SOCKNLEG Compression Stocking Kit: Physical Properties (SOCKNLEGLCA)

University of Zurich (UZH)

Status: Unknown

Conditions: Venous Insufficiency of Leg

Treatments: Device: SOCKNLEG; Device: Sigvaris COTTON

Study type: Interventional

Funder types: Other

Identifiers

NCT03743597

SL1726

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

35 participants in 2 patient groups

SOCKNLEG

Experimental group

Description:

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.

Treatment:

Device: SOCKNLEG

Device: Sigvaris COTTON

Sigvaris COTTON

Active Comparator group

Description:

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.

Treatment:

Device: SOCKNLEG

Device: Sigvaris COTTON