Clinical trial NCT05796492: Ultrasound Treatment on Wound Healing Time
Official title: Fieldable Ultrasound Treatment to Enhance Inflammatory-Proliferative Phase Transition and Reduce Wound Healing Time
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Burn Wound
2nd Degree Burn of the Skin
Lead sponsor: General Electric Research
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Incidence and severity of adverse device effects (ADEs)
timeFrame: Days 1 -28
measure: Median time to re-epithelialization using advanced digital imaging
timeFrame: 28 days or until healed (whichever comes first)
Secondary outcomes:
measure: Difference in groups in pain measured visual analog scale, (VAS)
timeFrame: Days 7, 14, 21 and 28
measure: Difference in groups in itch measured visual analog scale, (VAS)
timeFrame: Days 7, 14, 21 and 28
measure: Difference in groups in non-invasive perfusion measured visual analog scale, (VAS)
timeFrame: Days 7, 14, 21 and 28
measure: Referral to scar management specialist
timeFrame: Days 7, 14, 21 and 28
measure: Scar assessments using Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: Days 7, 14, 21 and 28
measure: Multiplexed analysis of plasma levels of inflammatory cytokines
timeFrame: Days 7, 14, 21 and 28
measure: Flow cytometry analysis of phenotype of macrophage, neutrophil, and T lymphocyte populations
timeFrame: Days 7, 14, 21 and 28
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LAC+USC Medical Center
state: California
Study officials:
affiliation: USC Limb Preservation Consortium
name: David Armstrong, DPM, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: