NCT04755647

Nitric Oxide Footbath for Treatment of Diabetic Foot Ulcers

Safety & Efficacy of Topical Nitric Oxide Releasing Solution (NORS) Delivered as an Adjunctive Footbath Treatment as Compared to Placebo in the Management of Diabetic Foot Ulcers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Sanotize Research and Development corp. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety and effectiveness of a nitric oxide releasing solution, delivered as a footbath, to act as an antimicrobial treatment for participants presenting with a diabetic foot ulcer.

Detailed description

It is hypothesized that a single, relatively short exposure (three times a week for a half hour) of a nitric oxide releasing solution (NORS) for four (4) week period will be well tolerated and may have other beneficial secondary outcomes for individuals presenting with diabetic foot ulcers.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DRUG	Nitric Oxide-Releasing Solution	Active antimicrobial
DRUG	Saline solution, hypotonic	Placebo

Timeline

• Start date: 2021-02-23
• Primary completion: 2023-05-20
• Completion: 2023-05-20
• First posted: 2021-02-16
• Last updated: 2023-05-31

Locations

1 site across 1 country: Canada