An interventional study of SOCKNLEG and SIGVARIS Cotton in Venous Insufficiency of Leg, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2019-06-27.
Sponsored by University of Zurich · Not applicable, Interventional, and Treatment
The investigators aim to evaluate the user friendliness of a newly designed leg compression stocking kit, the SOCKNLEG, compared to a standard leg compression stocking of the same compression strength, the SIGVARIS Cotton. The SOCKNLEG is not yet commercially available, whereas the SIGVARIS Cotton has been successfully commercialized for many years.
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.
162 studies on the registry are indexed under Venous Insufficiency; 14 are open to participants now.
This study's enrollment of 47 is below the median of 60 across 127 interventional studies indexed under Venous Insufficiency.
Browse Venous Insufficiency studies →University of Zurich is the lead sponsor of 1,049 studies on the registry; 133 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Device: 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
Device: SIGVARIS Cotton
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
Number of patients who completely don the two investigated leg compression devices
Time frame: through study completion, within 7 months
Number of patients who completely doff the two investigated leg compression devices
Time frame: through study completion, within 7 months
Patient evaluation of user friendliness
Evaluation of user friendliness using the ICC compression questionnaire
Time frame: 3 days
Measuring oedema prevention of the compression stockings by comparison of leg volume measurement at V4 to V3 and V4 to V2.
Assessment by measuring leg volume at the morning visit 3, compared to leg volume at the evening visit 4 and by comparing the leg volumes of visit 4 (compression) to visit 2 (no compression for 1 day)
Time frame: 3 days
Time needed to don and doff the two investigated leg compression
Time in minutes and seconds needed to don and doff each study stocking, measured by study investigator
Time frame: 3 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Jun 2018, 5 months.
Of 37 non-industry interventional studies with no phase under Venous Insufficiency, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 60. This study's 5 months is below that.
Counting every sponsor, half of 46 studies reached it within 15 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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