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Ultrasound Treatment on Wound Healing Time — GE-MTEC  

Burn Wound Clinical Trial

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

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).

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05796492
Study type Interventional
Source General Electric Research
Contact Fabiola Guadalupe Rodriguez
Phone (323) 516-2132
Email fabiola.rodriguez@med.usc.edu
Status Recruiting
Phase N/A
Start date June 22, 2023
Completion date September 1, 2024
View Details
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