NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers
Public ClinicalTrials.gov record NCT06402565. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Controlled, Evaluator-Blinded Study to Assess the Safety and Efficacy of NOX1416 in the Treatment of Chronic, Non-Healing, Diabetic Foot Ulcers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06402565
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 6, 2024 (Actual)
- Primary completion
- Jun 14, 2026 (Estimated)
- Completion
- Jun 30, 2026 (Estimated)
- Last update posted
- May 20, 2026
2024 – 2026
United States locations
- U.S. sites
- 13
- U.S. states
- 5
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Foot Care | Phoenix | Arizona | 85053 | — |
| AFC - Tucson | Tucson | Arizona | 85718 | — |
| Solutions Medical Research | Coral Gables | Florida | 33134 | — |
| Prohealth Research Center | Doral | Florida | 33166 | — |
| Betancourt Research Services | Doral | Florida | 33172 | — |
| Family First Medical Research Center | Hialeah Gardens | Florida | 33016 | — |
| Symphony | Palm Harbor | Florida | 34684 | — |
| Avita Clinical Research | Tampa | Florida | 33613 | — |
| Clinical Trials of New England | Hyde Park | Massachusetts | 02136 | — |
| Cutting Edge | Circleville | Ohio | 43113 | — |
| IntraCare Clinical | Dallas | Texas | 75254 | — |
| New Dawn Wellness and Medical Center | Houston | Texas | 77082 | — |
| RITE Clinicals | Shenandoah | Texas | 77429 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06402565, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 20, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06402565 live on ClinicalTrials.gov.