Vagal-stimulation-PAVK-tcpO2-study
Clinical Study to Review the Effects of an Auricular and Percutaneous Electric Stimulation of Nervus Vagus on the Oxygen Supply of Skin of Patients With Severe Claudicatio Intermittens
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Lower Austria
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Wiener Neustadt、Lower Austria、奥地利、2700
- 招聘中
- Landesklinikum Wiener Neustadt
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接触:
- Thomas Payrits, OA Dr.
- 电话号码:+43/676 83321 2627
- 邮箱:thomas.payrits@wienerneustadt.lknoe.at
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首席研究员:
- Thomas Payrits, OA Dr.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Each subject must sign an informed consent (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.
- PAVK stadium IIb due to Fontaine for at least 6 month
- reduced systolic occlusion pressure at ankle (arteria tibialis posterior and anterior): ABI <0,9
- radiologic significant occlusion at arteria femoralis superficialis and/or at arteria poplitea and/or at arteria of lower legs (MRT, CT, CO2-angiography or color-coded duplex sonography)
- expected availability during study participation over 12 weeks (via health care center)
Exclusion Criteria:
1) <18 years 2) pregnancy and non-exclusion of pregnancy (women of child-bearing potential)
3)risk of incidence of pregnancy during study participation (female must fulfill one of the following criteria: menopause for more than 2 years, postmenopausal sterilisation, surgical sterilisation, hormonal contrazeption during study participation, spiral or diaphragm/condome+spermicide).
4) lactation period 5) person of legal incapacity 6) regard, placement or appointment of an solicitor 7) military service 8) contraindication for the application of STIVAX 8a) malignant tumour (existence of a known, histologic verified, malignant tumour) 8b) hemophilia 8c) psoriasis vulgaris 8d) recent stroke 8e) superficial and deep infection of auricle and external auditory canal 9) (with the exception of STIVAX-application): foreseeable relevant stimulation of afferent contents of vagus to the ear within next 2 weeks.
10) isolated diabetic microangiopathia 11) implantated cardiac pacemaker or defibrillator 12) transcutaneous partial pressure of oxygen (tcpO2) > 50 mmHg 13) concomitant disease with potential to limit the significance of the investigation of the walk distance (angina pectoris, heart failure, relevant pulmonary disease, relevant orthopedic or neurologic disease) 14) concomitant disease with potential to improve or to worsen the walking or the perfusion of the extremities in a relevant way.
15) foreseeable change of PAVK-relevant medication or of concomitant medication with the potential to improve or to worsen the walking or the perfusion of the extremities in a relevant way within next 2 weeks.
16) foreseeable start of a structured walking training within the next 2 weeks. 17) change in PAVK relevant medication or concomitant medication with potential to improve or worsen the walking or the perfusion of the extremities in a relevant way within the last 3 months.
18) start with structured walking training within the last 3 months. 19) change in smoking habits within the last 3 months. 20) simultaneous participation in another clinical trial with insurance-protection.
21) use of a therapy with stimulation of the afferent parts of vagus on the ear in the past.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Stivax
an intermittent stimulation of afferent vagus nerve at earlap
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
change in transcutaneous oxygen partial pressure
大体时间:2015
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2015
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次要结果测量
结果测量 |
大体时间 |
---|---|
changes in SF 36
大体时间:2015
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2015
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其他结果措施
结果测量 |
大体时间 |
---|---|
changes in ambulatory ability
大体时间:2015
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2015
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- ASOKLIF 1301/PA
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.