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

August 7, 2007 updated by: CoMentis

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

The purpose of this study is to evaluate the safety and preliminary efficacy of low dose nicotine gel in patients with chronic diabetic ulcers

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Assessment of ulcer size as determined by weekly ulcer tracings

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CoMentis

Investigators

  • Study Director: Henry Hsu, MD, Athenagen, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

April 17, 2006

First Submitted That Met QC Criteria

April 17, 2006

First Posted (Estimate)

April 21, 2006

Study Record Updates

Last Update Posted (Estimate)

August 9, 2007

Last Update Submitted That Met QC Criteria

August 7, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATG002-121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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