NO Sensor to Record Wound Data in Acute or Chronic Wounds

NCT ID: NCT06944899

Last Updated: 2025-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-20

Study Completion Date

2025-10-28

Brief Summary

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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.

Detailed Description

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Conditions

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Volumetric Muscle Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

proof of concept
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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NO Sensor

NO sensor placed into wound bed

Group Type EXPERIMENTAL

NO Sensor

Intervention Type DEVICE

NO sensor measuring wound characteristic data in wound bed

Interventions

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NO Sensor

NO sensor measuring wound characteristic data in wound bed

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Defense Advanced Research Projects Agency

FED

Sponsor Role collaborator

Stephen Badylak

OTHER

Sponsor Role lead

Responsible Party

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Stephen Badylak

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Stephen Badylak, MD,DVM,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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UPMC Mercy

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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D20AC00002-13

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY25010133

Identifier Type: -

Identifier Source: org_study_id

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