Trial | NCT00316537  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    nicotine ...

  • Study Participants

    48
The purpose of this study is to evaluate the safety and preliminary efficacy of low dose nicotine gel in patients with chronic diabetic ulcers
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.
Study Started
Oct 31
2006
Study Completion
Jul 31
2007
Last Update
Aug 09
2007
Estimate

Drug ATG002 (study drug)

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
No Results Posted