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NCT06402565 · ClinicalTrials.gov registry record · Phase 1
NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers
A Phase 1 study of Diabetic Foot Ulcer, sponsored by NOxy Health Products.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT06402565: Recruiting Phase 1 study of Diabetic Foot Ulcer, sponsored by NOxy Health Products.
NCT06402565 is a Phase 1 study of Diabetic Foot Ulcer that is actively recruiting participants, run by NOxy Health Products. The registered enrollment target is 40 participants, below the 254-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06402565, a Phase 1 study of Diabetic Foot Ulcer, is actively recruiting participants, sponsored by NOxy Health Products.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Methemoglobin is measured using co-oximetry
Conditions Studied
Interventions
- DRUG NOX1416 and SOC
- PROCEDURE SOC (Standard of care)
Study Locations (2)
Florida
- Prohealth Research Center - Doral
- Family First Medical Research Center - Hialeah Gardens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-03-25 |
| Est. Completion | 2026-01-30 |
| Phase | Phase 1 |
What NCT06402565 shows while recruiting
NCT06402565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 254-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 2 interventions - of which NOX1416 and SOC is the first listed.
NCT06402565 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06402565 about?
NCT06402565 is a clinical study titled "NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers". 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 w...
What is the current status of trial NCT06402565?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2025-03-25. Estimated completion is 2026-01-30.
What conditions does trial NCT06402565 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer.
What interventions are being tested in trial NCT06402565?
The interventions under investigation include: NOX1416 and SOC (DRUG), SOC (Standard of care) (PROCEDURE).
Who is sponsoring clinical trial NCT06402565?
This trial is sponsored by NOxy Health Products, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06402565 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Foot Ulcer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06402565's enrollment target sits among peer trials
40 52nd of 67 higher than 15 of 67 other Diabetic Foot Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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