Vascular Diseases, Vascular Malformation Peripheral, Vascular Malformations, Venous Malformation
Conditions
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
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).
Interventions
DEVICEcompression stockings class I
Daily wearing of compression stockings class I for four weeks on the affected extremity.
DEVICEcompression stockings class II
Daily wearing of compression stockings class II for four weeks on the affected extremity.
Sponsors
University Hospital Erlangen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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.
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume Difference of Malformation to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by MRI | one day | 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 | one day | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
Germany
Participant flow
Recruitment details
Participants were informed about the possibility of participating in the study during a routine presentation of the vascular surgery consultation Hours during 01.10.2017-01.12.2018.
Participants by arm
| Arm | Count |
|---|---|
| Study Group 1 Wearing of compression stockings class I between Investigation day 28 to 56. Wearing of compression stockings class II between Investigation day 56 to 84.
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. | 9 |
| Study Group 2 Wearing of compression stockings class II between Investigation day 28 to 56. Wearing of compression stockings class I between Investigation day 56 to 84.
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. | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Total | Study Group 1 | Study Group 2 |
|---|---|---|---|
| Affected part of body arm | 5 Participants | 4 Participants | 1 Participants |
| Affected part of body lower limb | 5 Participants | 3 Participants | 2 Participants |
| Affected part of body upper and lower limb | 2 Participants | 0 Participants | 2 Participants |
| Affected part of body upper limb | 6 Participants | 2 Participants | 4 Participants |
| Age, Continuous | 27.17 years STANDARD_DEVIATION 24.45 | 26.22 years STANDARD_DEVIATION 18.91 | 28.11 years STANDARD_DEVIATION 15.5 |
| Previous therapy | 8 Participants | 5 Participants | 3 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment Germany | 18 participants | 9 participants | 9 participants |
| Sex: Female, Male Female | 12 Participants | 6 Participants | 6 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
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.
Time frame: one day
Population: Intention-to-treat population (ITT): all randomized participants that received flat-knitted compression stockings class I and class II after the randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compression Stockings Class I | Volume Difference of Malformation to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by MRI | 16.38 ml | Standard Deviation 18.28 |
| Compression Stockings Class II | Volume Difference of Malformation to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by MRI | 23.7 ml | Standard Deviation 25.67 |
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.
Time frame: one day
Population: Intention-to-treat population (ITT): all randomized participants that received flat-knitted compression stockings class I and class II after the randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compression Stockings Class I | Volume Difference of the Affected Extremity to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by Perometre | 124 ml | Standard Deviation 351.09 |
| Compression Stockings Class II | Volume Difference of the Affected Extremity to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by Perometre | 90.22 ml | Standard Deviation 226.7 |
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.
Time frame: up to two months
Population: Intention-to-treat population (ITT): all randomized participants that received flat-knitted compression stockings class I and class II after the randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Compression Stockings Class I | 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 | PCS | 1.9505 units on a scale | Standard Deviation 7.2323 |
| Compression Stockings Class I | 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 | MCS | 1.0922 units on a scale | Standard Deviation 9.6244 |
| Compression Stockings Class I | 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 | Overall Health-related Quality of life | 1.5214 units on a scale | Standard Deviation 4.24 |
| Compression Stockings Class II | 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 | PCS | 3.3461 units on a scale | Standard Deviation 7.321 |
| Compression Stockings Class II | 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 | MCS | 0.1778 units on a scale | Standard Deviation 6.865 |
| Compression Stockings Class II | 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 | Overall Health-related Quality of life | 1.762 units on a scale | Standard Deviation 3.164 |