NOX1416 for Diabetic Foot Ulcers

(NTCDU Trial)

Recruiting at 4 trial locations

Overseen By Timothy Jacobson

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: NOxy Health Products, LLC

Must be taking: Oral medications, Insulin

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: Osteomyelitis, BMI > 40, Sepsis, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently receiving or scheduled to receive immunosuppressants, certain cancer treatments, or have had recent lower limb surgery. It's best to discuss your specific medications with the trial team.

Is NOX1416 safe for treating diabetic foot ulcers?

The treatment, known as EDX110 in a study, was well tolerated with no significant difference in adverse events compared to standard care. There were fewer serious adverse events related to the ulcer in the EDX110 group, suggesting it is generally safe for use in humans. ^{1 2 3 4 5}

How does NOX1416 treatment for diabetic foot ulcers differ from other treatments?

NOX1416 is unique because it generates nitric oxide, which helps improve blood flow and promotes healing in diabetic foot ulcers. This is different from other treatments like TLC-NOSF dressings or resorbable glass fiber matrices, which use different mechanisms to aid healing. ^{1 4 6 7 8}

What is the purpose of this trial?

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.

Research Team

Thomas Serena, MD

Principal Investigator

SerenaGroup, Inc.

Eligibility Criteria

This trial is for individuals with chronic, non-healing diabetic foot ulcers. Participants should be adults who have had a foot ulcer for an extended period without improvement. They must be able to receive standard care treatments alongside the trial medication or placebo.

Inclusion Criteria

Subject does not smoke or use tobacco products

My last HbA1c level was 12% or lower within the last 3 months.

I am willing and able to follow the study's procedures and dressing changes.

Exclusion Criteria

Any other factor compromising participation and/or follow-up in the study

I am prone to bleeding easily.

Methemoglobin > 5% at Screening Visit

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NOX1416 or standard of care for diabetic foot ulcers

12 weeks

Daily application for 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• NOX1416

Trial Overview The study tests NOX1416's safety and effectiveness in healing diabetic foot ulcers compared to a placebo, both used with standard wound care. Patients are randomly chosen to get either NOX1416 or a fake drug (placebo) without knowing which one they're getting.

Participant Groups

Group I: NOX1416 and SOC Experimental Treatment 1 Intervention

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.

Group II: SOC (Standard of care) Active Control 1 Intervention

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 Is Running the Clinical Trial?

NOxy Health Products, LLC

Lead Sponsor

Trials

2

Recruited

70+

SerenaGroup, Inc.

Collaborator

Trials

32

Recruited

3,900+

Findings from Research

In a Phase 2 clinical trial involving 172 patients with diabetic foot ulcers, the topical treatment NorLeu(3)-A(1-7) (DSC127) demonstrated significant efficacy, with 80% of ulcers treated with the 0.03% concentration completely healing by Week 12, compared to only 40% in the placebo group.

DSC127 was found to be safe, with no significant adverse events reported, and it accelerated healing time, reducing the median healing duration from 22 weeks in the placebo group to just 8.5 weeks for the 0.03% DSC127 group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NorLeu3-A(1-7) stimulation of diabetic foot ulcer healing: results of a randomized, parallel-group, double-blind, placebo-controlled phase 2 clinical trial. Balingit, PP., Armstrong, DG., Reyzelman, AM., et al.[2021]

In a phase 3 study involving 289 patients with diabetic foot ulcers, the topical solution of Diperoxochloric acid (DPOCL) led to a significantly higher rate of complete wound closure (76%) compared to isotonic sodium chloride solution (ISCL) (62%) after 10 weeks.

DPOCL also resulted in a significantly smaller mean wound surface area (0.639 cm²) compared to ISCL (0.818 cm²), indicating its efficacy in promoting healing without major safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Topical Solution of Diperoxochloric Acid for Neuropathic Diabetic Foot Ulcer: Results from a Phase 3, Multicentre, Randomized, Active-controlled, Parallel-group Study. Bal, A., Jain, SK., Jagannath, ., et al.[2022]

The incidence of diabetic foot ulcers (DFU) is rising globally, making effective treatment crucial to prevent infections and amputations.

The TLC-NOSF dressing, which combines lipidocolloid technology with nano-oligosaccharide factors, has shown effectiveness in managing DFU, supporting its use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uso de apósitos con TLC-NOSF en el manejo de la úlcera de pie diabético, basado en la revisión de la evidencia y la práctica clínica. Sagüez, FS., Gallardo, RC., Pozo, AP.[2021]

In a randomized controlled trial involving 40 participants, the resorbable glass microfiber matrix (BBGFM) significantly improved healing rates of diabetic foot ulcers (DFUs) at 12 weeks, with 70% of wounds healed compared to only 25% in the standard of care group.

The BBGFM group also showed a greater reduction in wound area (79% vs. 37%) and improved neuropathic scores, indicating better overall outcomes without any adverse events related to the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-centre, single-blinded randomised controlled clinical trial evaluating the effect of resorbable glass fibre matrix in the treatment of diabetic foot ulcers. Armstrong, DG., Orgill, DP., Galiano, RD., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Multicenter, randomized controlled, observer-blinded study of a nitric oxide generating treatment in foot ulcers of patients with diabetes-ProNOx1 study. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

NorLeu3-A(1-7) stimulation of diabetic foot ulcer healing: results of a randomized, parallel-group, double-blind, placebo-controlled phase 2 clinical trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Topical Solution of Diperoxochloric Acid for Neuropathic Diabetic Foot Ulcer: Results from a Phase 3, Multicentre, Randomized, Active-controlled, Parallel-group Study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Management of diabetic foot ulcers with a TLC-NOSF wound dressing. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Topical Recombinant Human Epidermal Growth Factor for Diabetic Foot Ulcers: A Meta-Analysis of Randomized Controlled Clinical Trials. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Uso de apósitos con TLC-NOSF en el manejo de la úlcera de pie diabético, basado en la revisión de la evidencia y la práctica clínica. [2021]

7. England pubmed.ncbi.nlm.nih.gov

A multi-centre, single-blinded randomised controlled clinical trial evaluating the effect of resorbable glass fibre matrix in the treatment of diabetic foot ulcers. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Overcoming Barriers to Wound Healing in a Neuropathic and Neuro-Ischaemic Diabetic Foot Cohort Using a Novel Bilayer Biodegradable Synthetic Matrix. [2023]