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临床试验/NCT03854097
NCT03854097已完成不适用

Mechanistic Insights Into Changes in Blood Flow Following Application of Intermittent Negative Pressure

University of Dundee1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2019年2月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
1
主要终点
Change in microvascular endothelial function

研究概览

简要总结

The study will evaluate the effect of intermittent negative pressure (INP) on peripheral arterial disease (PAD) patient vascular function and blood flow. Patients will be given either -40mmHg INP or -10mmHg INP which will act as a placebo. Healthy volunteers will be given -40mmHg INP to evaluate changes in vascular function and blood flow with INP in healthy physiology.

详细描述

Atherosclerosis occurs when blood supply to the lower limbs is restricted upon accumulation of fat in the arteries. Atheroslerosis in the lower limbs is termed peripheral arterial disease (PAD). The initial symptom is pain in the lower limbs followed by ulceration and gangrene. The literature has indicated that intermittent negative pressure (INP) can be used to reduce pain and facilitate wound healing. INP is a non-invasive technique that aims to increase arterial and skin blood flow in lower limbs and foot. This study aims to investigate the underlying mechanisms that are involved in changes in blood flow following application of INP. The Flow-Ox 'boot' will be used to apply INP for periods ranging from 4-8 weeks, for an hour twice per day, to the lower limb to determine the effects of INP on vascular function and blood flow. Specifically, vascular tests such as assessments of endothelial function, arterial stiffness, ankle-brachial pressure index (ABPI) and blood borne metabolic and inflammatory markers will be performed before and after INP application. A pain chart will be employed before and after INP application to determine whether there is any change in perception of pain felt by individuals who suffer from pain associated with lower limb arterial disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in microvascular endothelial function

时间窗: Baseline, 1 day and 4-8 weeks

Peak blood perfusion response to acetylcholine (ACh) delivered by iontophoresis will be measured using a laser Doppler imager.

Change in microvascular blood flow

时间窗: Baseline, 1 day and 4-8 weeks

Microvascular blood flow measurement in foot using laser Dopper imaging.

Change in macrovascular endothelial function

时间窗: Baseline, 1 day and 4-8 weeks

Brachial endothelial function measured as change in brachial blood vessel diameter (%) upon shear stress.

Change in arterial stiffness

时间窗: Baseline, 1 day and 4-8 weeks

Brachial pulse wave analysis (PWA) augmentation index (Ax) and carotid-femoral pulse wave velocity (m/s) (PWV) as an indication of arterial stiffness.

次要结局

  • Change in pain score(Baseline, 1 day and 4-8 weeks)
  • Change in concentration of blood borne inflammatory and oxidative stress biomarkers(Baseline, 1 day and 4-8 weeks)
  • Change in Ankle-Brachial Pressure Index (ABPI)(Baseline, 1 day and 4-8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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