NCT06402565
NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers
Active, Not Recruiting
PHASE1Ages 18–80InterventionalTreatmentNOxy Health Products, LLC
~40 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:NOX1416 and SOCSOC (Standard of care)
At a glance
Recruiting sites
0 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of subjects with a Methemoglobin >5% at any assessment point
Measured over 14 weeks
+1 more outcome measured
Conditions
Where it's being run
13 sites across 5 statesFlorida6
Texas3
Arizona2
Massachusetts1
Ohio1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Exclusion
Hemoglobin \< 8.5 g/dL
White Blood Cells (WBC) \< 3.0 X 109 cells/L and \> 11 x 109 cells/L
Liver function studies \[Total bilirubin, aspartate aminotransferase (AST) and alanine transaminase (ALT)\] \> 3x the upper limit of normal
Albumin \< 2.5 g/dL
Renal function studies \[Estimated Glomerular Filtration Rate\] \< 45 8. Presence of any clinically significant medical condition(s) that, in the opinion of the Investigator, could interfere with wound healing, including but not limited to the following:
Vasculitis or connective tissue disease
Buerger's disease, Raynaud's or other peripheral vascular disease.
Clinically significant claudication or peripheral edema on the affected limb
Acute or unstable Charcot foot
Aplastic anemia or sickle cell anemia
Current sepsis 9. Past or present malignancy below the knee on the same limb as the Target Ulcer; 10. History of radiation at the Target Ulcer site. 11. Subject is currently receiving (i.e., within 30 days of T1 visit) or scheduled to receive any of following medication or therapies during the course of the study.
Immunosuppressants (including chronic systemic corticosteroids)
Cytotoxic chemotherapy
Cytostatic therapy
Lower limb revascularization surgery (e.g., angioplasty, artery bypass surgery,)
application of bioengineered tissue or skin substitutes
use of any investigational drug(s) 12. Subjects who have previously received NOX1416 treatment 13. Subject is unable to comply with offloading device. 14. Revascularization surgery on the lower extremity on which the index ulcer is located within 30 days of Screening Visit (SV1). 15. Has a known hypersensitivity to any of the investigational drug components 16. Subject is susceptible to hemorrhaging or has a congenital or acquired predisposition to hemorrhaging. 17. Subject has a history of self-harm or suicidal ideation. 18. Any reason that the subjects may need to be admitted to inpatient acute care in the opinion of the Investigator. 19. Has any other factor which may, in the opinion of the investigator, compromise participation and/or follow-up in the study.
What this trial measures
- Number of subjects with a Methemoglobin >5% at any assessment point14 weeks
Methemoglobin is measured using co-oximetry
- Incidence and severity of treatment-emergent adverse events (TEAEs)16 weeks
Incidence and severity of treatment-emergent adverse events (TEAEs), including serious adverse events and adverse events resulting in permanent discontinuation of protocol-defined therapy