A Randomized, Controlled, Evaluator-Blinded Study to Assess the Safety and Efficacy of NOX1416 in the Treatment of Chronic, Non-Healing, Diabetic Foot Ulcers
Overview
- Phase
- Phase 1
- Intervention
- NOX1416 and SOC
- Conditions
- Diabetic Foot Ulcer
- Sponsor
- NOxy Health Products, LLC
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Number of subjects with a Methemoglobin >5% at any assessment point
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
NOX1416 and SOC
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.
Intervention: NOX1416 and SOC
SOC (Standard of care)
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.
Intervention: SOC (Standard of care)
Outcomes
Primary Outcomes
Number of subjects with a Methemoglobin >5% at any assessment point
Time Frame: 14 weeks
Methemoglobin is measured using co-oximetry
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time Frame: 16 weeks
Incidence and severity of treatment-emergent adverse events (TEAEs), including serious adverse events and adverse events resulting in permanent discontinuation of protocol-defined therapy
Secondary Outcomes
- 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)
- Changes in Wound-Q Health-Related Quality of Life (Life Impact Psychological, Social) scores during the 12 weeks of the Treatment Phase(12 weeks)