Status:
COMPLETED
NO Sensor to Record Wound Data in Acute or Chronic Wounds
Lead Sponsor:
Stephen Badylak
Collaborating Sponsors:
Defense Advanced Research Projects Agency
Conditions:
Volumetric Muscle Loss
Eligibility:
All Genders
22-65 years
Phase:
NA
Brief Summary
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 stag...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06944899
Start Date
May 20 2025
End Date
October 28 2025
Last Update
October 30 2025
Active Locations (1)
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1
UPMC Mercy
Pittsburgh, Pennsylvania, United States, 15219