NCT01893840Unknown不适用
Effect on Blood Flow Using the FlowOx™ Device in Patients With Reduced Peripheral Circulation in the Lower Leg
Otivio AS2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- % of the prescribed cycles delivered in the specified time FlowOx™-induced change in arterial leg blood flow (LBF)
研究概览
简要总结
A study to assess the effect of negative pulsating pressure therapy on patients with impaired blood flow to the leg caused by arterial disease, to see if the FlowOx device will increase the blood flow to the leg in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written Informed Consent
- •Age 30-90 years
- •Affected foot/shoe sise less than 46 (approximate foot length less than 29.5 cm)
- •Patients with Peripheral Arterial Occlusive Disease (PAOD) grade 2,3 or 4, i.e.:
- •Clinically verified grade 2, i.e. Intermittent Claudication:
- •Ancle-Brachial Index (ABI)less than 0.9 or
- •Toe brachial Index (TBI) less than 0.7 or
- •Ultrasound and/or CT/Magnetic Resonance (MR) angiography suggesting stenosis(es)and/or occlusion(s)
- •Clinically verified grade 3, i.e. Critical Limb Ischemia (CLI):
- •ABI less than 0.4 or
- •Toe pressure less than 30 mmHg
- •Rest pain since at least 2 weeks or
- •Use of analgesics for rest pain for at least 2 weeks or
- •Ultrasound and/or CT/Magnetic Resonance (MR) angiography suggesting stenosis(es)and/or occlusion(s)
- •Clinically verified grade 4, i.e. CLI:
- •Ischemic ulcers or gangrene/tissue loss
- •ABI less than 0.4
- •Toe pressure less than 30 mmHg
- •Rest pain since at least 2 weeks or
- •Use of analgesics for rest pain for at least 2 weeks or
- •Ultrasound and/or CT/MR angiography suggesting stenosis(es)and/or occlusion(s)
排除标准
- •Grade 1 PAOD
- •Incapable of consenting voluntarily
- •Fewer higher than 39 degrees Centigrade
- •Severe Chronic Obstructive Pulmonary Disease (COPD)
- •Severe heart disease such as unstable angina, severe heart failure and severe valve failure
- •Severe Polyneurophathy
- •Verified Osteomyelitis other than in the Phanlanx
- •Currently treated for cancer and With a life expectancy of less than 2 years
结局指标
主要结局
% of the prescribed cycles delivered in the specified time FlowOx™-induced change in arterial leg blood flow (LBF)
时间窗: up to 1 hour
This is calculated as the difference between the blood flow during the period using FlowOx™ (middle value over a period of 5 minutes) and baseline blood flow (middle value over a period of 5 prior to using FlowOx™)
次要结局
- Patient comfort measured by asking the patient a fixed set of questions(up to 1 hour)
研究者
研究点 (2)
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