Diabetic Foot Ulcers
Conditions
Keywords
diabetes, foot ulcers, nicotine gel, wound healing
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.
Interventions
DRUGATG002 (study drug)
Sponsors
CoMentis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of ulcer size as determined by weekly ulcer tracings | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed