Stopped: The study had poor enrollment with only 16 patients randomized across 19 study centers over an 18-month period.
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.
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Systemic exposure to topical MRE0094 measured by plasma concentrations of MRE0094.
Timeframe: Baseline (Day 1) to endpoint or 90 days, whichever is earlier
Incidence, intensity, and seriousness of adverse events (AEs).
Timeframe: Baseline (Day 1) to endpoint or 90 days, whichever is earlier
Changes in irritation scores.
Timeframe: From baseline to the various treatment visits
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)