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NOX1416 for Diabetic Foot Ulcers (NTCDU Trial)

Phase 1

Recruiting

Led By Thomas Serena, MD

Research Sponsored by NOxy Health Products, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is able and willing to comply with study procedures and applicable dressing changes

Presence of at least one diabetic foot ulcer meeting specific criteria including size, location, depth, and response to standard care

Must not have

Ulcers with exposed bone or associated with osteomyelitis

Susceptibility to hemorrhaging or predisposition to hemorrhaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 weeks

Summary

This trial will assess the safety and effectiveness of a treatment called NOX1416 for chronic diabetic foot ulcers. Participants will be randomly assigned to receive either NOX1416 or a placebo in addition

Who is the study for?

This trial is for individuals with chronic, non-healing diabetic foot ulcers. Participants should be adults who have had a foot ulcer for an extended period without improvement. They must be able to receive standard care treatments alongside the trial medication or placebo.

What is being tested?

The study tests NOX1416's safety and effectiveness in healing diabetic foot ulcers compared to a placebo, both used with standard wound care. Patients are randomly chosen to get either NOX1416 or a fake drug (placebo) without knowing which one they're getting.

What are the potential side effects?

While specific side effects of NOX1416 aren't listed, common risks may include irritation at the application site, allergic reactions, or infection. The study aims to confirm these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing and able to follow the study's procedures and dressing changes.

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I have a diabetic foot ulcer that fits certain size, location, and depth criteria.

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My blood flow in the affected limb is confirmed to be adequate by an ABI test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have ulcers with exposed bone or infection in the bone.

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I am prone to bleeding easily.

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I have ulcers not caused by diabetes.

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I have an ulcer that may be cancerous or needs amputation.

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I have health issues that could affect how my wounds heal.

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I am currently taking or will start taking certain medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and severity of treatment-emergent adverse events (TEAEs)

Number of subjects with a Methemoglobin >5% at any assessment point

Secondary study objectives

Change in appearance of urine from baseline to subsequent scheduled visits

Change in color of urine from baseline to subsequent scheduled visits

Change in microscopic examination of urine specimens from baseline to subsequent scheduled visits

+51 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NOX1416 and SOCExperimental Treatment1 Intervention

NOX1416 is a foam based gaseous nitric oxide (NO) product that will be topically applied directly onto the wound bed and left on the wound bed for a 5-minute period. 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. 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.

Group II: Placebo and SOCPlacebo Group1 Intervention

Placebo is topically applied directly onto the wound bed and left on the wound bed for a 5-minute period. Subjects randomized to the control group will receive once a day application, fora 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.

0 / 9Eligibility criteria met