Diabetic Foot UlcerPhase 1NTCDUNCT06402565
NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers
A Phase 1 study testing NOX1416 and SOC in people with Diabetic Foot Ulcer, run by NOxy Health Products, LLC at 13 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- NOX1416 and SOC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 13 sitesUnited States
- Study dates
- 6 Jun 2024to 30 Jun 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening:
- Male or female subjects aged 18 to 80 years (inclusive) with Type 1 or Type 2 diabetes requiring treatment with oral medications and/or insulin replacement therapy
- Subject has a glycosylated hemoglobin, HbA1c ≤ 12%. Note: Prior documented HbA1c within the last 3 months of the Screening Visit is acceptable.
- Presence of at least one diabetic foot ulcer that meets all of the following criteria:
- A full-thickness ulcer of University of Texas Wound Classification (UTWCS) Grade IA or IIA
- At least 50% of the ulcer is located below the malleoli
Show all 20Show fewer
- Ulcer size (area) is ≥ 1 cm2 and ≤ 10 cm2 (post-debridement at time of randomization)
- Unresponsive to standard ulcer care for ≥ 4 weeks (at time of screening)
- There is a minimum 1 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot, post-debridement)
- No exposed bone and no tunneling, undermining, or sinus tracts
- The index ulcer has a clean base and is free of necrotic debris at time of placement of treatment product.
- Index ulcer and/or index ulcer limb may have had prior infection, but infection(s) must be adequately treated and controlled as defined by IDSA Guidelines Grade level 1.
- Ulcer must be non-healing as defined as < 25% reduction in size in response to standard of care during the two-week run-in Screening Period (between the first Screening Visit and Baseline) Note: Criterion 3(i) will be evaluated at the time of randomization. If the subject has more than one qualifying diabetic foot ulcer, the ulcer designated as the Target Ulcer will be at the discretion of the Investigator.
- Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg or an ABI between 0.7 and ≤ 1.3, or TBI of >0.6 within 3 months of the first Screening Visit. The assessment may also be performed between SV1 and SV2.
- Subject does not smoke or use tobacco products.
- Subject, if female of child-bearing potential, has a negative urine pregnancy test at screening, must not be breastfeeding, and willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) throughout the study.
- Subject is able and willing to comply with study procedures and applicable dressing changes.
- Subject demonstrates cognitive and physical ability to administer the treatment as determined by the clinician. If a caregiver will administer the treatment, the caregiver must demonstrate cognitive and physical ability.
- The index ulcer has been offloaded with protocol defined offloading device throughout the study run-in period for at least 14 days prior to randomization (Run- in period defined as Screening through TV1/Randomization).
- A signed and dated informed consent form has been obtained from the subject.
Who cannot join
- Subjects meeting ANY of the following criteria at time of Screening will be excluded from enrollment:
- Ulcers with exposed bone or associated with osteomyelitis. Note: Osteomyelitis should be ruled out by clinical examination (probing of the wound) or X-ray findings, if necessary, by the Investigator.
- Subject has ulcers secondary to a disease other than diabetes, e.g., fungal ulcerations, malignant ulcerations, and ulcerations due to venous or arterial insufficiency, or due to hematological disorders, in the opinion of the Principal Investigator.
- Ulcer, which in the opinion of the Investigator, is suspicious for cancer.
- Subjects with a gangrenous or ischemic toe that may need to be amputated in the opinion of the Investigator.
- Body mass index (BMI) > 40kg/m2
Show all 37Show fewer
- Methemoglobin > 5% at SV1
- Laboratory values at Screening of:
- 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
- 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
- Past or present malignancy below the knee on the same limb as the Target Ulcer;
- History of radiation at the Target Ulcer site.
- 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)
- Subjects who have previously received NOX1416 treatment
- Subject is unable to comply with offloading device.
- Revascularization surgery on the lower extremity on which the index ulcer is located within 30 days of Screening Visit (SV1).
- Has a known hypersensitivity to any of the investigational drug components
- Subject is susceptible to hemorrhaging or has a congenital or acquired predisposition to hemorrhaging.
- Subject has a history of self-harm or suicidal ideation.
- Any reason that the subjects may need to be admitted to inpatient acute care in the opinion of the Investigator.
- Has any other factor which may, in the opinion of the investigator, compromise participation and/or follow-up in the study.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Cutting Edge
Circleville, Ohio, 43113
Solutions Medical Research
Coral Gables, Florida, 33134
IntraCare Clinical
Dallas, Texas, 75254
Prohealth Research Center
Doral, Florida, 33166
Betancourt Research Services
Doral, Florida, 33172
Family First Medical Research Center
Hialeah Gardens, Florida, 33016
New Dawn Wellness and Medical Center
Houston, Texas, 77082
Clinical Trials of New England
Hyde Park, Massachusetts, 02136
Symphony
Palm Harbor, Florida, 34684
Advanced Foot Care
Phoenix, Arizona, 85053
RITE Clinicals
Shenandoah, Texas, 77429
Avita Clinical Research
Tampa, Florida, 33613
AFC - Tucson
Tucson, Arizona, 85718
About this study
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
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.
