SOCKNLEG Compression Stocking Kit: Physical Properties
- Conditions
- Venous Insufficiency of Leg
- Interventions
- Device: SOCKNLEGDevice: Sigvaris COTTON
- Registration Number
- NCT03743597
- Lead Sponsor
- University of Zurich
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 35
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description SOCKNLEG Sigvaris COTTON 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. Sigvaris COTTON SOCKNLEG 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. SOCKNLEG 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. Sigvaris COTTON 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Department of Dermatology, University Hospital of Zurich, Switzerland
🇨🇭Zurich, Switzerland