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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
322
Institute for Advanced Wound Care
Montgomery, Alabama, United States
Palo Verde Foot and Ankle
Bullhead City, Arizona, United States
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States
Associated Foot & Ankle Specialists, LLC
Phoenix, Arizona, United States
Aung Foot Health Clinics & Advanced Wound Care
Tucson, Arizona, United States
Incidence of complete healing of target ulcer at endpoint or 90 days, whichever is earlier.
Time to closure and percent reduction in surface area of the target ulcer.
Incidence, intensity, and seriousness of adverse events. Changes in irritation scores.
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Southern Arizona VA Health Care System
Tucson, Arizona, United States
Vertex Clinical Research
Bakersfield, California, United States
Roy O. Kroeker, DPM
Fresno, California, United States
Innovative Medical Technologies
Los Angeles, California, United States
UCSD Wound Treatment and Research Center
San Diego, California, United States
...and 53 more locations