Clinical trial NCT00318214: Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
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: 2006-04-26
Enrollment: 16
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. 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.


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 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.

Primary outcomes:
measure: Systemic exposure to topical MRE0094 measured by plasma concentrations of MRE0094.
timeFrame: Baseline (Day 1) to endpoint or 90 days, whichever is earlier
measure: Incidence, intensity, and seriousness of adverse events (AEs).
timeFrame: Baseline (Day 1) to endpoint or 90 days, whichever is earlier
measure: Changes in irritation scores.
timeFrame: From baseline to the various treatment visits
measure: Changes in electrocardiograms (ECGs), vital signs, and clinical laboratory values.
timeFrame: Baseline, Day 50, and Day 90 (EGCs); from baseline to the various treatment visits (vital signs and lab values)
Secondary outcomes:
measure: Incidence of complete healing of target ulcer
timeFrame: At endpoint or 90 days, whichever is earlier
measure: Time to closure and percent reduction in surface area of the target ulcer.
timeFrame: From baseline (Day 1) to the various treatment visits
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Associated Foot & Ankle Specialists, LLC
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
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: 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: Lakeland
country: United States
facility: Karr Foot & Leg Centers
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Lithonia
country: United States
facility: Ankle and Foot Specialist of Atlanta
state: Georgia
city: Livonia
country: United States
facility: Foot Healthcare Associates
state: Michigan
city: Petoskey
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: Bronx
country: United States
facility: Calvary Hospital
state: New York
city: Port Jefferson Station
country: United States
facility: North Shore Podiatry Group
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: Allentown
country: United States
facility: Lehigh Valley Podiatry Associates
state: Pennsylvania
city: Dallas
country: United States
facility: Limb Salvage Center
state: Texas
city: Lubbock
country: United States
facility: Southwest Regional Wound Care
state: Texas
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
name: Robert L. Rolleri, Pharm.D.
role: STUDY_DIRECTOR
References: