Skip to main content
OpenTrials
Completed

NCT Number: NCT02621632

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Venous Insufficiency Cardiovascular Diseases Vascular Diseases

Study type

Interventional

Phase

Phase 4

Primary location

Department of Dermatology, University Hospital of Zurich, Switzerland

Zurich, Canton of Zurich, CH-8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

(Socknleg)To done of a novel compression system

Device

To done a novel compression system.

Primary outcomes

  1. Donning success.

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

    Ability to fully done the investigated compression devices.

Secondary outcomes

  1. Interface pressure

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

    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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Acronym: Socknleg

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 3, 2015
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.