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

CoMentis

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Diabetic Foot Ulcers

Treatments: Drug: ATG002 (study drug)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00316537

ATG002-121

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind