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

NCT06020664 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-01-16

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer

Interventions

DRUG

NOX-1416+SOC

NOX1416+SOC as provided in Arm/group description

OTHER

Placebo+SOC

Placebo+SOC as provided in Arm/group description

Sponsors & Collaborators

  • NOxy Health Products, LLC

    lead INDUSTRY

Principal Investigators

  • Gabriel Halperin, MD · Mission Community Hospital, CA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-16
Primary Completion
2024-09-30
Completion
2024-11-24

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06020664 on ClinicalTrials.gov