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

Not Applicable

Completed

Conditions: Vascular Malformations
Venous Malformation
Vascular Malformation Peripheral
Vascular Diseases

Interventions: Device: compression stockings class I
Device: compression stockings class II

Brief Summary: 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Study group 2	compression stockings class II	Wearing of compression stockings class II between Investigation day 28 to 56. Wearing of compression stockings class I between Investigation day 56 to 84.
Study group 1	compression stockings class II	Wearing of compression stockings class I between Investigation day 28 to 56. Wearing of compression stockings class II between Investigation day 56 to 84.
Study group 2	compression stockings class I	Wearing of compression stockings class II between Investigation day 28 to 56. Wearing of compression stockings class I between Investigation day 56 to 84.
Study group 1	compression stockings class I	Wearing of compression stockings class I between Investigation day 28 to 56. Wearing of compression stockings class II between Investigation day 56 to 84.

Primary Outcome Measures

Name	Time	Method
Volume Difference of Malformation to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by MRI	one day	Determination and comparison of volume difference of the malformation after application of compression stockings class I and II compared to baseline (no compression) measured non-invasively by MRI.
Volume Difference of the Affected Extremity to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by Perometre	one day	Determination and comparison of volume difference of the affected extremity after application of compression stockings class I and II compared to baseline (no compression) measured non-invasively by perometre.

Secondary Outcome Measures

Name	Time	Method
Difference Between Quality of Life at Baseline (no Compression at Day 28) and Compression Classes I and II by Short Form-12 (SF-12) Health Survey at Day 56 or 84	up to two months	SF-12v2 (SOEP-Version 2004) scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental (MCS) and physical (PCS) functioning and overall health-related quality of life. A higher value indicates a better quality of life of the patient. The scores range from 0 to 100. The overall mean for each scale is 50 points and the standard deviation is 10 points in the SOEP sample.