NCT05796492

Ultrasound Treatment on Wound Healing Time

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: General Electric Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

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

Interventions

Type	Name	Description
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.
DEVICE	Ultrasound probe (no energy applied)	A General Electric LOGIQ E10 ultrasound probe will be placed over the spleen with no energy applied

Timeline

• Start date: 2023-06-22
• Primary completion: 2024-12-18
• Completion: 2024-12-19
• First posted: 2023-04-03
• Last updated: 2025-01-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study