events. Changes in irritation scores.
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Institute for Advanced Wound Care
state: Alabama
city: Bullhead City
country: United States
facility: Palo Verde Foot and Ankle
state: Arizona
city: Phoenix
country: United States
facility: Carl T. Hayden VA Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Associated Foot & Ankle Specialists, LLC
state: Arizona
city: Tucson
country: United States
facility: Aung Foot Health Clinics & Advanced Wound Care
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Bakersfield
country: United States
facility: Vertex Clinical Research
state: California
city: Fresno
country: United States
facility: Roy O. Kroeker, DPM
state: California
city: Los Angeles
country: United States
facility: Innovative Medical Technologies
state: California
city: San Diego
country: United States
facility: UCSD Wound Treatment and Research Center
state: California
city: San Francisco
country: United States
facility: Bay Area Foot Care
state: California
city: Santa Rosa
country: United States
facility: Walter F. D'Costa, DPM
state: California
city: Denver
country: United States
facility: Diabetic Foot & Wound Center
state: Colorado
city: New Haven
country: United States
facility: North American Center for Limb Preservation
state: Connecticut
city: Wilmington
country: United States
facility: Christiana Care Health Systems Wound Care Center
state: Delaware
city: Clearwater
country: United States
facility: Countryside Foot and Ankle Center
state: Florida
city: Lakeland
country: United States
facility: Karr Foot & Leg Centers
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Pensacola
country: United States
facility: Baptist Hospital
state: Florida
city: South Miami
country: United States
facility: Doctor's Research Network
state: Florida
city: Tamarac
country: United States
facility: Dr. Robert J. Snyder
state: Florida
city: Lithonia
country: United States
facility: Ankle and Foot Specialist of Atlanta
state: Georgia
city: Boise
country: United States
facility: Podiatry Center of Idaho, PLLC
state: Idaho
city: Highland Park
country: United States
facility: Adam S. Landsman, DPM, PhD, FACFAS
state: Illinois
city: Niles
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: North Chicago
country: United States
facility: North Chicago VA Medical Center
state: Illinois
city: Peoria
country: United States
facility: Thomas Kevin Brattain, DPM
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Evansville
country: United States
facility: Welborn Clinic
state: Indiana
city: Terre Haute
country: United States
facility: The Wound Healing Center
state: Indiana
city: Baton Rouge
country: United States
facility: Dolby Research, LLC
state: Louisiana
city: Ann Arbor
country: United States
facility: David Fivenson, MD, Dermatology, PLLC
state: Michigan
city: Livonia
country: United States
facility: Foot Healthcare Associates
state: Michigan
city: Petoskey
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: Union
country: United States
facility: Foot & Ankle Physicians
state: New Jersey
city: Bronx
country: United States
facility: Calvary Hospital
state: New York
city: Elmhurst
country: United States
facility: St. John's Queens Hospital
state: New York
city: Port Jefferson Station
country: United States
facility: North Shore Podiatry Group
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates
state: New York
city: Durham
country: United States
facility: UNC Wound Care Clinic
state: North Carolina
city: Greenville
country: United States
facility: Eastern Carolina Foot & Ankle Specialists
state: North Carolina
city: Bismarck
country: United States
facility: Bone, Spine, Sports Center
state: North Dakota
city: Austintown
country: United States
facility: Austintown Podiatry Associates, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Optimed Research, LLC
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Podiatry Associates
state: Pennsylvania
city: Altoona
country: United States
facility: Advanced Regional Center for Ankle and Foot Care
state: Pennsylvania
city: Farrell
country: United States
facility: UPMC Horizon
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Foot and Ankle Institute
state: Pennsylvania
city: Dallas
country: United States
facility: Prigoff-Bowers, LLP
state: Texas
city: Dallas
country: United States
facility: Limb Salvage Center
state: Texas
city: Floresville
country: United States
facility: South Texas Foot Institute
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Wound Center
state: Texas
city: Lubbock
country: United States
facility: Southwest Regional Wound Care Center
state: Texas
city: San Antonio
country: United States
facility: Barrett Quality Medical Interests, LP
state: Texas
city: San Antonio
country: United States
facility: San Antonio Podiatry Associates, PC
state: Texas
city: Bountiful
country: United States
facility: Richard G. Seegmiller, DPM
state: Utah
city: Salt Lake City
country: United States
facility: Douglas C. Flegal, DMP, FACFAS
state: Utah
city: Virginia Beach
country: United States
facility: Atlantic Foot & Ankle Center
state: Virginia
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
Study officials:
References: