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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COMPLETED
NA
47 participants
INTERVENTIONAL
2018-01-10
2018-06-30
Brief Summary
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After an initial screening visit, a computer generated list will allocate the participants in either the SOCKNLEG or the SIGVARIS Cotton group.
All participants will try on both study stockings, in the order of their allocated group, and will rate their donning and doffing success with a questionnaire. The patients will then wear only the assigned study stocking of their allocated group, for a day and rate its comfort again at the end of the day. The donning and doffing success will also be rated by the study investigator. Leg volume measurements of the study leg will be taken at each visit to determine edema prevention.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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SOCKNLEG
Donning and doffing success of the study stocking compared with both stockings, wearing of the study stocking for a day, standardized non invasive measurement to calculate leg volume of the study leg
SOCKNLEG
Donning and doffing success compared with the two study stockings, wearing the assigned study stocking for a day, Patient Quesationnaire on donning and doffing success and wearing comfort of each study stocking
SIGVARIS Cotton
Donning and doffing success of the study stocking compared with both stockings, wearing of the study stocking for a day, standardized non invasive measurement to calculate leg volume of the study leg
SIGVARIS Cotton
SIGVARIS Cotton
Interventions
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SOCKNLEG
Donning and doffing success compared with the two study stockings, wearing the assigned study stocking for a day, Patient Quesationnaire on donning and doffing success and wearing comfort of each study stocking
SIGVARIS Cotton
SIGVARIS Cotton
Eligibility Criteria
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Inclusion Criteria
* Male or postmenopausal female patient, aged over 65 years of age
* Diagnosed venous insufficiency stage C3-C6 (according to CEAP (Clinical, Etiologic, Anatomic, Pathophysiologic) -classification for venous diseases)
Exclusion Criteria
* Peripheral artery disease (PAD) or media calcinosis (Ankle-Brachial-Index \<0.8 or \>1.3)
* Difference in brachial blood pressure \>20mmHg in both arms
* Suspected polyneuropathy with ≥4 sensible test areas, measured with the Semmes-Weinstein-Monofilament-Test
* Inability to reach the forefoot with their hands
* Inability to follow the procedures of the study
* Bed-ridden hospitalized patients who are not able to leave the bed or sit upright for a few consecutive hours
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, 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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Other Identifiers
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SL1725
Identifier Type: -
Identifier Source: org_study_id
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