Burn WoundGE-MTECNCT05796492
Ultrasound Treatment on Wound Healing Time
A study testing Pulsed splenic ultrasound and Ultrasound probe (no energy applied) in people with Burn Wound and 2nd Degree Burn of the Skin, run by General Electric Research at 1 site in United States.
Trial summary
This is a randomized, sham-controlled pilot study that will assess the safety and feasibility of splenic focused pulsed ultrasound treatment on burn wound healing time in 24 subjects (12 active ultrasound and 12 sham controls). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burn Wound, 2nd Degree Burn of the Skin
- What is being tested?
- Pulsed splenic ultrasound and Ultrasound probe (no energy applied)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2023to 19 Dec 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female aged 18 or older
- Second-degree burn wounds of less than 20% total body surface area (TBSA)
- No active wound infection at screening based on clinical criteria
- Able to provide written informed consent
Who cannot join
- Wounds determined by study clinicians to be ineligible, including those that may inhibit access to the spleen for the ultrasound procedure
- Participating in another research study that may affect the conduct of results of this study
- BMI > 30
- Having or exhibiting any of the following:
- Previous surgery of the spleen, esophagus, stomach, duodenum, or liver, including splenectomy
- End stage renal disease and/or uremia
Show all 27Show fewer
- Active malignancy
- Previous leukemia and/or lymphoma
- Human immunodeficiency virus infection or AIDS
- Rheumatoid arthritis or other immune-mediated diseases (e.g., inflammatory bowel disease
- Arrythmias, including but not limited to, atrial fibrillation, atrial flutter, clinically significant bradycardia, ventricular arrhythmias, and A-V block
- Implanted pacemaker or cardioverter/debribrillator
- History of unstable angina, angioplasty or coronary arterial by-pass grafting surgery
- History of stroke or TIA
- Untreated thrombosis or bleeding disorders
- Currently implanted vagus nerve stimulator
- Currently implanted spinal cord stimulator or other chronically implanted electronic device
- Receiving oral, topical, rectal, or parenteral corticosteroids in an unstable dose 4 weeks prior to baseline visit
- Any immunosuppressive or cytotoxic medications
- Clinically relevant history of alcohol or drug abuse as determined by the investigator including:
- alcohol consumption within 4 days of the baseline visit
- tobacco or nicotine product use within the past 1 month
- recreational drug use within the past 1 month
- Pregnant or breast feeding
- Unable or unwilling to comply with study procedures
- Have recently (within 3 months) been diagnosed with COVID, or have ever been diagnosed with long COVID
- Have an autoimmune disorder, such as, rheumatoid arthritis or lupus
Trial locations and contacts
1 site in 1 country.
United States1 site
LAC+USC Medical Center
Los Angeles, California, 90033
About this study
Official title: Fieldable Ultrasound Treatment to Enhance Inflammatory-Proliferative Phase Transition and Reduce Wound Healing Time
This is a randomized, sham-controlled pilot study that will assess the safety and feasibility of splenic focused pulsed ultrasound treatment on burn wound healing time in 24 subjects (12 active ultrasound and 12 sham controls).
Read the detailed description
The Central Hypothesis underlying this study is that splenic ultrasound stimulation activates the splenic anti-inflammatory pathway, thereby producing reduction in circulating macrophage cytokine production, reduction of neutrophil invasiveness, or induction of phenotypic transition in circulating immune cells (e.g., M1 to M2 transition in macrophages) in patients with partial thickness wounds that cover <20% body surface area.
Approximately 24 subjects will participate in this study. Male and female subjects of all races and ethnicities will be recruited for study from the ethnically diverse patient population of the LAC+USC Burn Center from the surrounding area.
Phase 0
Burn wound subjects will be screened and enrolled at the LAC+USC Burn Center located in Los Angeles, California. No other sites, neither regional nor outside of the United States are going to participate in enrollment of subjects.
A General Electric LOGIQ E10 ultrasound machine with a C1-6-XD clear probe, will be used to selectively deliver pulsed ultrasound to the spleen.
