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

Phase 2TerminatedNCT00316537

CoMentis48 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetic Foot Ulcers

Interventions

ATG002 (study drug)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Assessment of ulcer size as determined by weekly ulcer tracings

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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