SOCKNLEG Compression Stocking Kit: Physical Properties

NCT03743597 | Unknown DMC

• 1 other identifier: SL1726
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Insufficiency of Leg

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Static Stiffness Index (SSI) values of both stocking in mmHg measured at point cC on the leg

  1 day, during study visit

• Dynamic Stiffness Index (DSI) values of both stockings in mmHg

  1 day, during study visit

• Venous ejection fraction (VEF) of both stockings in %

  1 day, during study visit

• Interface Pressures at point cB on the leg in mmHg

  1 day, during study visit

Study Arms (2)

SOCKNLEG

EXPERIMENTAL

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.

Device: SOCKNLEG; Device: Sigvaris COTTON

Sigvaris COTTON

ACTIVE COMPARATOR

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.

Device: SOCKNLEG; Device: Sigvaris COTTON

Interventions

SOCKNLEG DEVICE

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

SOCKNLEG; Sigvaris COTTON

Sigvaris COTTON DEVICE

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

SOCKNLEG; Sigvaris COTTON

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Dermatology, University Hospital of Zurich, Switzerland

Zurich, CH-8091, Switzerland

RECRUITING

Study Officials

• Juerg Hafner, M.D. Prof.

  Department of Dermatology, University Hospital Zurich, Zurich, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juerg Hafner, M.D. Prof.

CONTACT

+41442552533; juerg.hafner@usz.ch

Caroline S Buset, M.D.

CONTACT

+41442551111; caroline.buset@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 16, 2018
• Study Start: November 19, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)