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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
Gel, 500 mcg/g once each day
Gel administered once per day
Associated Foot & Ankle Specialists, LLC
Phoenix, Arizona, United States
Southern Arizona VA Health Care System
Tucson, Arizona, United States
Roy O. Kroeker, DPM
Fresno, California, United States
Innovative Medical Technologies
Los Angeles, California, United States
Diabetic Foot & Wound Center
Denver, Colorado, United States
North American Center for Limb Preservation
New Haven, Connecticut, United States
Karr Foot & Leg Centers
Lakeland, Florida, United States
University of Miami
Miami, Florida, United States
Ankle and Foot Specialist of Atlanta
Lithonia, Georgia, United States
Foot Healthcare Associates
Livonia, Michigan, United States
...and 9 more locations
Systemic exposure to topical MRE0094 measured by plasma concentrations of MRE0094.
Time frame: Baseline (Day 1) to endpoint or 90 days, whichever is earlier
Incidence, intensity, and seriousness of adverse events (AEs).
Time frame: Baseline (Day 1) to endpoint or 90 days, whichever is earlier
Changes in irritation scores.
Time frame: From baseline to the various treatment visits
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)
Incidence of complete healing of target ulcer
Time frame: At endpoint or 90 days, whichever is earlier
Time to closure and percent reduction in surface area of the target ulcer.
Time frame: From baseline (Day 1) to the various treatment visits
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