Ultrasound Treatment on Wound Healing Time

Study Overview
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Brief Summary
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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
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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)

Official Title
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Fieldable Ultrasound Treatment to Enhance Inflammatory-Proliferative Phase Transition and Reduce Wound Healing Time

Conditions
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Burn Wound, 2nd Degree Burn of the Skin

Intervention / Treatment
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* Device: Pulsed splenic ultrasound
* Device: Ultrasound probe (no energy applied)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: LOGIQ E10 Sham<br>The sham condition will consist of the ultrasound probe placed over the spleen with no energy applied. | Device: Ultrasound probe (no energy applied)<br>* A General Electric LOGIQ E10 ultrasound probe will be placed over the spleen with no energy applied<br>|
| Active Comparator: LOGIQ E10 ultrasound Active<br>The intervention condition will receive 10 minutes of splenic ultrasound daily. | Device: Pulsed splenic ultrasound<br>* 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.<br>* Other names: Active ultrasound;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Days 1 -28 | 
| Median time to re-epithelialization using advanced digital imaging | Re-epithelialization measured by digital planimetry | 28 days or until healed (whichever comes first) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in groups in pain measured visual analog scale, (VAS) | Pain, scale 0-10 with 10 being worst outcome | 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 | 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 | Days 7, 14, 21 and 28 | 
| Referral to scar management specialist | Scar management | 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). | Days 7, 14, 21 and 28 | 
| Multiplexed analysis of plasma levels of inflammatory cytokines | Plasma levels of inflammatory cytokines, lab range values | 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 | Days 7, 14, 21 and 28 |