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

NCT04637997 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-03-16

Study results available
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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).

Conditions

  • Vascular Malformations
  • Vascular Malformation Peripheral
  • Venous Malformation
  • Vascular Diseases

Interventions

DEVICE

compression stockings class I

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

DEVICE

compression stockings class II

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

Sponsors & Collaborators

  • University Hospital Erlangen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2019-03-01
Completion
2020-10-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04637997 on ClinicalTrials.gov