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NCT06402565 | NOT YET RECRUITING | Diabetic Foot Ulcer

NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers
Sponsor:

NOxy Health Products, LLC

Brief 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.

Condition or disease

Diabetic Foot Ulcer

Intervention/treatment

NOX1416 plus SOC

Placebo plus SOC

Phase

PHASE1

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 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 Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : SINGLE
Masking Description : Evaluator-Blinded Study
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-11-30
Estimated Primary Completion Date : 2025-11-30
Estimated Study Completion Date : 2026-01-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • Subjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening
    • 1. Male or female subjects aged 18 to 80 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control.
    • 2. Subject has a glycosylated hemoglobin, HbA1c ≤ 12%. Note: Prior documented HbA1c within the last 3 months of the Screening Visit is acceptable.
    • 3. Presence of at least one diabetic foot ulcer that meets all of the following criteria
      • 1. A full-thickness ulcer of University of Texas Wound Classification (UTWCS) Grade I or II
      • 2. Ulcer is located on or below the malleoli
      • 3. Ulcer size (area) is ≥ 1 cm2 and ≤ 10 cm2 (post-debridement at time of randomization)
      • 4. Unresponsive to standard ulcer care for ≥3 months (at time of screening)
      • 5. There is a minimum 1 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot, post-debridement)
      • 6. No exposed bone and no tunneling, undermining, or sinus tracts
      • 7. 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(g) 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.
      • 4. Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) ≥ 0.6 and ≤ 1.2. ABI results within the last 3 months of Screening are acceptable. The assessment may also be performed between SV1 and SV2. Note: If the ABI measurement is \>1.20, confirmatory tests (Great toe pressure and/or TcPO2 at the foot) will be performed. A subject will be considered eligible for inclusion in this study if Great toe pressure ≥ 40mmHg or TcPO2 ≥ 40 mmHg at the foot. Prior documented flow study within the last 3 months of the Screening Visit is acceptable.
      • 5. Subject does not smoke or use tobacco products.
      • 6. Subject, if female of child-bearing potential, has a negative serum pregnancy test at screening, must not be breastfeeding, and willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) throughout the study.
      • 7. Subject is able and willing to comply with study procedures and applicable dressing changes.
      • 8. Subject demonstrates cognitive and physical ability to administer the treatment as determined by the clinician. If a caregiver will administer the treatment, the caregiver must demonstrate cognitive and physical ability.
      • 9. A signed and dated informed consent form has been obtained from the subject.
      Exclusion Criteria
      • Subjects meeting ANY of the following criteria at time of Screening will be excluded from enrollment
        • 1. 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.
        • 2. 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.
        • 3. Ulcer, which in the opinion of the Investigator is suspicious for cancer. Note: Ulcers present for \> 6 months would require biopsy to be performed to rule out malignancy
        • 4. Subjects with a gangrenous or ischemic toe that may need to be amputated in the opinion of the Investigator.
        • 5. Current smoker or tobacco product user
        • 6. Body mass index (BMI) \> 40kg/m2
        • 7. Methemoglobin \> 5% at SV1
        • 8. Laboratory values at Screening of
          • 1. Hemoglobin \< 8.5 g/dL
          • 2. White Blood Cells (WBC) \< 3.0 X 109 cells/L and \> 11 x 109 cells/L
          • 3. Liver function studies \[Total bilirubin, aspartate aminotransferase (AST) and alanine transaminase (ALT)\] \> 3x the upper limit of normal
          • 4. Albumin \< 2.5 g/dL
          • 5. Renal function studies \[Estimated Glomerular Filtration Rate\] \< 45
          • 9. 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
            • 1. Vasculitis or connective tissue disease
            • 2. Buerger's disease, Raynaud's or other peripheral vascular disease.
            • 3. Clinically significant claudication or peripheral edema on the affected limb
            • 4. Acute or unstable Charcot foot
            • 5. Aplastic anemia or sickle cell anemia
            • 6. Current sepsis
            • 7. Severe heart diseases such as congestive heart failure (NYHA Class III or IV), coronary heart disease with ST segment elevation, myocardial infarction, or coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the last 6 months
            • 8. Severe liver disease
            • 9. End-stage renal disease
            • 10. Severe malnutrition
            • 11. Immunosuppression
            • 12. Acquired immune deficiency syndrome (AIDS) or HIV positive
            • 13. Past or present malignancy below the knee on the same limb as the Target Ulcer;
            • 14. History of radiation at the Target Ulcer site.
            • 10. Subject is currently receiving (i.e., within 30 days of T1 visit) or scheduled to receive any of following medication or therapies during the course of the study.
            • 1. Immunosuppressants (including chronic systemic corticosteroids)
            • 2. Cytotoxic chemotherapy
            • 3. Cytostatic therapy
            • 4. Lower limb revascularization surgery (e.g., angioplasty, artery bypass surgery,)
            • 5. application of bioengineered tissue or skin substitutes
            • 6. use of any investigational drug(s)
            • 11. Subjects who have previously received NOX1416 treatment
            • 12. Has a known hypersensitivity to any of the investigational drug components
            • 13. Subject is susceptible to hemorrhaging or has a congenital or acquired predisposition to hemorrhaging.
            • 14. Any reason that the subjects may need to be admitted to inpatient acute care in the opinion of the Investigator.
            • 15. Has any other factor which may, in the opinion of the investigator, compromise participation and/or follow-up in the study.
NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers

Location Details

NCT06402565

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