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

Diabetes Complications Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00318214
• Other study ID #: MRE0094P-202
• Status: Terminated
• Phase: Phase 2
• First received: April 24, 2006
• Last updated: May 24, 2012
• Start date: June 2006
• Est. completion date: February 2008

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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• 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 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 Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• MRE0094
Gel, 500 mcg/g once each day
• Vehicle gel
Gel administered once per day

Locations

Country	Name	City	State
United States	Lehigh Valley Podiatry Associates	Allentown	Pennsylvania
United States	Calvary Hospital	Bronx	New York
United States	Limb Salvage Center	Dallas	Texas
United States	Diabetic Foot & Wound Center	Denver	Colorado
United States	UNC Wound Care Clinic	Durham	North Carolina
United States	Roy O. Kroeker, DPM	Fresno	California
United States	Eastern Carolina Foot & Ankle Specialists	Greenville	North Carolina
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	Lubbock	Texas
United States	University of Miami	Miami	Florida
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	North American Center for Limb Preservation	New Haven	Connecticut
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	Associated Foot & Ankle Specialists, LLC	Phoenix	Arizona
United States	North Shore Podiatry Group	Port Jefferson Station	New York
United States	Southern Arizona VA Health Care System	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic exposure to topical MRE0094 measured by plasma concentrations of MRE0094.		Baseline (Day 1) to endpoint or 90 days, whichever is earlier	Yes
Primary	Incidence, intensity, and seriousness of adverse events (AEs).		Baseline (Day 1) to endpoint or 90 days, whichever is earlier	Yes
Primary	Changes in irritation scores.		From baseline to the various treatment visits	Yes
Primary	Changes in electrocardiograms (ECGs), vital signs, and clinical laboratory values.		Baseline, Day 50, and Day 90 (EGCs); from baseline to the various treatment visits (vital signs and lab values)	Yes
Secondary	Incidence of complete healing of target ulcer		At endpoint or 90 days, whichever is earlier	No
Secondary	Time to closure and percent reduction in surface area of the target ulcer.		From baseline (Day 1) to the various treatment visits	No