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SOCKNLEG Compression Stocking Kit: Physical Properties

NCT03743597 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-03-30

No results posted yet for this study

Summary

This study evaluates physical properties of a innovative leg compression stocking compared to a standard compression stocking of the same compression strength in patients with chronic venous insufficiency clinical stadium C3 and above, according to the CEAP classification for chronic venous insufficiency.

The physical properties can be measured through a series of measurements. The hypothesis is that the innovative compression stocking, although changed in design to be more easily donned, will perform as good as the standard compression stocking.

In each participant the examinations will be conducted with both stockings. A computer generated list will allocate each participant to either one of the stockings, with which the examinations will be conducted first.

Conditions

  • Venous Insufficiency of Leg

Interventions

DEVICE

SOCKNLEG

Innovative multilayer leg compression stocking, compression strength CEN compression class II (European Compression Strength) with compression at the ankle of 23-32mmhg, product composition understocking (polyamide, cotton, spandex), overstocking (polyamide, spandex) In each participant all examinations will be performed with both study stockings, one after the other

DEVICE

Sigvaris COTTON

Standard single leg compression stocking, compression strength CEN compression class II (European Compression Strength) with compression at the ankle of 23-32mmhg, product composition one stocking (polyamide, spandex, cotton) In each participant all examinations will be performed with both study stockings, one after the other

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Juerg Hafner, M.D. Prof. · Department of Dermatology, University Hospital Zurich, Zurich, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03743597 on ClinicalTrials.gov