Clinical trial NCT00316537: Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Diabetic Foot Ulcers
Keywords: diabetes
foot ulcers
nicotine gel
wound healing
Lead sponsor: CoMentis
Sponsor class: INDUSTRY
First posted: 2006-04-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Assessment of ulcer size as determined by weekly ulcer tracings
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: Homewood
country: United States
facility: SeniorCare, Alabama Geriatric Specialists
state: Alabama
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Castro Valley
country: United States
facility: Center for Clinical Research
state: California
city: San Diego
country: United States
facility: University of San Diego Wound Treatment and Research Center
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Lithonia
country: United States
facility: Ankle and Foot Specialists of Atlanta
state: Georgia
city: Owings Mills
country: United States
facility: Crossroads Research, Inc.
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Warren
country: United States
facility: NewBridge Medical Research
state: Pennsylvania
city: Yakima
country: United States
facility: Central Washington Podiatry Service
state: Washington
city: Milwaukee
country: United States
facility: Aurora Health Care / Lukes Medical Center
state: Wisconsin
Study officials:
affiliation: Athenagen, Inc.
name: Henry Hsu, MD
role: STUDY_DIRECTOR
References: