Ultrasound Treatment on Wound Healing Time

Stopped early · Not applicable · Has a placebo group

Conditions studied: Burn Wound, 2nd Degree Burn of the Skin

In brief

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).

Key facts

Study ID

NCT05796492

Run by

General Electric Research

People needed

8

Starts

2023-06-22

Expected to finish

2024-12-19

Last updated by the study team

2025-01-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• LAC+USC Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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