- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02385981
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
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lower Austria
-
Wiener Neustadt, Lower Austria, Austria, 2700
- Recruiting
- Landesklinikum Wiener Neustadt
-
Contact:
- Thomas Payrits, OA Dr.
- Phone Number: +43/676 83321 2627
- Email: thomas.payrits@wienerneustadt.lknoe.at
-
Principal Investigator:
- Thomas Payrits, OA Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stivax
an intermittent stimulation of afferent vagus nerve at earlap
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in transcutaneous oxygen partial pressure
Time Frame: 2015
|
2015
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
changes in SF 36
Time Frame: 2015
|
2015
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
changes in ambulatory ability
Time Frame: 2015
|
2015
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ASOKLIF 1301/PA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Improvement of Skin Oxygen Supply
-
InMode MD Ltd.CompletedImprovement of Skin AppearanceUnited States
-
NestléCompletedImprovement of FunctionalitySwitzerland
-
Lumenis Be Ltd.CompletedImprovement of Wrinkles/Elastosis as Well as General Skin ToneUnited States
-
BTL Industries Ltd.CompletedImprovement of Abdomen AppearanceBulgaria
-
BTL Industries Ltd.UnknownImprovement of Abdomen AppearanceBulgaria
-
Bangabandhu Sheikh Mujib Medical University, Dhaka...UnknownImprovement of Keratotic Nodular SizeBangladesh
-
Federal University of Health Science of Porto AlegreCompletedEffect of a Program of Deep Inspiration Combined to Expiratory Positive Airway Pressure in AsthmaticImprovement of Functional Capacity. | Improvement of Quality of Life. | Improvement of Cardiovascular Autonomic Control.Brazil
-
Merz North America, Inc.CompletedImprovement of Jawline ContourUnited States
-
South Valley UniversityIbn Sina Hospital; Qena Fertility Center, Qena, EgyptUnknownImprovement of Embryo Transfer Technique | Improvement of Implantation
-
DoczeroLaerdal MedicalUnknownImprovement of BLS/AED Training Programmes