NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers
Trial Parameters
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.
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: 1. 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 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 IA or IIA 2. At least 50% of the ulcer is located 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 ≥ 4 weeks (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