Ultrasound Treatment on Wound Healing Time

Burn Wound Clinical Trial

— GE-MTEC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05796492
• Other study ID #: HS-22-00019
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Burn Wound
• Burns
• Wounds and Injuries

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