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

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.

• Foot Ulcer, Diabetic
• Diabetes Complications

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

• Experimental: 1
  Intervention: Drug: MRE0094
• Placebo Comparator: 2
  Intervention: Drug: Vehicle gel

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.