Vagal-stimulation-PAVK-tcpO2-study

Study Overview
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Brief Summary
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H-1: tcpO2U2 > tcpO2U1 H-0: tcpO2U2 ≤ tcpO2U1

Official Title
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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

Conditions
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Improvement of Skin Oxygen Supply

Intervention / Treatment
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* Device: Stivax


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stivax<br>an intermittent stimulation of afferent vagus nerve at earlap | Device: Stivax<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in transcutaneous oxygen partial pressure |  | 2015 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in SF 36 |  | 2015 |