Status:
TERMINATED
Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers
Lead Sponsor:
CoMentis
Conditions:
Diabetic Foot Ulcers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- Patients who use tobacco in any form or who are on nicotine replacement therapy
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00316537
Start Date
October 1 2006
End Date
July 1 2007
Last Update
August 9 2007
Active Locations (13)
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1
SeniorCare, Alabama Geriatric Specialists
Homewood, Alabama, United States, 35209
2
Hope Research Institute
Phoenix, Arizona, United States, 85050
3
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
4
Center for Clinical Research
Castro Valley, California, United States, 94546