NO Sensor to Record Wound Data in Acute or Chronic Wounds

Launched by STEPHEN BADYLAK · Apr 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a special device called a Nitric Oxide (NO) Sensor, which is designed to measure levels of nitric oxide in wounds. Researchers believe that the amount of nitric oxide can help determine how well a wound is healing. During the study, the NO Sensor will be placed directly into the wound for about 30 to 60 minutes to collect data. After this, participants will have two follow-up appointments to monitor how their wound heals over time.

To be eligible for this trial, participants must have an injury to an arm or leg with a wound that is between 2 to 10 centimeters wide. They should be between the ages of 22 and 65 and able to understand the study and give their consent. However, certain factors, such as being pregnant, undergoing chemotherapy, or having specific medical conditions, may exclude individuals from participating. This trial is not yet recruiting, so there will be more information available as it begins.

Gender

ALL

Eligibility 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