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

Primary Purpose

Diabetic Foot Ulcers

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ATG002 (study drug)
Sponsored by
CoMentis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcers focused on measuring diabetes, foot ulcers, nicotine gel, wound healing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SeniorCare, Alabama Geriatric Specialists
  • Hope Research Institute
  • Southern Arizona VA Health Care System
  • Center for Clinical Research
  • University of San Diego Wound Treatment and Research Center
  • University of Miami
  • Ankle and Foot Specialists of Atlanta
  • Crossroads Research, Inc.
  • Beth Israel Deaconess Medical Center
  • University of North Carolina at Chapel Hill
  • NewBridge Medical Research
  • Central Washington Podiatry Service
  • Aurora Health Care / Lukes Medical Center

Outcomes

Primary Outcome Measures

Assessment of ulcer size as determined by weekly ulcer tracings

Secondary Outcome Measures

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.

Full Information

First Posted
April 17, 2006
Last Updated
August 7, 2007
Sponsor
CoMentis
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1. Study Identification

Unique Protocol Identification Number
NCT00316537
Brief Title
Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers
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 Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Terminated
Why Stopped
Sponsor Decision
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CoMentis

4. Oversight

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers
Keywords
diabetes, foot ulcers, nicotine gel, wound healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ATG002 (study drug)
Primary Outcome Measure Information:
Title
Assessment of ulcer size as determined by weekly ulcer tracings
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Hsu, MD
Organizational Affiliation
Athenagen, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
SeniorCare, Alabama Geriatric Specialists
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Hope Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Southern Arizona VA Health Care System
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Center for Clinical Research
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
University of San Diego Wound Treatment and Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Ankle and Foot Specialists of Atlanta
City
Lithonia
State/Province
Georgia
ZIP/Postal Code
30058
Country
United States
Facility Name
Crossroads Research, Inc.
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
NewBridge Medical Research
City
Warren
State/Province
Pennsylvania
ZIP/Postal Code
16365
Country
United States
Facility Name
Central Washington Podiatry Service
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
Aurora Health Care / Lukes Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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