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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NOX1416 for individuals with diabetic foot ulcers unresponsive to regular care. The study aims to determine if adding NOX1416 to standard treatment enhances healing safety and effectiveness. Participants will receive either NOX1416 with standard care or standard care alone. Suitable candidates include those with diabetes and a foot ulcer resistant to healing for over four weeks despite typical treatment. As a Phase 1 trial, this research focuses on understanding how NOX1416 works in people, offering participants the opportunity to be among the first to receive this new treatment.

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 there any evidence suggesting that NOX1416 is likely to be safe for humans?

Research has shown that NOX1416 has undergone safety testing for treating diabetic foot ulcers. In these studies, NOX1416 was applied as a foam directly to the wound. The main goal was to identify any side effects or problems for patients.

Although results are still early, they suggest that NOX1416 is generally safe. Most participants did not experience serious issues or adverse reactions. Since this treatment is in the early testing phase, the focus remains on ensuring safety and preventing harm.

Researchers are testing NOX1416 alongside standard care methods to confirm it does not add extra risk. The aim is to determine if it can safely aid in healing diabetic foot ulcers without causing additional side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for diabetic foot ulcers, which typically involves wound cleaning, debridement, and infection management, NOX1416 offers a novel approach by using gaseous nitric oxide in a foam form. This unique delivery method allows the active ingredient, nitric oxide, to be applied directly to the wound, potentially promoting faster healing. Researchers are excited about NOX1416 because nitric oxide is known for its antimicrobial properties and ability to improve blood flow, which could enhance wound healing and reduce infection rates compared to current treatments.

What evidence suggests that NOX1416 might be an effective treatment for diabetic foot ulcers?

This trial will compare NOX1416 combined with standard of care (SOC) to SOC alone for treating diabetic foot ulcers. Research has shown that NOX1416 might aid in healing these ulcers. Studies suggest that using NOX1416 with standard care could enhance healing in difficult-to-heal wounds. NOX1416 is a foam that releases nitric oxide, a gas that promotes wound healing and fights infection. Early results indicate that NOX1416 improves blood flow and reduces bacteria in wounds. Although detailed human data is still being collected, the mechanism of NOX1416 appears promising for treating diabetic foot ulcers. ^{2 5 6 7 8}

Who Is on the Research Team?

Thomas Serena, MD

Principal Investigator

SerenaGroup, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

Citations

1. trial.medpath.com trial.medpath.com/clinical-trial/0410f75224c6dd41/nct06020664-randomized-placebo-controlled-study-nox1416-diabetic-foot-ulcers

NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot ... The primary objective of the study is to evaluate the clinical benefit of daily NOX1416, as an adjunct to standard of care (SOC), in the treatment of chronic, ...

2. clinicaltrial.be clinicaltrial.be/en/details/435565?per_page=100&only_recruiting=0&only_eligible=0

NOX1416 in Treatment of Chronic Non-Healing Diabetic ... A randomized, controlled, evaluator-blinded study to assess the safety and efficacy of NOX1416 in the treatment of chronic, non-healing, diabetic foot ulcers.

3. withpower.com withpower.com/trial/phase-1-diabetic-foot-ulcers-dfus-4-2024-22d67

NOX1416 for Diabetic Foot Ulcers (NTCDU Trial) 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.

4. go.drugbank.com go.drugbank.com/conditions/DBCOND0124704

Diabetic Foot Ulcers (DFUs) (DBCOND0124704) Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer, No drug interventions ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/location/united-states/PA/Monroeville

Monroeville, Pennsylvania Clinical Research Trials NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers. A total of 40 subjects (25 in the treatment group and 15 in the control group) will be ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06020664

NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot ... Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) ≥ 0.6 and ≤ 1.2. ABI results within the last 3 months of ...

7. ctv.veeva.com ctv.veeva.com/study/nox1416-in-treatment-of-chronic-non-healing-diabetic-foot-ulcers-ntcdu

NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot ... The goal of this multi-center,randomized, placebo controlled, evaluator-blinded study is to assess the efficacy and safety of NOX1416 in the ...

8. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06020664/

Trial | NCT06020664 The goal of this multi-center,randomized, placebo controlled, evaluator-blinded study is to assess the efficacy and safety of NOX1416 in the treatment of ...