Completed

NCT Number: NCT06944899

NO Sensor to Record Wound Data in Acute or Chronic Wounds

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.

Completed

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Key information

Conditions

Volumetric Muscle Loss

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Mercy

Pittsburgh, Pennsylvania, 15219, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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

Treatment and study plan

NO Sensor

Device

NO sensor measuring wound characteristic data in wound bed

Primary outcomes

Participants meet all inclusion/exclusion criteria - a minimum of 5 participants have completed Inclusion/Exclusion in CRF-01

Time frame: up to 8 weeks
All wound characteristics documented - a minimum of 5 wounds assessed by Bates-Jensen Wound Assessment Tool. And documented in CRF-03

Time frame: Day 0
NO Sensor application time > 30 minutes and < 60 minutes - a minimum of 5 wounds have NO sensor applied between 30-60 minutes and documented in CRF-04

Time frame: 60 minutes
NO Sensor applied and removed according to study specific SOPs - a minimum of 5 wounds have NO Sensor applied and removed according to study specific SOPs and documented in CRF-04

Time frame: Day 0
Assessment of wound healing during participant follow-up activities - a minimum of 5 participants have follow up wound assessments according to visit schedule and documented in CRF-05 and CRF-06

Time frame: up to 8 weeks

A follow up phone call within 72 hours and an in-person clinic visit within 2-8 weeks of NO Sensor application

Sponsors and collaborators

Lead sponsor

Stephen Badylak

Other

Collaborators

Defense Advanced Research Projects Agency

Registry information

Official study title

A Single-Center Pilot Study to Test the Effectiveness of the REPAIR Nitric Oxide (NO) Sensor to Record Wound Characteristic Data

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Apr 25, 2025
Registry last updated: Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.