Ultrasound Cavitation for Treatment of Non-healing Ulcers in Critical Limb Ischemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Wound dimensions
研究概览
简要总结
In this study, we will explore how ultrasound exposure of ultrasound contrast agents, which produces beneficial shear-mediated bioeffects, can be used to treat patients with severe non-healing ulcers secondary to peripheral arterial disease (PAD). The primary outcome measure is whether ultrasound exposure to microbubble contrast agents in the inflow artery and at the wound site can accelerate wound healing. A secondary outcome measure is whether cavitation-related changes occur in tissue perfusion in the treated limb and wound measured by ultrasound perfusion imaging and skin flow.
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
- 否
入选标准
- •Known history of unilateral or bilateral PAD diagnosed by reduced ankle-brachial index (<0.9) or non-compressible vessels
- •Diagnosis of CLI (Rutherford class IV-VI), and a non-healing ischemic ulcer defined as no change in the prior 3 months.
排除标准
- •Major medical illness other than PAD affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure [NYHA class IV]).
- •Pregnant or lactating females
- •Hypersensitivity to any ultrasound contrast agent or to polyethylene glycol (PEG, macrogol).
- •Hemodynamic instability (hypotension with systolic BP <90 mm Hg, need for vasopressors).
- •Expected amputation or revascularization procedure within the ensuing 1 month.
结局指标
主要结局
Wound dimensions
时间窗: 18 days
Area of non-healing ulcer
次要结局
- Wound granulation(18 days)
- Tissue perfusion(18 days)
研究者
Jonathan Lindner, MD
Professor of Medicine, Cardiovascular Medicine
University of Virginia
