Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
35 participants
INTERVENTIONAL
2018-11-19
2021-12-31
Brief Summary
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The physical properties can be measured through a series of measurements. The hypothesis is that the innovative compression stocking, although changed in design to be more easily donned, will perform as good as the standard compression stocking.
In each participant the examinations will be conducted with both stockings. A computer generated list will allocate each participant to either one of the stockings, with which the examinations will be conducted first.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
The allocated group defines with which stocking the examinations will be conducted first.
TREATMENT
NONE
Study Groups
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SOCKNLEG
Group of participant who will conduct the examinations first with the SOCKNLEG compression stockings.
All examinations will be conducted in all participants and with both stockings one after the other.
SOCKNLEG
Innovative multilayer leg compression stocking, compression strength CEN compression class II (European Compression Strength) with compression at the ankle of 23-32mmhg, product composition understocking (polyamide, cotton, spandex), overstocking (polyamide, spandex)
In each participant all examinations will be performed with both study stockings, one after the other
Sigvaris COTTON
Standard single leg compression stocking, compression strength CEN compression class II (European Compression Strength) with compression at the ankle of 23-32mmhg, product composition one stocking (polyamide, spandex, cotton)
In each participant all examinations will be performed with both study stockings, one after the other
Sigvaris COTTON
Group of participant who will conduct the examinations first with the Sigvaris COTTON compression stockings.
All examinations will be conducted in all participants and with both stockings one after the other.
SOCKNLEG
Innovative multilayer leg compression stocking, compression strength CEN compression class II (European Compression Strength) with compression at the ankle of 23-32mmhg, product composition understocking (polyamide, cotton, spandex), overstocking (polyamide, spandex)
In each participant all examinations will be performed with both study stockings, one after the other
Sigvaris COTTON
Standard single leg compression stocking, compression strength CEN compression class II (European Compression Strength) with compression at the ankle of 23-32mmhg, product composition one stocking (polyamide, spandex, cotton)
In each participant all examinations will be performed with both study stockings, one after the other
Interventions
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SOCKNLEG
Innovative multilayer leg compression stocking, compression strength CEN compression class II (European Compression Strength) with compression at the ankle of 23-32mmhg, product composition understocking (polyamide, cotton, spandex), overstocking (polyamide, spandex)
In each participant all examinations will be performed with both study stockings, one after the other
Sigvaris COTTON
Standard single leg compression stocking, compression strength CEN compression class II (European Compression Strength) with compression at the ankle of 23-32mmhg, product composition one stocking (polyamide, spandex, cotton)
In each participant all examinations will be performed with both study stockings, one after the other
Eligibility Criteria
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Inclusion Criteria
* Male or post-menopausal women over the age of 65
* Diagnosed chronic venous insufficiency stage C3-C6 (according to CEAP classification)
* Indication of a compression therapy by medical compression stocking
Exclusion Criteria
* Suspected polyneuropathy with ≤4 sensible test areas measured with the Semmes- Weinstein-Monofilament-Test
* Advanced heart insufficiency (NYHA III-IV)
* Contraindications to compression therapy
* Known allergies to any components of the stocking material
* Inability to follow the procedures of the study
65 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Juerg Hafner, M.D. Prof.
Role: PRINCIPAL_INVESTIGATOR
Department of Dermatology, University Hospital Zurich, Zurich, Switzerland
Locations
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Department of Dermatology, University Hospital of Zurich, Switzerland
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SL1726
Identifier Type: -
Identifier Source: org_study_id
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