Nitric Oxide Sensor for Wound Healing

Overseen By Gayle Gordillo, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stephen Badylak

Disqualifiers: Chemotherapy, Pregnancy, Immunosuppression, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new sensor that measures nitric oxide levels in wounds to determine if it can track healing progress. Different healing stages might be indicated by high or low nitric oxide levels. The trial involves placing the sensor in the wound for 30-60 minutes and includes two follow-up appointments to monitor progress. Suitable participants have injuries on their arms or legs with a wound size of 2-10 cm that can accommodate the sensor.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance wound healing monitoring.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on chemotherapy or immunosuppressive therapy, you would not be eligible to participate.

What prior data suggests that this NO Sensor is safe for wound measurement?

Research has shown that using a Nitric Oxide (NO) Sensor is generally safe. Studies suggest that NO aids wound healing by preventing infections and reducing swelling when used correctly. The NO Sensor measures the amount of NO in a wound without altering or adding anything to the body. No reports of harmful effects have emerged, indicating it is well-tolerated. For any concerns, consulting a doctor is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The NO Sensor is unique because it offers a new way to monitor and potentially enhance wound healing by measuring nitric oxide levels directly in the wound bed. Unlike traditional treatments like dressings and topical ointments, which focus on protecting and moisturizing the wound, this sensor provides real-time data on the wound's healing progress. Researchers are excited about this technology because it could lead to more personalized and effective treatment plans by giving healthcare providers detailed insights into the wound's condition and healing trajectory.

What evidence suggests that this NO Sensor is effective for wound healing?

Research has shown that nitric oxide (NO) plays a key role in healing wounds. Cells in the wound produce NO, which helps manage inflammation, a normal part of healing. Studies have found that checking NO levels provides useful insights into wound healing progress. In this trial, the NO Sensor monitors these levels in real-time, potentially aiding doctors in understanding wound care. Early results suggest that tracking NO can improve wound management by indicating how the body responds to treatment. ^{1 2 4 6 7}

Who Is on the Research Team?

Stephen Badylak, MD,DVM,PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for individuals with acute or chronic wounds, potentially related to muscle atrophy. Participants will have a Nitric Oxide (NO) Sensor placed in their wound to record healing data. Specific eligibility criteria are not provided, but typically include general health requirements and consent.

Inclusion Criteria

Wound amenable to NO Sensor placement

I have an injury to my arm or leg.

My wound is between 2-10 cm wide.

Exclusion Criteria

I am currently experiencing bleeding in a wound.

Physician discretion for patients with complex medical conditions or high mortality risks

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

NO Sensor Application

The NO Sensor is placed into the participant's wound to collect NO measurements for 30-60 minutes

1 day

1 visit (in-person)

Follow-up

Participants have follow-up appointments to assess wound healing over time

up to 8 weeks

1 phone call, 1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NO Sensor

Trial Overview The NO Sensor is being tested for its ability to measure the levels of Nitric Oxide in wounds, which may indicate the stage of healing. The study involves placing the sensor in the wound for up to an hour and monitoring healing over time through follow-up appointments.

How Is the Trial Designed?

Group I: NO Sensor Experimental Treatment 1 Intervention

NO sensor placed into wound bed

Who Is Running the Clinical Trial?

Stephen Badylak

Lead Sponsor

Defense Advanced Research Projects Agency

Collaborator

Trials

19

Recruited

78,900+

Citations

1. science.org science.org/doi/10.1126/sciadv.adv2385

Wound state monitoring by multiplexed, electrochemical ... MERLIN allows spatial mapping of the NO gradient across the wound bed, which can be used to provide diagnostic information to assist wound care.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12118596/

Wound state monitoring by multiplexed, electrochemical, ... Nitric oxide (NO) released endogenously by induced NO synthase (iNOS) in macrophages is a key regulatory biomarker for wound inflammation.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0753332222000956

Nitric oxide-releasing biomaterials for promoting wound ... In this article, we review the etiology of diabetic wounds, wound healing strategies, and the role of NO in the wound healing process.

4. withpower.com withpower.com/trial/phase-volumetric-muscle-loss-4-2025-e77c0

Nitric Oxide Sensor for Wound Healing The purpose of this research is to evaluate the ability of a Nitric Oxide (NO) Sensor to collect NO measurement data from an open wound.

5. biorxiv.org biorxiv.org/content/10.1101/2024.11.12.623289v1.full.pdf

Wound state monitoring by multiplexed, electrochemical, ... Here we present a compliant, multiplexed, electrochemical, real-time, localized, inflammation-tracking nitric oxide sensor (MERLIN) array for in ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0002944012000156

Nitric Oxide–Releasing Nanoparticles Accelerate Wound ... We found that topical application of NO-np can reduce the duration for wound resolution by regulating the interaction of fibroblasts, inflammatory cells, ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/93/NCT04123093/Prot_SAP_000.pdf

Safety and Efficacy of the Noxsano Wound Care Bandage: ... As mentioned, NO is involved in the wound healing process at all stages and its mechanism of action is not yet completely understood. The ...