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Vagal-stimulation-PAVK-tcpO2-study

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ClinicalTrials.gov Identifier: NCT02385981
Recruitment Status : Unknown
Verified March 2015 by Payrits, Thomas, M.D..
Recruitment status was:  Recruiting
First Posted : March 11, 2015
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
Payrits, Thomas, M.D.

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

Condition or disease Intervention/treatment Phase
Improvement of Skin Oxygen Supply Device: Stivax Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : April 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Stivax
an intermittent stimulation of afferent vagus nerve at earlap
Device: Stivax



Primary Outcome Measures :
  1. change in transcutaneous oxygen partial pressure [ Time Frame: 2015 ]

Secondary Outcome Measures :
  1. changes in SF 36 [ Time Frame: 2015 ]

Other Outcome Measures:
  1. changes in ambulatory ability [ Time Frame: 2015 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. PAVK stadium IIb due to Fontaine for at least 6 month
  3. reduced systolic occlusion pressure at ankle (arteria tibialis posterior and anterior): ABI <0,9
  4. 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)
  5. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385981


Contacts
Contact: Thomas Payrits, OA Dr. +43/676833212627 thomas.payrits@wienerneustadt.lknoe.at

Locations
Austria
Landesklinikum Wiener Neustadt Recruiting
Wiener Neustadt, Lower Austria, Austria, 2700
Contact: Thomas Payrits, OA Dr.    +43/676 83321 2627    thomas.payrits@wienerneustadt.lknoe.at   
Principal Investigator: Thomas Payrits, OA Dr.         
Sponsors and Collaborators
Payrits, Thomas, M.D.

Responsible Party: Payrits, Thomas, M.D.
ClinicalTrials.gov Identifier: NCT02385981     History of Changes
Other Study ID Numbers: ASOKLIF 1301/PA
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015