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 Details — Status: Terminated

Administrative data

• NCT number: NCT00316537
• Other study ID #: ATG002-121
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: April 17, 2006
• Last updated: August 7, 2007
• Start date: October 2006
• Est. completion date: July 2007

Study information

• Verified date: August 2007
• Source: CoMentis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

Drug:
• ATG002 (study drug)

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Center for Clinical Research	Castro Valley	California
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	SeniorCare, Alabama Geriatric Specialists	Homewood	Alabama
United States	Ankle and Foot Specialists of Atlanta	Lithonia	Georgia
United States	University of Miami	Miami	Florida
United States	Aurora Health Care / Lukes Medical Center	Milwaukee	Wisconsin
United States	Crossroads Research, Inc.	Owings Mills	Maryland
United States	Hope Research Institute	Phoenix	Arizona
United States	University of San Diego Wound Treatment and Research Center	San Diego	California
United States	Southern Arizona VA Health Care System	Tucson	Arizona
United States	NewBridge Medical Research	Warren	Pennsylvania
United States	Central Washington Podiatry Service	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
CoMentis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of ulcer size as determined by weekly ulcer tracings
Secondary	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.