SocknLeg - a User Friendly Medical Compression Study of a Modified Application of a Medical Device

University of Zurich40 enrolled

Overview

The study intends to investigate a novel compression system termed Socknleg composed of an understocking covering the foot with three added stockings extending from the ankle to the knee without covering the foot. The novel Socknleg system is compared to a standard class III compression stocking.

The investigator tests a novel compression system termed Socknleg in 20 healthy individuals and 20 patients with chronic venous disease. Socknleg is composed of an understocking covering the foot with three added stockings extending from the ankle to the knee without covering the foot. The novel Socknleg system is compared to a standard class III compression stocking. Outcome measures are successful donning and the comparison of interface pressure measured on the level of the ankle.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Venous Insufficiency

Interventions

(Socknleg)To done of a novel compression systemDEVICE

To done a novel compression system.

Eligibility

Healthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy volunteers: age \> 18 years, proband information read, consent form signed * Patients: age \> 18 years, chronic venous insufficiency CEAP C5 (healed venous ulcer).Age \> 18 year, patient information read, consent signed. Exclusion Criteria: * Active venous ulcer * Peripheral arterial disease * Peripheral neuropathy

Locations (1)

Department of Dermatology, University Hospital of Zurich, Switzerland

Zurich, Canton of Zurich, Switzerland

Outcomes

Primary Outcomes

Donning success.

Ability to fully done the investigated compression devices.

Time frame: Successful donning has to be completed within 5 minutes.

Secondary Outcomes

Interface pressure

Interface pressure of the compression systems is measured at level cB1 (transition of the Achilles tendon to the calf muscle) in mmHg by a pressure measuring device termed Picopress® . Interface pressure is compared between the novel compression system and the comparator, a class III compression stocking.

Time frame: Interface pressure is measured within 5 minutes of complete donning of the stocking.

Data from ClinicalTrials.gov

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