SOCKNLEG Compression Stocking Kit: Physical Properties

University of Zurich35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Venous Insufficiency of Leg

Interventions

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

Sigvaris COTTONDEVICE

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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Informed Consent as documented by signature * Male or post-menopausal women over the age of 65 * Diagnosed chronic venous insufficiency stage C3-C6 (according to CEAP classification) * Indication of a compression therapy by medical compression stocking Exclusion Criteria: * Peripheral artery disease (PAD) or calcinosis (Ankle-Brachial-Index \<0.8 or \>1.3 * Suspected polyneuropathy with ≤4 sensible test areas measured with the Semmes- Weinstein-Monofilament-Test * Advanced heart insufficiency (NYHA III-IV) * Contraindications to compression therapy * Known allergies to any components of the stocking material * Inability to follow the procedures of the study

Outcomes

Primary Outcomes

Static Stiffness Index (SSI) values of both stockings in mmHg measured at point cB1 on the leg

The SSI is a substraction of the Interface Pressures measured with a pressure probe on the leg of the study participant in standing and in supine position while wearing a compression stocking. The point cB1 is a thereby a standard measuring point at the distal insertion of the gastrocnemius muscle of the leg.