Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers

• Status: Terminated
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and preliminary efficacy of low dose nicotine gel in patients with chronic diabetic ulcers

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CoMentis
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• Patients with diabetes mellitus type II

• Single non-healing uninfected partial or full-thickness foot ulcer secondary to diabetic neuropathy, in the absence of significant peripheral arterial disease.

Exclusion Criteria:

• Patients who use tobacco in any form or who are on nicotine replacement therapy