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

NCT04637997 | Completed Results

• 1 other identifier: VM_Compression
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 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

  up to two months

Study Arms (2)

Study group 1

OTHER

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

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

Study group 2

OTHER

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

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

Interventions

compression stockings class I DEVICE

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

Study group 1; Study group 2

compression stockings class II DEVICE

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

Study group 1; Study group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Erlangen: lead

Study Sites (1)

University Hospital of Erlangen, Vascular Surgery

Erlangen, 91054, Germany

Location

MeSH Terms

Conditions

Vascular Malformations; Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. med. Antje Mükke
• Organization: University Hospital Erlangen, Vascular Surgery

antje.muekke@uk-erlangen.de

+4991318532968

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind study. Neither investigator nor patient knows the compression class (class I versus class II) of the compression stockings used in the different investigation periods in this patient.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician Dr. med. Antje Mükke

Model Details: 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.

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 20, 2020
• Study Start: October 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: October 1, 2020
• Last Updated: March 16, 2021
• Results First Posted: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)