NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers

NCT06402565 | Recruiting Phase 1 FDA Drug

• 1 other identifier: NO-003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (2)

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

  Methemoglobin is measured using co-oximetry

  14 weeks

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

  Incidence and severity of treatment-emergent adverse events (TEAEs), including serious adverse events and adverse events resulting in permanent discontinuation of protocol-defined therapy

  16 weeks

Secondary Outcomes (6)

• Proportion of subjects with complete wound closure during the 12 weeks of the Treatment Phase

  12 weeks

• Wound Area Change (%) during the 12 weeks of the Treatment Phase

  12 weeks

• Wound volume change (%) during the 12 weeks of the Treatment Phase

  12 weeks

• Time to complete wound closure during the 12 weeks of the Treatment Phase

  12 weeks

• Proportion of subjects who do not develop an infection during the 12 weeks of the Treatment Phase

  12 weeks

Study Arms (2)

NOX1416 and SOC

EXPERIMENTAL

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.

Drug: NOX1416 and SOC

SOC (Standard of care)

ACTIVE COMPARATOR

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.

Procedure: SOC (Standard of care)

Interventions

NOX1416 and SOC DRUG

Topical Nitric Oxide

Also known as: ADVANOX

NOX1416 and SOC

SOC (Standard of care) PROCEDURE

SOC as provided in the Arm/Group description.

SOC (Standard of care)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening:
• Male or female subjects aged 18 to 80 years (inclusive) with Type 1 or Type 2 diabetes requiring treatment with oral medications and/or insulin replacement therapy
• Subject has a glycosylated hemoglobin, HbA1c ≤ 12%. Note: Prior documented HbA1c within the last 3 months of the Screening Visit is acceptable.
• Presence of at least one diabetic foot ulcer that meets all of the following criteria:
• A full-thickness ulcer of University of Texas Wound Classification (UTWCS) Grade IA or IIA
• At least 50% of the ulcer is located below the malleoli
• Ulcer size (area) is ≥ 1 cm2 and ≤ 10 cm2 (post-debridement at time of randomization)
• Unresponsive to standard ulcer care for ≥ 4 weeks (at time of screening)
• There is a minimum 1 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot, post-debridement)
• No exposed bone and no tunneling, undermining, or sinus tracts
• The index ulcer has a clean base and is free of necrotic debris at time of placement of treatment product.
• Index ulcer and/or index ulcer limb may have had prior infection, but infection(s) must be adequately treated and controlled as defined by IDSA Guidelines Grade level 1.
• Ulcer must be non-healing as defined as \< 25% reduction in size in response to standard of care during the two-week run-in Screening Period (between the first Screening Visit and Baseline) Note: Criterion 3(i) will be evaluated at the time of randomization. If the subject has more than one qualifying diabetic foot ulcer, the ulcer designated as the Target Ulcer will be at the discretion of the Investigator.
• Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg or an ABI between 0.7 and ≤ 1.3, or TBI of \>0.6 within 3 months of the first Screening Visit. The assessment may also be performed between SV1 and SV2.
• Subject does not smoke or use tobacco products.

You may not qualify if:

• Subjects meeting ANY of the following criteria at time of Screening will be excluded from enrollment:
• Ulcers with exposed bone or associated with osteomyelitis. Note: Osteomyelitis should be ruled out by clinical examination (probing of the wound) or X-ray findings, if necessary, by the Investigator.
• Subject has ulcers secondary to a disease other than diabetes, e.g., fungal ulcerations, malignant ulcerations, and ulcerations due to venous or arterial insufficiency, or due to hematological disorders, in the opinion of the Principal Investigator.
• Ulcer, which in the opinion of the Investigator, is suspicious for cancer.
• Subjects with a gangrenous or ischemic toe that may need to be amputated in the opinion of the Investigator.
• Body mass index (BMI) \> 40kg/m2
• Methemoglobin \> 5% at SV1
• Laboratory values at Screening of:
• Hemoglobin \< 8.5 g/dL
• White Blood Cells (WBC) \< 3.0 X 109 cells/L and \> 11 x 109 cells/L
• Liver function studies \[Total bilirubin, aspartate aminotransferase (AST) and alanine transaminase (ALT)\] \> 3x the upper limit of normal
• Albumin \< 2.5 g/dL
• Renal function studies \[Estimated Glomerular Filtration Rate\] \< 45
• Presence of any clinically significant medical condition(s) that, in the opinion of the Investigator, could interfere with wound healing, including but not limited to the following:
• Vasculitis or connective tissue disease

Sponsors & Collaborators

• NOxy Health Products, LLC: lead

Study Sites (2)

Prohealth Research Center

Doral, Florida, 33166, United States

RECRUITING

Family First Medical Research Center

Hialeah Gardens, Florida, 33016, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Lex Schindler

CONTACT

6827778778; lex@noxyhp.com

Timothy Jacobson

CONTACT

6502782032; tim@noxyhp.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluator-Blinded Study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A total of 40 subjects (25 in the treatment group and 15 in the control group) will be randomized to receive either NOX1416 + SOC or SOC alone.

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 7, 2024
• Study Start: March 25, 2025
• Primary Completion: November 30, 2025
• Study Completion: January 30, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)