Ultrasound Treatment on Wound Healing Time

Not Applicable

Terminated

• Conditions: 2nd Degree Burn of the Skin; Burn Wound
• Interventions: Device: Pulsed splenic ultrasound; Device: Ultrasound probe (no energy applied)

• Registration Number: NCT05796492
• Lead Sponsor: General Electric Research

Brief 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)

Study Timeline

• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-04-03
• Study Start: 2023-06-22
• Primary Completion: 2024-12-18
• Study Completion: 2024-12-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LOGIQ E10 ultrasound Active	Pulsed splenic ultrasound	The intervention condition will receive 10 minutes of splenic ultrasound daily.
LOGIQ E10 Sham	Ultrasound probe (no energy applied)	The sham condition will consist of the ultrasound probe placed over the spleen with no energy applied.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse device effects (ADEs)	Days 1 -28	Review of anticipated device effects after splenic ultrasound insonification in subjects with partial thickness wounds that cover \<20% body surface area.
Median time to re-epithelialization using advanced digital imaging	28 days or until healed (whichever comes first)	Re-epithelialization measured by digital planimetry

Secondary Outcome Measures

Name	Time	Method
Difference in groups in pain measured visual analog scale, (VAS)	Days 7, 14, 21 and 28	Pain, scale 0-10 with 10 being worst outcome
Difference in groups in itch measured visual analog scale, (VAS)	Days 7, 14, 21 and 28	Itch, scale 0-10 with 10 being worst outcome
Multiplexed analysis of plasma levels of inflammatory cytokines	Days 7, 14, 21 and 28	Plasma levels of inflammatory cytokines, lab range values
Difference in groups in non-invasive perfusion measured visual analog scale, (VAS)	Days 7, 14, 21 and 28	Doppler perfusion, scale 0-10 with 10 being worst outcome
Flow cytometry analysis of phenotype of macrophage, neutrophil, and T lymphocyte populations	Days 7, 14, 21 and 28	Phenotype of macrophage, neutrophil, and T lymphocyte, lab range values
Referral to scar management specialist	Days 7, 14, 21 and 28	Scar management
Scar assessments using Patient and Observer Scar Assessment Scale (POSAS)	Days 7, 14, 21 and 28	A 5 point score ranging from 1 (normal pigmentation, no itching) to 5 (worst imaginable scar or sensation).

Trial Locations

Locations (1)

LAC+USC Medical Center; 🇺🇸 Los Angeles, California, United States