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

NCT ID: NCT00316537

Last Updated: 2007-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-07-31

Brief Summary

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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

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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

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Diabetic Foot Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ATG002 (study drug)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CoMentis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Henry Hsu, MD

Role: STUDY_DIRECTOR

Athenagen, Inc.

Locations

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SeniorCare, Alabama Geriatric Specialists

Homewood, Alabama, United States

Site Status

Hope Research Institute

Phoenix, Arizona, United States

Site Status

Southern Arizona VA Health Care System

Tucson, Arizona, United States

Site Status

Center for Clinical Research

Castro Valley, California, United States

Site Status

University of San Diego Wound Treatment and Research Center

San Diego, California, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Ankle and Foot Specialists of Atlanta

Lithonia, Georgia, United States

Site Status

Crossroads Research, Inc.

Owings Mills, Maryland, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

NewBridge Medical Research

Warren, Pennsylvania, United States

Site Status

Central Washington Podiatry Service

Yakima, Washington, United States

Site Status

Aurora Health Care / Lukes Medical Center

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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ATG002-121

Identifier Type: -

Identifier Source: org_study_id