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

Stopped early · Phase 1/Phase 2

Conditions studied: Diabetic Foot Ulcers

In brief

The purpose of this study is to evaluate the safety and preliminary efficacy of low dose nicotine gel in patients with chronic diabetic ulcers

Key facts

Study ID: NCT00316537
Run by: CoMentis
People needed: 48
Starts: 2006-10-01
Expected to finish: 2007-07-01
Last updated by the study team: 2007-08-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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
NewBridge Medical Research — Warren, Pennsylvania, United States
Central Washington Podiatry Service — Yakima, Washington, United States
Aurora Health Care / Lukes Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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