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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Condition or disease	Intervention/treatment	Phase
Diabetic Foot Ulcers	Drug: ATG002 (study drug)	Phase 1; Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	48 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
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
Study Start Date :	October 2006
Actual Study Completion Date :	July 2007

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Assessment of ulcer size as determined by weekly ulcer tracings

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Alabama
SeniorCare, Alabama Geriatric Specialists
Homewood, Alabama, United States, 35209
United States, Arizona
Hope Research Institute
Phoenix, Arizona, United States, 85050
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
United States, California
Center for Clinical Research
Castro Valley, California, United States, 94546
University of San Diego Wound Treatment and Research Center
San Diego, California, United States, 92103
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Ankle and Foot Specialists of Atlanta
Lithonia, Georgia, United States, 30058
United States, Maryland
Crossroads Research, Inc.
Owings Mills, Maryland, United States, 21117
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
NewBridge Medical Research
Warren, Pennsylvania, United States, 16365
United States, Washington
Central Washington Podiatry Service
Yakima, Washington, United States, 98902
United States, Wisconsin
Aurora Health Care / Lukes Medical Center
Milwaukee, Wisconsin, United States, 53215

Sponsors and Collaborators

CoMentis

Investigators

Study Director:	Henry Hsu, MD	Athenagen, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00316537 History of Changes
Other Study ID Numbers:	ATG002-121
First Posted:	April 21, 2006
Last Update Posted:	August 9, 2007
Last Verified:	August 2007

Keywords provided by CoMentis:

diabetes; foot ulcers; nicotine gel; wound healing

Additional relevant MeSH terms:

Ulcer; Diabetic Foot; Foot Ulcer; Pathologic Processes; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases	Diabetic Neuropathies; Foot Diseases; Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action