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

This study has been terminated.
(Sponsor Decision)
Sponsor:
Information provided by:
CoMentis
ClinicalTrials.gov Identifier:
NCT00316537
First received: April 17, 2006
Last updated: August 7, 2007
Last verified: August 2007
  Purpose

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 Intervention Phase
Diabetic Foot Ulcers
Drug: ATG002 (study drug)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by CoMentis:

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.

Estimated Enrollment: 48
Study Start Date: October 2006
Study Completion Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316537

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

No publications provided

ClinicalTrials.gov Identifier: NCT00316537     History of Changes
Other Study ID Numbers: ATG002-121
Study First Received: April 17, 2006
Last Updated: August 7, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by CoMentis:
diabetes
foot ulcers
nicotine gel
wound healing

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

ClinicalTrials.gov processed this record on April 17, 2014