NO Sensor to Record Wound Data in Acute or Chronic Wounds

Completed · Not applicable

Conditions studied: Volumetric Muscle Loss

In brief

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.

Key facts

Study ID

NCT06944899

Run by

Stephen Badylak

People needed

10

Starts

2025-05-20

Expected to finish

2025-10-28

Last updated by the study team

2025-10-30

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Extremity injury
• Wound surface area 2-10 cm in diameter
• Wound amenable to NO Sensor placement
• Age at the time of consent ≥ 22 to ≤ 65 years
• Cognitively able to undergo informed consent discussion and understand the study

You may not qualify if…

• Chemotherapy
• Pregnancy
• Preexisting immunosuppressive conditions or immunosuppression therapy
• Active hemorrhage in the wound bed
• Physician discretion for patients with complex medical conditions or high mortality risks
• Patients with an active implanted device, such as a pacemaker, defibrillator, or hypoglossal or vagal nerve stimulator
• Patients requiring a legally authorized representative (LAR) for informed consent

Where it is running

• UPMC Mercy — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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