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SOCKNLEG Compression Stocking Kit : User Friendliness (SOCKNLEGZH)

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ClinicalTrials.gov Identifier: NCT03429959
Recruitment Status : Completed
First Posted : February 12, 2018
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Venous Insufficiency of Leg Device: SOCKNLEG Device: SIGVARIS Cotton Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SOCKNLEG Compression Stocking Kit User Friendliness: Donning-Doffing-Edema Prevention An Open Monocentric Randomized Controlled Cross-over Trial
Actual Study Start Date : January 10, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

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Arms and Interventions
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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
 Device: 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
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
 Device: SIGVARIS Cotton
SIGVARIS Cotton


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients who completely don the two investigated leg compression devices [ Time Frame: through study completion, within 7 months ]

Secondary Outcome Measures :
  1. Number of patients who completely doff the two investigated leg compression devices [ Time Frame: through study completion, within 7 months ]
  2. Patient evaluation of user friendliness [ Time Frame: 3 days ]
    Evaluation of user friendliness using the ICC compression questionnaire

  3. 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 ]
    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)

  4. Time needed to don and doff the two investigated leg compression [ Time Frame: 3 days ]
    Time in minutes and seconds needed to don and doff each study stocking, measured by study investigator


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT03429959


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. Department of Dermatology, University Hospital Zurich, Zurich, Switzerland
More Information
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03429959    
Other Study ID Numbers: SL1725
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases