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NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers — NTCDU  

Diabetic Foot Ulcer Clinical Trial

Official title:
A Randomized, Controlled, Evaluator-Blinded Study to Assess the Safety and Efficacy of NOX1416 in the Treatment of Chronic, Non-Healing, Diabetic Foot Ulcers

Clinical Trial Summary

The goal of this multi-center, randomized, placebo-controlled, evaluator-blinded study is to assess the safety and efficacy of NOX1416 in the treatment of chronic, non-healing, diabetic foot ulcers (DFUs). Subjects will be randomized to receive treatment with NOX1416 or placebo, as an adjunct to Standard of Care (SOC). The primary objective of the study is to demonstrate the safety and tolerability of NOX1416 as adjunct to SOC. The secondary objective is to evaluate the clinical benefit of daily NOX1416, as an adjunct to standard of care SOC. Each site will assign a physician (or designee) to serve as the blinded evaluator who is responsible for assessing the study endpoints. The blinded evaluator will not be involved in the clinical care of subjects.

Clinical Trial Description

A total of 40 subjects (25 in the treatment group and 15 in the control group) will be randomized to receive either NOX1416 plus SOC or Placebo plus SOC. NOX1416 is a foam based gaseous nitric oxide (NO) product where NO is delivered topically through a microbubble foam. One pump each of Solution A (0.3g, containing citric acid and Solution B (0.3g, containing sodium nitrite) will be dispensed, mixed for five seconds and applied immediately per each square centimeter of wound area using any sterile applicator. NOX1416 is left on the wound bed for a 5-minute period, then removed with a sterile gauze, and the standard of care dressing applied. Subjects randomized to the NOX1416 treatment group will receive once a day application, for a total of 12 weeks with a double treatment 10 minutes apart, on the first day. Similar to the NOX1416 treatment schedule, placebo will be topically applied directly onto the wound bed and left on the wound bed for a 5-minute period, removed, and the SOC dressing applied. Subjects randomized to the control group will receive once a day application for a total of 12 weeks, with a double treatment, 10 minutes apart, on the first day. Standard of care will include evaluation to document, offloading, adequate arterial flow, wound cleansing, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of a moist wound environment, and management of infection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06402565
Study type Interventional
Source NOxy Health Products, LLC
Contact Rhonda Sullivan, DNP, PhD
Phone 9045107438
Email rhonda@noxyhp.com
Status Recruiting
Phase Phase 1
Start date May 23, 2024
Completion date June 30, 2025
View Details
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