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

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.

Timeline

Start

2006-06

Primary completion

2008-02

Completion

2008-02

Outcome

Outcome not reported

Stopped (Enrollment): “The study had poor enrollment with only 16 patients randomized across 19 study centers over an 18-month period.”

Drugs

Indications