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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| compression stockings class I | Device | Daily wearing of compression stockings class I for four weeks on the affected extremity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Erlangen, Vascular Surgery | Erlangen | 91054 | Germany |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intention-to-treat population (ITT): all randomized participants that received flat-knitted compression stockings class I and class II after the randomization. | Posted | Mean | Standard Deviation | ml | one day |
|
Adverse event data were collected for 18 months during the enrollment, inclusion and investigation period of participants.
During the whole Investigation period there were no participants at Risk for All-Cause Mortality because no potentially life-threatening diagnosis, treatment or therapy was performed. Especially there was no use of drugs, contrast agent or other potentially allergy triggering procedures. All procedures related to the study have been performed non-invasively. Nevertheless, all-cause mortality was monitored.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Compression Stockings Class I | Wearing of compression stockings class I on the effected extremity for four weeks between Investigation day 28 to 56 or between Investigation day 56 to 84. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. med. Antje Mükke | University Hospital Erlangen, Vascular Surgery | +4991318532968 | antje.muekke@uk-erlangen.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2017 | Nov 24, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054079 | Vascular Malformations |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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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.
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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.
| compression stockings class II | Device | Daily wearing of compression stockings class II for four weeks on the affected extremity. |
|
| up to two months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Affected part of body | Count of Participants | Participants |
|
| Previous therapy | Number of participants in whom therapy has already been performed related to the venous malformation. | Count of Participants | Participants |
|
Wearing of compression stockings class II on the affected extremity. |
|
|
| 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. | Intention-to-treat population (ITT): all randomized participants that received flat-knitted compression stockings class I and class II after the randomization. | Posted | Mean | Standard Deviation | ml | one day |
|
|
|
| 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. | Intention-to-treat population (ITT): all randomized participants that received flat-knitted compression stockings class I and class II after the randomization. | Posted | Mean | Standard Deviation | units on a scale | up to two months |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Compression Stockings Class II | Wearing of compression stockings class II on the effected extremity for four weeks between Investigation day 28 to 56 or between Investigation day 56 to 84. | 0 | 18 | 0 | 18 | 0 | 18 |
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| Overall Health-related Quality of life |
|