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

Primary Purpose

Vascular Malformations, Vascular Malformation Peripheral, Venous Malformation

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

compression stockings class I

compression stockings class II

About this trial

This is an interventional treatment trial for Vascular Malformations focused on measuring 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

Eligibility Criteria

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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

Sites / Locations

University Hospital of Erlangen, Vascular Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Study group 1

Study group 2

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04637997

First Posted

November 9, 2020

Last Updated

March 15, 2021

Sponsor

University Hospital Erlangen

1. Study Identification

Unique Protocol Identification Number

NCT04637997

Brief Title

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

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

October 1, 2017 (Actual)

Primary Completion Date

March 1, 2019 (Actual)

Study Completion Date

October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital Erlangen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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.

Masking

ParticipantInvestigator

Masking Description

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.

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study group 1

Arm Type

Other

Arm 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.

Arm Title

Study group 2

Arm Type

Other

Arm 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.

Intervention Type

Device

Intervention Name(s)

compression stockings class I

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

compression stockings class II

Intervention Description

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

Primary Outcome Measure Information:

Title

Volume Difference of Malformation to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by MRI

Description

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.

Time Frame

one day

Title

Volume Difference of the Affected Extremity to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by Perometre

Description

Time Frame

one day

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

up to two months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

University Hospital of Erlangen, Vascular Surgery

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

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

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