Read the detailed description
A total of 40 subjects (25 in the treatment group and 15 in the control group) will be randomized to receive either NOX1416 plus SOC or SOC alone. NOX1416 is a foam based gaseous nitric oxide (NO) product where NO is delivered topically through a microbubble foam. One pump each of Solution A (0.3g, containing citric acid) and Solution B (0.3g, containing Sodium nitrite) will be dispensed and mixed upon depression of the wye nozzle dispenser, and then applied immediately per each square centimeter of wound area using any sterile applicator. NOX1416 is topically applied directly onto the wound bed and left on the wound bed for a 5-minute period then rinsed off or wiped off with a wet, sterile cloth.
Subjects randomized to the NOX1416 treatment group will receive once a day application, for a total of 12 weeks with a double treatment, 10 minutes apart, on the first day. Subjects randomized to the control group will receive standard of care, alone. Standard of care will include evaluation to document, offloading, adequate arterial flow, wound cleansing, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of a moist wound environment, and management of infection.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- NOX1416 and SOC, SOC (Standard of care)
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOX1416 and SOCDrug
Also called ADVANOX
Topical Nitric Oxide
SOC (Standard of care)Procedure or surgery
SOC as provided in the Arm/Group description.
| Study group | Role | What they receive |
|---|---|---|
| NOX1416 and SOC | Experimental | NOX1416 is a foam based gaseous nitric oxide (NO) product that will be topically applied directly onto the wound bed and left on the wound bed for a 5-minute period. Subjects randomized to the NOX1416 treatment group will receive once a day application, for a total of 12 weeks with a double treatment, 10 minutes apart, on the first day.
Standard of care will include evaluation to document, offloading, adequate arterial flow, wound cleansing, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of a moist wound environment, and management of infection. Receives: Drug: NOX1416 and SOC |
| SOC (Standard of care) | Active comparator | Subjects randomized to the control group will receive standard of care, alone. Standard of care will include evaluation to document, offloading, adequate arterial flow, wound cleansing, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of a moist wound environment, and management of infection. Receives: Procedure: SOC (Standard of care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with a Methemoglobin >5% at any assessment point
Methemoglobin is measured using co-oximetry
Measured: 14 weeks
Incidence and severity of treatment-emergent adverse events (TEAEs)
Incidence and severity of treatment-emergent adverse events (TEAEs), including serious adverse events and adverse events resulting in permanent discontinuation of protocol-defined therapy
Measured: 16 weeks
Secondary outcomes (6)
Proportion of subjects with complete wound closure during the 12 weeks of the Treatment Phase
Complete wound closure is defined as 100% re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart. Complete wound closure will be evaluated by the blinded evaluator.
Measured: 12 weeks
Wound Area Change (%) during the 12 weeks of the Treatment Phase
Wound area change is defined as the percentage of wound area change as measured by Swift Imaging device.
Measured: 12 weeks
Wound volume change (%) during the 12 weeks of the Treatment Phase
Wound volume change is defined as the percentage of change based on manual measurements of L x W x D in centimeters.
Measured: 12 weeks
Time to complete wound closure during the 12 weeks of the Treatment Phase
Complete wound closure is defined as 100% re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart. Complete wound closure will be evaluated by the blinded evaluator.
Measured: 12 weeks
Proportion of subjects who do not develop an infection during the 12 weeks of the Treatment Phase
Based on the clinical signs of infection per PI clinical judgement
Measured: 12 weeks
Changes in Wound-Q Health-Related Quality of Life (Life Impact Psychological, Social) scores during the 12 weeks of the Treatment Phase
Life Impact (8 item), Psychological (10 item), and Social (5 item) scales will be used to assess the impact of wound healing on the subject's Quality of Life. There is no overall or total WOUND-Q score. The WOUND-Q is composed of independently functioning scales that are scored separately. To score a scale, the raw scores for the set of items in a scale are added together to produce a total raw score. If missing data is less than 50% of the scale's items, the within person mean for the completed items can be imputed for the missing items prior to computing a total raw score. Once a total raw score for the scale is computed, the Conversion Table can be used to convert the raw score into a score that ranges from 0 (worst) to 100 (best). Higher scores for WOUND-Q scales reflect a better outcome.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start6 Jun 2024
- Primary completion14 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 40 subjects (25 in the treatment group and 15 in the control group) will be randomized to receive either NOX1416 + SOC or SOC alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NOxy Health Products, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402565
- Sponsor's protocol ID
- NO-003
- Acronym
- NTCDU
- Status last verified
- May 2026
- First submitted
- 23 Apr 2024
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06402565
- Acronym / sponsor ID
- NTCDU / NO-003
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NOxy Health Products, LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 14 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A total of 40 subjects (25 in the treatment group and 15 in the control group) will be randomized to receive either NOX1416 plus SOC or SOC alone. NOX1416 is a foam based gaseous nitric oxide (NO) product where NO is delivered topically through a microbubble foam. One pump each of Solution A (0.3g, containing citric acid) and Solution B (0.3g, containing Sodium nitrite) will be dispensed and mixed upon depression of the wye nozzle dispenser, and then applied immediately per each square centimeter of wound area using any sterile applicator. NOX1416 is topically applied directly onto the wound bed and left on the wound bed for a 5-minute period then rinsed off or wiped off with a wet, sterile cloth.
