SocknLeg - a User Friendly Medical Compression Study of a Modified Application of a Medical Device (Socknleg)
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|ClinicalTrials.gov Identifier: NCT02621632|
Recruitment Status : Completed
First Posted : December 3, 2015
Last Update Posted : December 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Venous Insufficiency||Device: (Socknleg)To done of a novel compression system||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SocknLeg - a User Friendly Medical Compression Study of a Modified Application of a Medical Device|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Healthy subjects and patients
To done a novel compression system. 20 healthy subjects and 20 patients done a novel compression system termed Socknleg and a compression class III stocking as a comparator.The Socknleg compression system was developed by the investigator and produced by Sigvaris AG, St. Gallen, Switzerland.
Device: (Socknleg)To done of a novel compression system
To done a novel compression system.
- Donning success. [ Time Frame: Successful donning has to be completed within 5 minutes. ]Ability to fully done the investigated compression devices.
- Interface pressure [ Time Frame: Interface pressure is measured within 5 minutes of complete donning of the stocking. ]Interface pressure of the compression systems is measured at level cB1 (transition of the Achilles tendon to the calf muscle) in mmHg by a pressure measuring device termed Picopress® . Interface pressure is compared between the novel compression system and the comparator, a class III compression stocking.
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): NCT02621632
|Department of Dermatology, University Hospital of Zurich, Switzerland|
|Zurich, Switzerland, CH-8091|
|Principal Investigator:||Juerg Hafner, Prof. (MD)||University of Zurich|