Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease: Effects After Long-term Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- Change in maximal walking distance
研究概览
简要总结
Studies have shown that intermittent negative pressure (INP) can induce short-term increase in blood flow in the extremity in patients with peripheral artery disease (PAD). Case reports also have indicated that INP treatment has beneficial hemodynamic and clinical effects in patients with lower limb ischemia and hard to heal leg ulcers. However, the clinical and physiological effects of long-term INP treatment are not well documented and needs further investigation.
详细描述
A double-blinded randomized sham-controlled trial.
Otivio AS is the developer of FlowOx, a noninvasive CE marked device to increase blood flow to the lower extremity. The device acts as a pressure chamber sealed around the patient's lower leg, applying pulses of intermittent negative pressure and atmospheric pressure. The pressure pulses are generated by a control unit, alternating between removing air from- and venting the pressure chamber.
Preliminary tests indicate a significant increase in blood flow to the extremity during INP treatment at -40 mmHg, but a similar increase in blood flow was not detected during treatment INP treatment at -10 mmHg. Hence, treatment with -10 mmHg, may serve as a sham intervention, when evaluating the clinical and physiological effects of long-term INP treatment.
All patients will receive best medical treatment including advice for smoking cessation, dietary advice, and advice for physical exercise, and pharmacological treatment with statins and platelet inhibitors. Patients will be randomized into two groups, one group receiving INP treatment with a pressure of -10 mmHg, the other group receiving INP treatment with a pressure of -40 mmHg. Treatment will be conducted by the patient him/herself at home, one hour in the morning and one hour in the evening for 12 weeks.
Pain-free- and maximal walking distance, ankle-brachial index, arterial blood flow during application of INP, maximal blood flow, and biomarkers of inflammation and endothelial dysfunction will be registered at baseline and after 12 weeks to evaluate the effects of long-term INP treatment.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ankle-Brachial Index < 0,9, and intermittent claudication
排除标准
- •Incapable to make an informed consent
- •Inability to perform a treadmill test
- •Inability to independently operate FlowOx
- •Severe heart disease such as unstable angina pectoris, severe heart failure (NYHA IV), severe valve failure
- •Severe COPD
结局指标
主要结局
Change in maximal walking distance
时间窗: At baseline and after 12 weeks of treatment
Treadmill test
Change in pain-free walking distance
时间窗: At baseline and after 12 weeks of treatment
Treadmill test
次要结局
- Changes in resting and maximal blood flow(At baseline and after 12 weeks)
- Change in serum levels of markers of inflammation and endothelial dysfunction(At baseline and after 12 weeks)
- Changes in arterial blood flow during application of INP(At baseline and after 12 weeks)
- Changes in Ankle-Brachial Index(At baseline and after 12 weeks)
研究者
Jonny Hisdal
Principal Investigator
Oslo University Hospital