Trial Information

Summary: Do you have a diabetic foot ulcer?

Madison Skin & Research, Inc., is currently seeking volunteers to participate in a research in a research study to evaluate the safety and efficacy of 3 different doses of a topical applied investigational medication (tolbermin) versus placebo (dummy gel) in subjects 18 to 80 years old with diabetic foot ulcers. If you qualify to participate in this study, participation will last about 26 weeks. This includes a 1-week screening period, a 1 week run-in period, a 12 week treatment period, and a 12 week follow-up period (during which you will not use any study gel). You will have to come to the study center about 21 times during the study. Visit are weekly during the study gel period and every 2 weeks during the follow-up period. Blood will be drawn about 21 times during the study, along with photographs and measurements of the ulcer will be done during the study.

Inclusion Criteria

• Age 18 to 80 years old
• Have Type 1 or 2 diabetes mellitus
• At least 1 foot ulcer
• Hemoglobin A1C (HbA1c) = 12%

Exclusion Criteria

• Presence of an active cancer or tumor of any kind
• Proliferate diabetic retinopathy or wet age-related macular degeneration
• A history of heart failure or pulmonary edema
• Has connective tissue disease
• Pregnant or lactating
• Treatment with systemic corticosteroids, or immunosuppressive or chemotherapeutic agents within 14 days to first study gel application
• A psychiatric condition or chronic alcohol or drug abuse problem

If you would like to learn more about participating in this study, please send an e-mail message using the form below.