Actively Recruiting
NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers
Led by NOxy Health Products, LLC · Updated on 2025-04-02
40
Participants Needed
2
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 80 years with type 1 or type 2 diabetes treated with oral medications and/or insulin
- HbA1c less than or equal to 12% within the last 3 months
- At least one diabetic foot ulcer meeting all: full-thickness Grade IA or IIA, at least 50% below the malleoli, size between 1 cm2 and 10 cm2 post-debridement, unhealed after 4 weeks of standard care, clean base without necrotic debris, no exposed bone or tunneling, and at least 1 cm from other ulcers
- Adequate blood circulation to the affected foot as shown by specific oxygen or blood flow measurements within 3 months
- Non-smoker, no tobacco use
- Negative pregnancy test if female of childbearing potential, not breastfeeding, and willing to use contraception
- Able and willing to comply with study procedures and dressing changes
- Cognitive and physical ability to apply treatment or have a caregiver able to do so
- Ulcer has been offloaded with an approved device for at least 14 days prior to randomization
- Signed informed consent obtained
You will not qualify if you...
- Ulcers with exposed bone or osteomyelitis
- Ulcers caused by diseases other than diabetes (e.g., fungal, malignant, venous or arterial insufficiency)
- Ulcers suspected to be cancerous
- Gangrenous or ischemic toes likely needing amputation
- Body mass index over 40 kg/m2
- Methemoglobin level over 5% at screening
- Low hemoglobin, abnormal white blood cell count, elevated liver enzymes, low albumin, or poor kidney function based on lab tests
- Medical conditions that may interfere with wound healing, including certain vascular diseases, unstable Charcot foot, anemia, or sepsis
- Past or present malignancy below the knee on the same limb as the ulcer
- History of radiation treatment at the ulcer site
- Recent use or planned use of immunosuppressants, chemotherapy, revascularization surgery, bioengineered tissue, or investigational drugs
- Previous NOX1416 treatment
- Inability to comply with offloading devices
- Recent lower limb revascularization surgery within 30 days
- Known allergy to study drug components
- Risk of bleeding or bleeding disorders
- History of self-harm or suicidal thoughts
- Conditions requiring inpatient acute care or other factors compromising participation or follow-up
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Prohealth Research Center
Doral, Florida, United States, 33166
Actively Recruiting
2
Family First Medical Research Center
Hialeah Gardens, Florida, United States, 33016
Actively Recruiting
Research Team
L
Lex Schindler
CONTACT
T
Timothy Jacobson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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