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

Diabetic Foot Ulcers Clinical Trial

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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00316537
Study type Interventional
Source CoMentis
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date October 2006
Completion date July 2007
View Details
See also
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