NCT06402565

NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: NOxy Health Products, LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this multi-center, randomized, controlled, evaluator-blinded study is to assess and measure the safety and efficacy of NOX1416 as an adjunct to standard of care (SOC) in the treatment of chronic, non-healing, diabetic foot ulcers (DFUs). Subjects will be randomized to receive treatment with NOX1416 as an adjunct to Standard of Care (SOC) or SOC alone. The primary objective of the study is to demonstrate the safety and tolerability of NOX1416 as adjunct to SOC. The secondary objective of the study is to evaluate the clinical benefit of daily NOX1416, as an adjunct to SOC, in the treatment of chronic, non-healing diabetic foot ulcers. The study will use a centralized blinded assessor. The blinded assessor will be responsible for assessing the efficacy endpoints such as wound measurements and complete wound closure. The blinded assessor will not be involved in the clinical care of the subject.

Detailed 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 SOC alone. 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 and mixed upon depression of the wye nozzle dispenser, and then applied immediately per each square centimeter of wound area using any sterile applicator. NOX1416 is topically applied directly onto the wound bed and left on the wound bed for a 5-minute period then rinsed off or wiped off with a wet, sterile cloth. 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. Subjects randomized to the control group will receive standard of care, alone. 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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DRUG	NOX1416 and SOC	Topical Nitric Oxide
PROCEDURE	SOC (Standard of care)	SOC as provided in the Arm/Group description.

Timeline

• Start date: 2025-03-25
• Primary completion: 2025-11-30
• Completion: 2026-01-30
• First posted: 2024-05-07
• Last updated: 2025-04-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study