Using a sensor to measure nitric oxide levels in wounds
A Single-Center Pilot Study to Test the Effectiveness of the REPAIR Nitric Oxide (NO) Sensor to Record Wound Characteristic Data
This study is testing a new sensor to see if measuring nitric oxide levels in open wounds can help people with extremity injuries understand how well their wounds are healing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 22 Years to 65 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06944899 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effectiveness of a Nitric Oxide (NO) Sensor in measuring nitric oxide levels in open wounds, which may indicate the healing stage of the wound. Participants with extremity injuries will have the NO Sensor placed in their wounds for 30-60 minutes to collect data. Following the initial measurement, participants will attend two follow-up appointments to monitor wound healing over time. The study aims to determine if NO levels can provide valuable insights into the healing process.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 to 65 with extremity injuries and wounds suitable for sensor placement.
Not a fit: Patients undergoing chemotherapy, those who are pregnant, or individuals with complex medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved monitoring and treatment strategies for wound healing.
How similar studies have performed: While the use of nitric oxide sensors in wound healing is a novel approach, previous studies have suggested potential benefits in monitoring wound healing.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Extremity injury 2. Wound surface area 2-10 cm in diameter 3. Wound amenable to NO Sensor placement 4. Age at the time of consent ≥ 22 to ≤ 65 years 5. Cognitively able to undergo informed consent discussion and understand the study Exclusion Criteria: 1. Chemotherapy 2. Pregnancy 3. Preexisting immunosuppressive conditions or immunosuppression therapy 4. Active hemorrhage in the wound bed 5. Physician discretion for patients with complex medical conditions or high mortality risks 6. Patients with an active implanted device, such as a pacemaker, defibrillator, or hypoglossal or vagal nerve stimulator 7. Patients requiring a legally authorized representative (LAR) for informed consent
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Mercy — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Stephen Badylak, MD,DVM,PhD — University of Pittsburgh
- Study coordinator: Gayle Gordillo, MD
- Email: gordillogm@upmc.edu
- Phone: 614-562-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.