NCT00316537

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

A Multicenter, Randomized Study of the Safety and Preliminary Efficacy of Low-Dose Nicotine Gel (ATG002) in Patients With Plantar Diabetic Foot Ulcers

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: CoMentis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
DRUG	ATG002 (study drug)

Timeline

• Start date: 2006-10-01
• Completion: 2007-07-01
• First posted: 2006-04-21
• Last updated: 2007-08-09

Locations

13 sites across 1 country: United States