Study Stopped
Sponsor Decision
Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers
A Multicenter, Randomized Study of the Safety and Preliminary Efficacy of Low-Dose Nicotine Gel (ATG002) in Patients With Plantar Diabetic Foot Ulcers
1 other identifier
interventional
48
1 country
13
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2006
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2006
CompletedFirst Posted
Study publicly available on registry
April 21, 2006
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedAugust 9, 2007
August 1, 2007
April 17, 2006
August 7, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of ulcer size as determined by weekly ulcer tracings
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients who use tobacco in any form or who are on nicotine replacement therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CoMentislead
Study Sites (13)
SeniorCare, Alabama Geriatric Specialists
Homewood, Alabama, 35209, United States
Hope Research Institute
Phoenix, Arizona, 85050, United States
Southern Arizona VA Health Care System
Tucson, Arizona, 85723, United States
Center for Clinical Research
Castro Valley, California, 94546, United States
University of San Diego Wound Treatment and Research Center
San Diego, California, 92103, United States
University of Miami
Miami, Florida, 33136, United States
Ankle and Foot Specialists of Atlanta
Lithonia, Georgia, 30058, United States
Crossroads Research, Inc.
Owings Mills, Maryland, 21117, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
NewBridge Medical Research
Warren, Pennsylvania, 16365, United States
Central Washington Podiatry Service
Yakima, Washington, 98902, United States
Aurora Health Care / Lukes Medical Center
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Henry Hsu, MD
Athenagen, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 17, 2006
First Posted
April 21, 2006
Study Start
October 1, 2006
Study Completion
July 1, 2007
Last Updated
August 9, 2007
Record last verified: 2007-08