NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers (NCT06402565) | Clinical Trial Compass
RecruitingPhase 1
NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers
United States40 participantsStarted 2025-03-25
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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)
Exclusion criteria
✕
What they're measuring
1
Number of subjects with a Methemoglobin >5% at any assessment point
Timeframe: 14 weeks
2
Incidence and severity of treatment-emergent adverse events (TEAEs)
. 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:
✕. 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: