SOCKNLEG Compression Stocking Kit: Physical Properties

NCT ID: NCT03743597

Last Updated: 2021-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-19

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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Venous Insufficiency of Leg

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SOCKNLEG

Intervention Type 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

Sigvaris COTTON

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

SOCKNLEG

Intervention Type 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

Sigvaris COTTON

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juerg Hafner, M.D. Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, University Hospital Zurich, Zurich, Switzerland

Locations

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Department of Dermatology, University Hospital of Zurich, Switzerland

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Juerg Hafner, M.D. Prof.

Role: CONTACT

+41442552533

Caroline S Buset, M.D.

Role: CONTACT

+41442551111

Facility Contacts

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Juerg Hafner, M.D. Prof.

Role: primary

+41 44 255 25 33

Other Identifiers

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SL1726

Identifier Type: -

Identifier Source: org_study_id

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