A Multicenter, Randomized Study of the Safety and Preliminary Efficacy of Low-Dose Nicotine Gel (ATG002) in Patients With Plantar Diabetic Foot Ulcers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Diabetic Foot Ulcers
- Sponsor
- CoMentis
- Enrollment
- 48
- Locations
- 13
- Primary Endpoint
- Assessment of ulcer size as determined by weekly ulcer tracings
- Status
- Terminated
- Last Updated
- 18 years ago
Overview
Brief 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
Detailed Description
This pilot study will be the first time that nicotine will be applied directly onto the surface of chronic diabetic ulcer. The goals of the study are to evaluate safety and tolerability (particularly at the wound site) of a gel formulation containing low-dose nicotine, and to obtain preliminary information on its effects on accelerating wound closure. The study will be carried out on a background of conventional wound therapy in patients with Type II diabetes mellitus. Patients will be randomized to receive either study medication (ATG002), vehicle gel, or standard-of-care.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Assessment of ulcer size as determined by weekly ulcer tracings
Secondary Outcomes
- Assessment for complete wound closure. "Complete wound closure" will be defined as full epithelialization of the wound with the absence of drainage and lack of dressing requirement for an interval of at least 2 weeks.