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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05796492
Other study ID # HS-22-00019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 22, 2023
Est. completion date September 1, 2024

Study information

Verified date May 2023
Source General Electric Research
Contact Fabiola Guadalupe Rodriguez
Phone (323) 516-2132
Email fabiola.rodriguez@med.usc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date September 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Pulsed splenic 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)
A General Electric LOGIQ E10 ultrasound probe will be placed over the spleen with no energy applied

Locations

Country Name City State
United States LAC+USC Medical Center Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
General Electric Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Median time to re-epithelialization using advanced digital imaging Re-epithelialization measured by digital planimetry 28 days or until healed (whichever comes first)
Secondary 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
Secondary 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
Secondary 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
Secondary Referral to scar management specialist Scar management Days 7, 14, 21 and 28
Secondary 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
Secondary Multiplexed analysis of plasma levels of inflammatory cytokines Plasma levels of inflammatory cytokines, lab range values Days 7, 14, 21 and 28
Secondary 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
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