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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06402565
The ClinicalTrials.gov registry entry for NCT06402565 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 254-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (84% lower). The listed sponsor is NOxy Health Products, which has 1 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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