Subjects randomized to the NOX1416 treatment group will receive once a day application, for a total of 12 weeks with a double treatment, 10 minutes apart, on the first day. Subjects randomized to the control group will receive standard of care, alone. Standard of care will include evaluation to document, offloading, adequate arterial flow, wound cleansing, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of a moist wound environment, and management of infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 40 subjects (25 in the treatment group and 15 in the control group) will be randomized to receive either NOX1416 + SOC or SOC alone.
| Arm | Type | Receives |
|---|---|---|
| NOX1416 and SOC | Experimental | Drug: NOX1416 and SOCNOX1416 is a foam based gaseous nitric oxide (NO) product that will be topically applied directly onto the wound bed and left on the wound bed for a 5-minute period. Subjects randomized to the NOX1416 treatment group will receive once a day application, for a total of 12 weeks with a double treatment, 10 minutes apart, on the first day. Standard of care will include evaluation to document, offloading, adequate arterial flow, wound cleansing, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of a moist wound environment, and management of infection. |
| SOC (Standard of care) | Active comparator | Procedure: SOC (Standard of care)Subjects randomized to the control group will receive standard of care, alone. Standard of care will include evaluation to document, offloading, adequate arterial flow, wound cleansing, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of a moist wound environment, and management of infection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Subjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening:
- Male or female subjects aged 18 to 80 years (inclusive) with Type 1 or Type 2 diabetes requiring treatment with oral medications and/or insulin replacement therapy
- Subject has a glycosylated hemoglobin, HbA1c ≤ 12%. Note: Prior documented HbA1c within the last 3 months of the Screening Visit is acceptable.
- Presence of at least one diabetic foot ulcer that meets all of the following criteria:
- Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg or an ABI between 0.7 and ≤ 1.3, or TBI of >0.6 within 3 months of the first Screening Visit. The assessment may also be performed between SV1 and SV2.
Key exclusion criteria (37 listed)
- Subjects meeting ANY of the following criteria at time of Screening will be excluded from enrollment:
- Ulcers with exposed bone or associated with osteomyelitis. Note: Osteomyelitis should be ruled out by clinical examination (probing of the wound) or X-ray findings, if necessary, by the Investigator.
- Subject has ulcers secondary to a disease other than diabetes, e.g., fungal ulcerations, malignant ulcerations, and ulcerations due to venous or arterial insufficiency, or due to hematological disorders, in the opinion of the Principal Investigator.
- Ulcer, which in the opinion of the Investigator, is suspicious for cancer.
- Subjects with a gangrenous or ischemic toe that may need to be amputated in the opinion of the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOX1416 and SOCAlso: ADVANOXTopical Nitric Oxide | Drug | NOX1416 and SOC |
| SOC (Standard of care)SOC as provided in the Arm/Group description. | Procedure or surgery | SOC (Standard of care) |
Primary outcome
Number of subjects with a Methemoglobin >5% at any assessment point
Time frame: 14 weeks
Methemoglobin is measured using co-oximetry
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: 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
6 secondary outcomes
Proportion of subjects with complete wound closure during the 12 weeks of the Treatment Phase
Time frame: 12 weeks
Wound Area Change (%) during the 12 weeks of the Treatment Phase
Time frame: 12 weeks
Wound volume change (%) during the 12 weeks of the Treatment Phase
Time frame: 12 weeks
Time to complete wound closure during the 12 weeks of the Treatment Phase
Time frame: 12 weeks
Proportion of subjects who do not develop an infection during the 12 weeks of the Treatment Phase
Time frame: 12 weeks
Changes in Wound-Q Health-Related Quality of Life (Life Impact Psychological, Social) scores during the 12 weeks of the Treatment Phase
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NOX1416 and SOC in people with Diabetic Foot Ulcer, run by NOxy Health Products, LLC at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with a Methemoglobin >5% at any assessment point (time frame: 14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.