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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
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
The study intends to investigate a novel compression system termed Socknleg composed of an understocking covering the foot with three added stockings extending from the ankle to the knee without covering the foot. The novel Socknleg system is compared to a standard class III compression stocking.

Condition or disease Intervention/treatment Phase
Venous Insufficiency Device: (Socknleg)To done of a novel compression system Phase 4

Detailed Description:
The investigator tests a novel compression system termed Socknleg in 20 healthy individuals and 20 patients with chronic venous disease. Socknleg is composed of an understocking covering the foot with three added stockings extending from the ankle to the knee without covering the foot. The novel Socknleg system is compared to a standard class III compression stocking. Outcome measures are successful donning and the comparison of interface pressure measured on the level of the ankle.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Donning success. [ Time Frame: Successful donning has to be completed within 5 minutes. ]
    Ability to fully done the investigated compression devices.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers: age > 18 years, proband information read, consent form signed
  • Patients: age > 18 years, chronic venous insufficiency CEAP C5 (healed venous ulcer).Age > 18 year, patient information read, consent signed.

Exclusion Criteria:

  • Active venous ulcer
  • Peripheral arterial disease
  • Peripheral neuropathy

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): NCT02621632


Locations
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Switzerland
Department of Dermatology, University Hospital of Zurich, Switzerland
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Juerg Hafner, Prof. (MD) University of Zurich

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02621632     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2013-091
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015
Keywords provided by University of Zurich:
Compression therapy
Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases