SOCKNLEG Compression Stocking Kit: Physical Properties (SOCKNLEGLCA)

SOCKNLEG Leg Compression Stocking Kit: Physical Properties: Static Stiffness Index - Venous Ejection Fraction An Open Monocentric Randomized Controlled Cross-over Trial

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 Overview

• Status: Recruiting
• Conditions: Venous Insufficiency of Leg
• Intervention / Treatment: Device: SOCKNLEG; Device: Sigvaris COTTON

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juerg Hafner, M.D. Prof.; Phone Number: +41442552533; Email: juerg.hafner@usz.ch
• Study Contact Backup: Name: Caroline S Buset, M.D.; Phone Number: +41442551111; Email: caroline.buset@usz.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, CH-8091
    • Recruiting
    • Department of Dermatology, University Hospital of Zurich, Switzerland
    • Contact: Juerg Hafner, M.D. Prof.; Phone Number: +41 44 255 25 33; Email: juerg.hafner@usz.ch
    • Principal Investigator: Juerg Hafner, M.D. Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOCKNLEG; Group of participant who will conduct the examinations first with the SOCKNLEG compression stockings. All examinations will be conducted in all participants and with both stockings one after the other.	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
Active Comparator: Sigvaris COTTON; Group of participant who will conduct the examinations first with the Sigvaris COTTON compression stockings. All examinations will be conducted in all participants and with both stockings one after the other.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day, during study visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static Stiffness Index (SSI) values of both stocking in mmHg measured at point cC on the leg	Comparing the SSI at point cC of both stockings with each other and with the standard SSI values at point cB1. The point cC is a new measuring point at the largest circumference of the calf.	1 day, during study visit
Dynamic Stiffness Index (DSI) values of both stockings in mmHg	The DSI is a substraction of the Interface Pressures measured at each point (cC and cB1) on the leg during wiping of the foot while wearing a compression stocking. Measuring instruments are again the pressure probes.	1 day, during study visit
Venous ejection fraction (VEF) of both stockings in %	Non-invasive measurement of the venous filling volumes of the leg with a strain gauge plethysmography the Angioflow2 (Microlabitalia, Padua, Italy).	1 day, during study visit
Interface Pressures at point cB on the leg in mmHg	The point cB is the point of the smallest circumference of the leg and is the standard measuring point for compression strength of a leg compression stocking. Measured with a pressure probe on the leg of the study participant under the compression stocking.	1 day, during study visit

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Juerg Hafner, M.D. Prof., Department of Dermatology, University Hospital Zurich, Zurich, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: November 13, 2018
• First Submitted That Met QC Criteria: November 13, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: SL1726

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No