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

Vascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637997
• Other study ID #: VM_Compression
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: October 1, 2020

Study information

• Verified date: March 2021
• Source: University Hospital Erlangen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 1, 2020
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Vascular Diseases
• Vascular Malformation Peripheral
• Vascular Malformations
• Venous Malformation

Intervention

Device:
• compression stockings class I
Daily wearing of compression stockings class I for four weeks on the affected extremity.
• compression stockings class II
Daily wearing of compression stockings class II for four weeks on the affected extremity.

Locations

Country	Name	City	State
Germany	University Hospital of Erlangen, Vascular Surgery	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Erlangen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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