12 months.
28 days or until healed (whichever comes first)
- Conditions
- Burn Wound, 2nd Degree Burn of the Skin
- Being tested
- Pulsed splenic ultrasound, Ultrasound probe (no energy applied)
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed splenic ultrasoundDevice
Also called Active ultrasound
A General Electric LOGIQ E10 ultrasound machine with a C1-6-XD clear probe, will be used to selectively deliver pulsed ultrasound to the spleen.
Ultrasound probe (no energy applied)Device
A General Electric LOGIQ E10 ultrasound probe will be placed over the spleen with no energy applied
| Study group | Role | What they receive |
|---|---|---|
| LOGIQ E10 Sham | Sham comparator | The sham condition will consist of the ultrasound probe placed over the spleen with no energy applied. Receives: Device: Ultrasound probe (no energy applied) |
| LOGIQ E10 ultrasound Active | Active comparator | The intervention condition will receive 10 minutes of splenic ultrasound daily. Receives: Device: Pulsed splenic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse device effects (ADEs)
Review of anticipated device effects after splenic ultrasound insonification in subjects with partial thickness wounds that cover <20% body surface area.
Measured: Days 1 -28
Median time to re-epithelialization using advanced digital imaging
Re-epithelialization measured by digital planimetry
Measured: 28 days or until healed (whichever comes first)
Secondary outcomes (7)
Difference in groups in pain measured visual analog scale, (VAS)
Pain, scale 0-10 with 10 being worst outcome
Measured: Days 7, 14, 21 and 28
Difference in groups in itch measured visual analog scale, (VAS)
Itch, scale 0-10 with 10 being worst outcome
Measured: Days 7, 14, 21 and 28
Difference in groups in non-invasive perfusion measured visual analog scale, (VAS)
Doppler perfusion, scale 0-10 with 10 being worst outcome
Measured: Days 7, 14, 21 and 28
Referral to scar management specialist
Scar management
Measured: Days 7, 14, 21 and 28
Scar assessments using Patient and Observer Scar Assessment Scale (POSAS)
A 5 point score ranging from 1 (normal pigmentation, no itching) to 5 (worst imaginable scar or sensation).
Measured: Days 7, 14, 21 and 28
Multiplexed analysis of plasma levels of inflammatory cytokines
Plasma levels of inflammatory cytokines, lab range values
Measured: Days 7, 14, 21 and 28
Flow cytometry analysis of phenotype of macrophage, neutrophil, and T lymphocyte populations
Phenotype of macrophage, neutrophil, and T lymphocyte, lab range values
Measured: Days 7, 14, 21 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start22 Jun 2023
- Primary completion18 Dec 2024
- Study completion19 Dec 2024
Why it stopped: recruitment/ enrollment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn WoundStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Electric Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Armstrong, DPM, MD, PhD, Principal investigator, USC Limb Preservation Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796492
- Sponsor's protocol ID
- HS-22-00019
- Acronym
- GE-MTEC
- Status last verified
- Jan 2025
- First submitted
- 22 Aug 2022
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fieldable Ultrasound Treatment to Enhance Inflammatory-Proliferative Phase Transition and Reduce Wound Healing Time
- ClinicalTrials.gov ID
- NCT05796492
- Acronym / sponsor ID
- GE-MTEC / HS-22-00019
- Conditions
- Burn Wound, 2nd Degree Burn of the Skin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment/ enrollment issues
- Enrolment
- 8 participants (actual)
- Lead sponsor
- General Electric ResearchIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 3 Apr 2023 (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.
This is a randomized, sham-controlled pilot study that will assess the safety and feasibility of splenic focused pulsed ultrasound treatment on burn wound healing time in 24 subjects (12 active ultrasound and 12 sham controls).
Detailed description
The Central Hypothesis underlying this study is that splenic ultrasound stimulation activates the splenic anti-inflammatory pathway, thereby producing reduction in circulating macrophage cytokine production, reduction of neutrophil invasiveness, or induction of phenotypic transition in circulating immune cells (e.g., M1 to M2 transition in macrophages) in patients with partial thickness wounds that cover <20% body surface area.
