Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

SOCKNLEG Compression Stocking Kit: Physical Properties (SOCKNLEGLCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743597
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Venous Insufficiency of Leg Device: SOCKNLEG Device: Sigvaris COTTON Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SOCKNLEG Leg Compression Stocking Kit: Physical Properties: Static Stiffness Index - Venous Ejection Fraction An Open Monocentric Randomized Controlled Cross-over Trial
Estimated Study Start Date : November 19, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: 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.

Device: SOCKNLEG

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


Device: Sigvaris 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


Active Comparator: 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.

Device: SOCKNLEG

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


Device: Sigvaris 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





Primary Outcome Measures :
  1. Static Stiffness Index (SSI) values of both stockings in mmHg measured at point cB1 on the leg [ Time Frame: 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 :
  1. Static Stiffness Index (SSI) values of both stocking in mmHg measured at point cC on the leg [ Time Frame: 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.

  2. Dynamic Stiffness Index (DSI) values of both stockings in mmHg [ Time Frame: 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.

  3. Venous ejection fraction (VEF) of both stockings in % [ Time Frame: 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).

  4. Interface Pressures at point cB on the leg in mmHg [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743597


Contacts
Layout table for location contacts
Contact: Juerg Hafner, M.D. Prof. +41442552533 juerg.hafner@usz.ch
Contact: Caroline S Buset, M.D. +41442551111 caroline.buset@usz.ch

Locations
Layout table for location information
Switzerland
Department of Dermatology, University Hospital of Zurich, Switzerland Recruiting
Zurich, Switzerland, CH-8091
Contact: Juerg Hafner, M.D. Prof.    +41 44 255 25 33    juerg.hafner@usz.ch   
Principal Investigator: Juerg Hafner, M.D. Prof.         
Sponsors and Collaborators
University of Zurich
Investigators
Layout table for investigator information
Principal Investigator: Juerg Hafner, M.D. Prof. Department of Dermatology, University Hospital Zurich, Zurich, Switzerland
Layout table for additonal information
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03743597    
Other Study ID Numbers: SL1726
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases