Influence of Flat-knitted Compression Stockings Class I and II on Venous Malformations

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2020-10-01

Brief Summary

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Diseases with vascular malformations are rare and often congenital, affecting patients of all ages. Depending on their extent and localization, they can cause discomfort and, especially if activity is restricted, lead to loss or reduced quality of life.

The therapy is usually reserved for a few specialized centers and includes interventional sclerotherapy as well as conservative therapy by compression with appropriate compression stockings. However, there are currently no study-based recommendations for this approach.

The aim of this study is to prove a therapeutic effect of compression therapy using flat-knitted compression stockings on venous malformations of the extremities and to derive from this a therapy recommendation in connection with an improvement in the health status and quality of life.

For this purpose, patients with a confirmed venous malformation of the upper or lower extremity independent of previous therapy will be included. We will investigate patients with epi- and/or subfascial localization of the venous malformation independent of the local extent (cross-articular or not).

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Detailed Description

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Conditions

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Vascular Malformations Vascular Malformation Peripheral Venous Malformation Vascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a single group study with crossover components. Participants receive randomly and double-blinded either class I compression stockings or class II compression stockings. After four weeks, an exchange of compression classes takes place, so that all participants wear both classes of compression stockings within eight weeks.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double-blind study. Neither investigator nor patient knows the compression class (class I versus class II) of the compression stockings used in the different investigation periods in this patient.

Study Groups

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Study group 1

Wearing of compression stockings class I between Investigation day 28 to 56. Wearing of compression stockings class II between Investigation day 56 to 84.

Group Type OTHER

compression stockings class I

Intervention Type DEVICE

Daily wearing of compression stockings class I for four weeks on the affected extremity.

compression stockings class II

Intervention Type DEVICE

Daily wearing of compression stockings class II for four weeks on the affected extremity.

Study group 2

Wearing of compression stockings class II between Investigation day 28 to 56. Wearing of compression stockings class I between Investigation day 56 to 84.

Group Type OTHER

compression stockings class I

Intervention Type DEVICE

Daily wearing of compression stockings class I for four weeks on the affected extremity.

compression stockings class II

Intervention Type DEVICE

Daily wearing of compression stockings class II for four weeks on the affected extremity.

Interventions

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compression stockings class I

Daily wearing of compression stockings class I for four weeks on the affected extremity.

Intervention Type DEVICE

compression stockings class II

Daily wearing of compression stockings class II for four weeks on the affected extremity.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with a confirmed venous malformation of the upper/lower extremity independent of previous therapy with epi- and/or subfascial localization of the venous malformation independent of the local extent (cross-articular or not)
* Compression stocking can be put on independently or by the parents
* Written declaration of consent present

Exclusion Criteria

* Lack of compliance, patient is not available for control appointments
* Additional drug therapy (anticoagulation) for extensive venous malformations with threatening thromboembolic complications
* Known allergic reaction/intolerance to components of flat-knitted compression stockings
* Pregnancy
* Rejection of the study participation by the patient
* Contraindications for the planned MRI examination (pacemakers, implants not suitable for MRI, claustrophobia)
* Occurrence of an emergency situation
* Severe heart failure as contraindication for compression therapy
* Peripheral arterial disease as contraindication for compression therapy

Eligible Sex

ALL

Accepts Healthy Volunteers

No