Ultrasound Treatment on Wound Healing Time

NCT ID: NCT05796492

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-22
• Study Completion Date: 2024-12-19

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)

Conditions

Burn Wound; 2nd Degree Burn of the Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LOGIQ E10 Sham

The sham condition will consist of the ultrasound probe placed over the spleen with no energy applied.

Group Type: SHAM_COMPARATOR

Ultrasound probe (no energy applied)

Intervention Type: DEVICE

A General Electric LOGIQ E10 ultrasound probe will be placed over the spleen with no energy applied

LOGIQ E10 ultrasound Active

The intervention condition will receive 10 minutes of splenic ultrasound daily.

Group Type: ACTIVE_COMPARATOR

Pulsed splenic ultrasound

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Ultrasound probe (no energy applied)

A General Electric LOGIQ E10 ultrasound probe will be placed over the spleen with no energy applied

Intervention Type: DEVICE

Other Intervention Names

Active ultrasound

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

General Electric Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Armstrong, DPM, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

USC Limb Preservation Consortium

Locations

LAC+USC Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

HS-22-00019

Identifier Type: -

Identifier Source: org_study_id