Approximately 24 subjects will participate in this study. Male and female subjects of all races and ethnicities will be recruited for study from the ethnically diverse patient population of the LAC+USC Burn Center from the surrounding area.
Phase 0
Burn wound subjects will be screened and enrolled at the LAC+USC Burn Center located in Los Angeles, California. No other sites, neither regional nor outside of the United States are going to participate in enrollment of subjects.
A General Electric LOGIQ E10 ultrasound machine with a C1-6-XD clear probe, will be used to selectively deliver pulsed ultrasound to the spleen.
12 months.
28 days or until healed (whichever comes first)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LOGIQ E10 Sham | Sham comparator | Device: Ultrasound probe (no energy applied)The sham condition will consist of the ultrasound probe placed over the spleen with no energy applied. |
| LOGIQ E10 ultrasound Active | Active comparator | Device: Pulsed splenic ultrasoundThe intervention condition will receive 10 minutes of splenic ultrasound daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Female aged 18 or older
- Second-degree burn wounds of less than 20% total body surface area (TBSA)
- No active wound infection at screening based on clinical criteria
- Able to provide written informed consent
Key exclusion criteria (27 listed)
- Wounds determined by study clinicians to be ineligible, including those that may inhibit access to the spleen for the ultrasound procedure
- Participating in another research study that may affect the conduct of results of this study
- BMI > 30
- Having or exhibiting any of the following:
- Receiving oral, topical, rectal, or parenteral corticosteroids in an unstable dose 4 weeks prior to baseline visit
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 |
|---|---|---|
| Pulsed splenic ultrasoundAlso: Active ultrasoundA General Electric LOGIQ E10 ultrasound machine with a C1-6-XD clear probe, will be used to selectively deliver pulsed ultrasound to the spleen. | Device | LOGIQ E10 ultrasound Active |
| Ultrasound probe (no energy applied)A General Electric LOGIQ E10 ultrasound probe will be placed over the spleen with no energy applied | Device | LOGIQ E10 Sham |
Primary outcome
Incidence and severity of adverse device effects (ADEs)
Time frame: Days 1 -28
Review of anticipated device effects after splenic ultrasound insonification in subjects with partial thickness wounds that cover <20% body surface area.
Median time to re-epithelialization using advanced digital imaging
Time frame: 28 days or until healed (whichever comes first)
Re-epithelialization measured by digital planimetry
7 secondary outcomes
Difference in groups in pain measured visual analog scale, (VAS)
Time frame: Days 7, 14, 21 and 28
Difference in groups in itch measured visual analog scale, (VAS)
Time frame: Days 7, 14, 21 and 28
Difference in groups in non-invasive perfusion measured visual analog scale, (VAS)
Time frame: Days 7, 14, 21 and 28
Referral to scar management specialist
Time frame: Days 7, 14, 21 and 28
Scar assessments using Patient and Observer Scar Assessment Scale (POSAS)
Time frame: Days 7, 14, 21 and 28
Multiplexed analysis of plasma levels of inflammatory cytokines
Time frame: Days 7, 14, 21 and 28
Flow cytometry analysis of phenotype of macrophage, neutrophil, and T lymphocyte populations
Time frame: Days 7, 14, 21 and 28
Results and safety
The study was stopped early (reason given: recruitment/ enrollment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
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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.
David Armstrong, DPM, MD, PhD principal investigator
USC Limb Preservation Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed splenic ultrasound and Ultrasound probe (no energy applied) in people with Burn Wound and 2nd Degree Burn of the Skin, run by General Electric Research 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 4 inclusion and 27 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: stopped early, as of the sponsor's last update on 17 Jan 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: recruitment/ enrollment issues). Results are not available in the source record.
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?
Incidence and severity of adverse device effects (ADEs) (time frame: Days 1 -28). The study lists 2 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 17 Jan 2025.