SOCKNLEG Compression Stocking Kit: Physical Properties

Venous Insufficiency of Leg Clinical Trial

— SOCKNLEGLCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03743597
• Other study ID #: SL1726
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: University of Zurich
• Contact: Juerg Hafner, M.D. Prof.
• Phone: +41442552533
• Email: juerg.hafner[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Venous Insufficiency
• Venous Insufficiency of Leg

Intervention

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
• 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

Locations

Country	Name	City	State
Switzerland	Department of Dermatology, University Hospital of Zurich, Switzerland	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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