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

Study Overview
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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).

Official Title
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Influence of Flat-knitted Compression Stockings Class I and II on the Morphology of Venous Malformations - Is There a Therapeutic Effect?

Conditions
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Vascular Malformations, Vascular Malformation Peripheral, Venous Malformation, Vascular Diseases

Intervention / Treatment
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* Device: compression stockings class I
* Device: compression stockings class II


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study group 1<br>Wearing of compression stockings class I between Investigation day 28 to 56. Wearing of compression stockings class II between Investigation day 56 to 84. | Device: compression stockings class I<br>* Daily wearing of compression stockings class I for four weeks on the affected extremity.<br>Device: compression stockings class II<br>* Daily wearing of compression stockings class II for four weeks on the affected extremity.<br>|
| Other: Study group 2<br>Wearing of compression stockings class II between Investigation day 28 to 56. Wearing of compression stockings class I between Investigation day 56 to 84. | Device: compression stockings class I<br>* Daily wearing of compression stockings class I for four weeks on the affected extremity.<br>Device: compression stockings class II<br>* Daily wearing of compression stockings class II for four weeks on the affected extremity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume Difference of Malformation to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by MRI | 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. | one day | 
| Volume Difference of the Affected Extremity to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by Perometre | 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. | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | up to two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compression therapy, Compression stockings class I, Compression stockings class II, Short-Form 12 (SF-12), Quality of life, Wearing comfort, Magnetic Resonance Imaging, MRI, Perometre