Ultrasound Treatment on 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).
Conditions:
🦠 Burn Wound 🦠 2nd Degree Burn of the Skin
🗓️ Study Start (Actual) 22 June 2023
🗓️ Primary Completion (Estimated) 1 September 2024
✅ Study Completion (Estimated) 1 September 2024
👥 Enrollment (Estimated) 24
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Los Angeles, California, United States

📋 Eligibility Criteria

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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 22 August 2022
  • First Submitted that Met QC Criteria 30 March 2023
  • First Posted 3 April 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 January 2024
  • Last Update Posted 12 January 2024
  • Last Verified May 2023