NO Sensor to Record Wound Data in Acute or Chronic Wounds

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

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.

Study Overview

• Status: Completed
• Conditions: Volumetric Muscle Loss
• Intervention / Treatment: Device: NO Sensor

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • UPMC Mercy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NO Sensor; NO sensor placed into wound bed	Device: NO Sensor; NO sensor measuring wound characteristic data in wound bed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants meet all inclusion/exclusion criteria - a minimum of 5 participants have completed Inclusion/Exclusion in CRF-01		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		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		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		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	A follow up phone call within 72 hours and an in-person clinic visit within 2-8 weeks of NO Sensor application	up to 8 weeks

Collaborators and Investigators

• Sponsor: Stephen Badylak
• Collaborators: Defense Advanced Research Projects Agency
• Investigators: Principal Investigator: Stephen Badylak, MD,DVM,PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2025
• Primary Completion (Actual): October 28, 2025
• Study Completion (Actual): October 28, 2025

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 28, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STUDY25010133; D20AC00002-13 (Other Grant/Funding Number: DARPA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan to raw share data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No