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

10 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment NO Sensor for wound healing?

Research shows that nitric oxide (NO) plays a key role in wound healing by promoting blood vessel formation, reducing inflammation, and helping cells grow and repair. A study on a flexible NO-releasing patch demonstrated strong antibacterial effects and potential for treating chronic wounds, suggesting that NO-based treatments can effectively aid wound healing. ^{1 2 3 4 5}

Is the Nitric Oxide Sensor for Wound Healing safe for humans?

Research shows that nitric oxide (NO) releasing technologies, like sensors and patches, have been studied for their safety and effectiveness in wound healing and other medical applications. These studies suggest that NO can help prevent infections and reduce inflammation, making it generally safe for use in humans when applied correctly. ^{1 5 6 7 8}

How does the Nitric Oxide Sensor treatment for wound healing differ from other treatments?

The Nitric Oxide Sensor treatment is unique because it uses a flexible patch that releases nitric oxide (NO) to kill bacteria and promote wound healing. Unlike traditional treatments, this patch continuously releases NO for up to four days, providing a potentially more effective and cost-efficient option for treating chronic wounds. ^{1 6 9 10 11}

What is the purpose of this trial?

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. Previous research suggests that NO levels may indicate the stage of healing the wound is in. This study is being done to determine if the NO Sensor can measure how much NO is in a participant's wound. The researcher will place the NO Sensor into a participant's wound to collect NO measurements for 30-60 minutes. The participant will then have 2 follow-up appointments to see how the wound heals over time.

Research Team

Stephen Badylak, MD,DVM,PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

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

Electrochemically Modulated Nitric Oxide Release From Flexible Silicone Rubber Patch: Antimicrobial Activity For Potential Wound Healing Applications. [2020]

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

Nitric oxide: a newly discovered function on wound healing. [2022]

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

Nitric oxide in the healing wound: a time-course study. [2022]

4. China pubmed.ncbi.nlm.nih.gov

[Immunohistochemical study on expression of iNOS and eNOS during skin incised wound healing in mice]. [2005]

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

Nitric oxide-releasing nanoparticles accelerate wound healing by promoting fibroblast migration and collagen deposition. [2014]

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

Nitric Oxide Release for Improving Performance of Implantable Chemical Sensors - A Review. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Nitric oxide-releasing/generating polymers for the development of implantable chemical sensors with enhanced biocompatibility. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Nitric oxide release: part III. Measurement and reporting. [2022]

9. Japan pubmed.ncbi.nlm.nih.gov

Evaluation of coronary endothelial function by catheter-type NO sensor in high-fat-diet-induced obese dogs. [2019]

10. England pubmed.ncbi.nlm.nih.gov

A flexible and physically transient electrochemical sensor for real-time wireless nitric oxide monitoring. [2023]

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

Sensing Nitric Oxide in Cells: Historical Technologies and Future Outlook. [2021]