Volumetric Muscle LossNCT06944899
NO Sensor to Record Wound Data in Acute or Chronic Wounds
A study testing NO Sensor in people with Volumetric Muscle Loss, run by Stephen Badylak at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Volumetric Muscle Loss
- What is being tested?
- NO Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2025to 28 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Volumetric Muscle Loss
- Being tested
- NO Sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO SensorDevice
NO sensor measuring wound characteristic data in wound bed
| Study group | Role | What they receive |
|---|---|---|
| NO Sensor | Experimental | NO sensor placed into wound bed Receives: Device: NO Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants meet all inclusion/exclusion criteria - a minimum of 5 participants have completed Inclusion/Exclusion in CRF-01
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start20 May 2025
- Primary completion28 Oct 2025
- Study completion28 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volumetric Muscle LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- proof of concept
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephen Badylak
- Sponsor type
- University, hospital or other
- Collaborators
- Defense Advanced Research Projects Agency
- Responsible party
- Sponsor-investigator, Stephen Badylak, University of Pittsburgh
- Investigators
- Stephen Badylak, MD,DVM,PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944899
- Sponsor's protocol ID
- STUDY25010133
- Other IDs
- D20AC00002-13
- Status last verified
- Oct 2025
- First submitted
- 4 Apr 2025
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to raw share data
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Pilot Study to Test the Effectiveness of the REPAIR Nitric Oxide (NO) Sensor to Record Wound Characteristic Data
- ClinicalTrials.gov ID
- NCT06944899
- Acronym / sponsor ID
- STUDY25010133
- Conditions
- Volumetric Muscle Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Stephen BadylakUniversity, hospital or other
- Collaborators
- Defense Advanced Research Projects Agency
- Study start
- 20 May 2025 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 28 Oct 2025 (actual)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- proof of concept
| Arm | Type | Receives |
|---|---|---|
| NO Sensor | Experimental | Device: NO SensorNO sensor placed into wound bed |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NO SensorNO sensor measuring wound characteristic data in wound bed | Device | NO Sensor |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Individual participant dataSharing planned: No. no plan to raw share data
Related trials for Volumetric Muscle Loss
Recruiting
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Traumatic Amputation of Lower Extremity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Badylak, MD,DVM,PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NO Sensor in people with Volumetric Muscle Loss, run by Stephen Badylak at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants meet all inclusion/exclusion criteria - a minimum of 5 participants have completed Inclusion/Exclusion in CRF-01 (time frame: up to 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.