SOCKNLEG Compression Stocking Kit : User Friendliness (SOCKNLEGZH)

June 26, 2019 updated by: University of Zurich

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

Completed

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zurich, Switzerland, CH-8091
        • Department of Dermatology, University Hospital of Zurich, Switzerland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
SIGVARIS Cotton

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
through study completion, within 7 months

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
through study completion, within 7 months
Patient evaluation of user friendliness
Time Frame: 3 days
Evaluation of user friendliness using the ICC compression questionnaire
3 days
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)
3 days
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
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Juerg Hafner, Prof., Department of Dermatology, University Hospital Zurich, Zurich, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2018

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

December 15, 2017

First Submitted That Met QC Criteria

February 5, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

June 27, 2019

Last Update Submitted That Met QC Criteria

June 26, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • SL1725

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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