Ultrasound Treatment on Wound Healing Time (GE-MTEC)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Burn Wound; 2nd Degree Burn of the Skin
• Intervention / Treatment: Device: Ultrasound probe (no energy applied); Device: Pulsed splenic ultrasound

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabiola Guadalupe Rodriguez; Phone Number: (323) 516-2132; Email: fabiola.rodriguez@med.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • LAC+USC Medical Center
      • Principal Investigator: David G Armstrong, DPM, MD, PhD
      • Contact: Elia Salazar Plascencia
      • Contact: Jason Garcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: LOGIQ E10 Sham; The sham condition will consist of the ultrasound probe placed over the spleen with no energy applied.	Device: Ultrasound probe (no energy applied); A General Electric LOGIQ E10 ultrasound probe will be placed over the spleen with no energy applied
Active Comparator: LOGIQ E10 ultrasound Active; The intervention condition will receive 10 minutes of splenic ultrasound daily.	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.; Other Names: Active ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Median time to re-epithelialization using advanced digital imaging	Re-epithelialization measured by digital planimetry	28 days or until healed (whichever comes first)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Referral to scar management specialist	Scar management	Days 7, 14, 21 and 28
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
Multiplexed analysis of plasma levels of inflammatory cytokines	Plasma levels of inflammatory cytokines, lab range values	Days 7, 14, 21 and 28
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

Collaborators and Investigators

• Sponsor: General Electric Research
• Investigators: Principal Investigator: David Armstrong, DPM, MD, PhD, USC Limb Preservation Consortium

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Burns; Wounds and Injuries
• Other Study ID Numbers: HS-22-00019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No