跳至主要内容
临床试验/NCT05749250
NCT05749250招募中不适用

Ultrasound Cavitation for Treatment of Non-healing Ulcers in Critical Limb Ischemia

University of Virginia2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年1月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Lindner, MD

Professor of Medicine, Cardiovascular Medicine

University of Virginia

研究点 (2)

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