Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers
- Conditions
- Diabetic Foot Ulcers
- Registration Number
- NCT00316537
- Lead Sponsor
- CoMentis
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 48
- 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.
- Patients who use tobacco in any form or who are on nicotine replacement therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Assessment of ulcer size as determined by weekly ulcer tracings
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (13)
SeniorCare, Alabama Geriatric Specialists
🇺🇸Homewood, Alabama, United States
Hope Research Institute
🇺🇸Phoenix, Arizona, United States
Southern Arizona VA Health Care System
🇺🇸Tucson, Arizona, United States
Center for Clinical Research
🇺🇸Castro Valley, California, United States
University of San Diego Wound Treatment and Research Center
🇺🇸San Diego, California, United States
University of Miami
🇺🇸Miami, Florida, United States
Ankle and Foot Specialists of Atlanta
🇺🇸Lithonia, Georgia, United States
Crossroads Research, Inc.
🇺🇸Owings Mills, Maryland, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Scroll for more (3 remaining)SeniorCare, Alabama Geriatric Specialists🇺🇸Homewood, Alabama, United States