Venous Insufficiency of Leg
Conditions
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.
Interventions
DEVICESOCKNLEG
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
DEVICESigvaris 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
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Static Stiffness Index (SSI) values of both stockings in mmHg measured at point cB1 on the leg | 1 day, during study visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Static Stiffness Index (SSI) values of both stocking in mmHg measured at point cC on the leg | 1 day, during study visit | 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. |
| Dynamic Stiffness Index (DSI) values of both stockings in mmHg | 1 day, during study visit | 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. |
| Venous ejection fraction (VEF) of both stockings in % | 1 day, during study visit | Non-invasive measurement of the venous filling volumes of the leg with a strain gauge plethysmography the Angioflow2 (Microlabitalia, Padua, Italy). |
| Interface Pressures at point cB on the leg in mmHg | 1 day, during study visit | 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. |
Countries
Switzerland
Contacts
Primary ContactJuerg Hafner, M.D. Prof.
Backup ContactCaroline S Buset, M.D.
Outcome results
None listed