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

Phase 4

Completed

• Conditions: Venous Insufficiency
• Interventions: Device: (Socknleg)To done of a novel compression system

• Registration Number: NCT02621632
• Lead Sponsor: University of Zurich

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2013-03
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2015-05-22
• Status Verified: 2015-12
• Study First Submitted QC: 2015-12-01
• Last Update Submitted: 2015-12-01
• Study First Posted: 2015-12-03
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 40

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.

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Exclusion Criteria

• Active venous ulcer
• Peripheral arterial disease
• Peripheral neuropathy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy subjects and patients	(Socknleg)To done of a novel compression system	To done a novel compression system. 20 healthy subjects and 20 patients done a novel compression system termed Socknleg and a compression class III stocking as a comparator.The Socknleg compression system was developed by the investigator and produced by Sigvaris AG, St. Gallen, Switzerland.

Primary Outcome Measures

Name	Time	Method
Donning success.	Successful donning has to be completed within 5 minutes.	Ability to fully done the investigated compression devices.

Secondary Outcome Measures

Name	Time	Method
Interface pressure	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.

Trial Locations

Locations (1)

Department of Dermatology, University Hospital of Zurich, Switzerland; 🇨🇭 Zurich, Switzerland