NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers (NTCDU)

Summary

The goal of this multi-center,randomized, placebo controlled, evaluator-blinded study is to assess the efficacy and safety 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 SOC. The primary objective of the study is to evaluate the clinical benefit of daily NOX1416, as an adjunct to standard of care (SOC), in the treatment of chronic, non-healing DFUs. The secondary objective is to demonstrate efficacy, safety and tolerability of NOX1416 as adjunct to SOC. Each site will assign a physician (or designee) to serve as the "blinded-evaluator" to be responsible for assessing the study endpoints such as wound measurements and complete wound closure. The blinded-evaluator will not be involved in the clinical care of the subject.

Timeline

Start

2023-08-16

Primary completion

2024-09

Completion

2024-11-24

Outcome

Outcome not reported

Stopped (Enrollment): “The NO-002 study had to be paused because of enrollment disruptions due to the current situation in Israel, and concerns over the placebo batch stability results.”

Drugs

Indications