Fieldable Ultrasound Treatment to Enhance Inflammatory-Proliferative Phase Transition and Reduce Wound Healing Time
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Incidence and severity of adverse device effects (ADEs)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence and severity of adverse device effects (ADEs)
时间窗: Days 1 -28
Review of anticipated device effects after splenic ultrasound insonification in subjects with partial thickness wounds that cover \<20% body surface area.
Median time to re-epithelialization using advanced digital imaging
时间窗: 28 days or until healed (whichever comes first)
Re-epithelialization measured by digital planimetry
次要结局
- Difference in groups in pain measured visual analog scale, (VAS)(Days 7, 14, 21 and 28)
- Difference in groups in itch measured visual analog scale, (VAS)(Days 7, 14, 21 and 28)
- Multiplexed analysis of plasma levels of inflammatory cytokines(Days 7, 14, 21 and 28)
- Difference in groups in non-invasive perfusion measured visual analog scale, (VAS)(Days 7, 14, 21 and 28)
- Flow cytometry analysis of phenotype of macrophage, neutrophil, and T lymphocyte populations(Days 7, 14, 21 and 28)
- Referral to scar management specialist(Days 7, 14, 21 and 28)
- Scar assessments using Patient and Observer Scar Assessment Scale (POSAS)(Days 7, 14, 21 and 28)