Clinical trial NCT04637997: Influence of Flat-knitted Compression Stockings Class I and II on Venous Malformations
Official title: Influence of Flat-knitted Compression Stockings Class I and II on the Morphology of Venous Malformations - Is There a Therapeutic Effect?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Malformations
Vascular Malformation Peripheral
Venous Malformation
Vascular Diseases
Keywords: 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
Lead sponsor: University Hospital Erlangen
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Volume Difference of Malformation to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by MRI
timeFrame: one day
measure: Volume Difference of the Affected Extremity to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by Perometre
timeFrame: one day
Secondary outcomes:
measure: 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
timeFrame: up to two months
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital of Erlangen, Vascular Surgery
Study officials:
References: