Clinical trial NCT03743597: SOCKNLEG Compression Stocking Kit: Physical Properties
Official title: SOCKNLEG Leg Compression Stocking Kit: Physical Properties: Static Stiffness Index - Venous Ejection Fraction An Open Monocentric Randomized Controlled Cross-over Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Insufficiency of Leg
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 35
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A computer generated list will allocate each participant to either one of the stockings, the innovative SOCKNLEG, or the standard Sigvaris COTTON stocking. In each participant the examinations will be conducted with both stockings.

The allocated group defines with which stocking the examinations will be conducted first.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Static Stiffness Index (SSI) values of both stockings in mmHg measured at point cB1 on the leg
timeFrame: 1 day, during study visit
Secondary outcomes:
measure: Static Stiffness Index (SSI) values of both stocking in mmHg measured at point cC on the leg
timeFrame: 1 day, during study visit
measure: Dynamic Stiffness Index (DSI) values of both stockings in mmHg
timeFrame: 1 day, during study visit
measure: Venous ejection fraction (VEF) of both stockings in %
timeFrame: 1 day, during study visit
measure: Interface Pressures at point cB on the leg in mmHg
timeFrame: 1 day, during study visit
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Dermatology, University Hospital of Zurich, Switzerland
Study officials:
affiliation: Department of Dermatology, University Hospital Zurich, Zurich, Switzerland
name: Juerg Hafner, M.D. Prof.
role: PRINCIPAL_INVESTIGATOR
References: