- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03429959
SOCKNLEG Compression Stocking Kit : User Friendliness (SOCKNLEGZH)
SOCKNLEG Compression Stocking Kit User Friendliness: Donning-Doffing-Edema Prevention An Open Monocentric Randomized Controlled Cross-over Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Zurich, Switzerland, CH-8091
- Department of Dermatology, University Hospital of Zurich, Switzerland
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Informed Consent as documented by signature
- 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:
- Venous leg ulcer with a surface >5cm2
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
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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
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Active Comparator: 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
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SIGVARIS Cotton
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients who completely don the two investigated leg compression devices
Time Frame: through study completion, within 7 months
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through study completion, within 7 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients who completely doff the two investigated leg compression devices
Time Frame: through study completion, within 7 months
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through study completion, within 7 months
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Patient evaluation of user friendliness
Time Frame: 3 days
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Evaluation of user friendliness using the ICC compression questionnaire
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3 days
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Measuring oedema prevention of the compression stockings by comparison of leg volume measurement at V4 to V3 and V4 to V2.
Time Frame: 3 days
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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)
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3 days
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Time needed to don and doff the two investigated leg compression
Time Frame: 3 days
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Time in minutes and seconds needed to don and doff each study stocking, measured by study investigator
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3 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Juerg Hafner, Prof., Department of Dermatology, University Hospital Zurich, Zurich, Switzerland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SL1725
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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