NO Sensor to Record Wound Data in Acute or Chronic Wounds

NCT06944899 | Completed

• 2 other identifiers: STUDY25010133D20AC00002-13
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Volumetric Muscle Loss

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

NO Sensor

EXPERIMENTAL

NO sensor placed into wound bed

Device: NO Sensor

Interventions

NO Sensor DEVICE

NO sensor measuring wound characteristic data in wound bed

NO Sensor

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Stephen Badylak: lead
• Defense Advanced Research Projects Agency: collaborator

Study Sites (1)

UPMC Mercy

Pittsburgh, Pennsylvania, 15219, United States

Location

Study Officials

• Stephen Badylak, MD,DVM,PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: proof of concept

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 25, 2025
• Study Start: May 20, 2025
• Primary Completion: October 28, 2025
• Study Completion: October 28, 2025
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)