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NCT Number: NCT04637997

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

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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Key information

Conditions

Vascular Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Vascular Diseases Vascular Malformation Peripheral Venous Malformation

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Erlangen, Vascular Surgery

Erlangen, 91054, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

compression stockings class I

Device

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

compression stockings class II

Device

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

Primary outcomes

  1. Volume Difference of Malformation to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by MRI

    Time frame: 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.

  2. Volume Difference of the Affected Extremity to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by Perometre

    Time frame: 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 outcomes

  1. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital Erlangen

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Nov 20, 2020
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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