COMPLETED

NO Sensor to Record Wound Data in Acute or Chronic Wounds

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-20

Study Completion:2025-10-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06944899

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Principal Investigator

Stephen Badylak, MD,DVM,PhD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

UPMC Mercy

Pittsburgh, Pennsylvania, 15219

United States

Collaborators and Investigators

Sponsor: Stephen Badylak

Stephen Badylak, MD,DVM,PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-20

Study Completion Date2025-10-28

Study Record Updates

Study Start Date2025-05-20

Study Completion Date2025-10-28

Terms related to this study

Additional Relevant MeSH Terms

Volumetric Muscle Loss