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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00316537
Other study ID # ATG002-121
Secondary ID
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
Est. primary completion date
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


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.
See also
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