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

University Hospital Erlangen

Status: Completed

Conditions: Vascular Malformation Peripheral; Vascular Malformations; Vascular Diseases; Venous Malformation

Treatments: Device: compression stockings class I; Device: compression stockings class II

Study type: Interventional

Funder types: Other

Identifiers

NCT04637997

VM_Compression

Details and patient eligibility

About

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).

Enrollment: 18 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

18 participants in 2 patient groups

Study group 1

Other group

Description:

Wearing of compression stockings class I between Investigation day 28 to 56. Wearing of compression stockings class II between Investigation day 56 to 84.

Treatment:

Device: compression stockings class II

Device: compression stockings class I

Study group 2

Other group

Description:

Wearing of compression stockings class II between Investigation day 28 to 56. Wearing of compression stockings class I between Investigation day 56 to 84.

Treatment:

Device: compression stockings class II

Device: compression stockings class I