Vascular MalformationsNCT04637997
Influence of Flat-knitted Compression Stockings Class I and II on Venous Malformations
A study testing compression stockings class I and compression stockings class II in people with Vascular Malformations and Vascular Malformation Peripheral, run by University Hospital Erlangen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular Malformations, Vascular Malformation Peripheral, Venous Malformation
- What is being tested?
- compression stockings class I and compression stockings class II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2017to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Occurrence of an emergency situation
- Severe heart failure as contraindication for compression therapy
- Peripheral arterial disease as contraindication for compression therapy
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Erlangen, Vascular Surgery
Erlangen, 91054
About this study
Official title: Influence of Flat-knitted Compression Stockings Class I and II on the Morphology of Venous Malformations - Is There a Therapeutic Effect?
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.
Read more
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
- Being tested
- compression stockings class I, compression stockings class II
- 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
- Medical subject headings
- Vascular Malformations, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compression stockings class IDevice
Daily wearing of compression stockings class I for four weeks on the affected extremity.
compression stockings class IIDevice
Daily wearing of compression stockings class II for four weeks on the affected extremity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: compression stockings class I; Device: compression stockings class II |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: up to two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Oct 2017
- Primary completion1 Mar 2019
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vascular MalformationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Erlangen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Antje Mükke, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637997
- Sponsor's protocol ID
- VM_Compression
- Status last verified
- Mar 2021
- First submitted
- 9 Nov 2020
- Last updated
- 16 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Flat-knitted Compression Stockings Class I and II on the Morphology of Venous Malformations - Is There a Therapeutic Effect?
- ClinicalTrials.gov ID
- NCT04637997
- Acronym / sponsor ID
- VM_Compression
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital ErlangenUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Posted 16 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study group 1 | Other | Device: compression stockings class I, Device: compression stockings class IIWearing 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 | Device: compression stockings class I, Device: compression stockings class IIWearing of compression stockings class II between Investigation day 28 to 56. Wearing of compression stockings class I between Investigation day 56 to 84. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| compression stockings class IDaily wearing of compression stockings class I for four weeks on the affected extremity. | Device | Study group 1, Study group 2 |
| compression stockings class IIDaily wearing of compression stockings class II for four weeks on the affected extremity. | Device | Study group 1, Study group 2 |
Primary outcome
Volume Difference of Malformation to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by MRI
Time frame: 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
Time frame: 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.
1 secondary outcome
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
Time frame: up to two months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing compression stockings class I and compression stockings class II in people with Vascular Malformations and Vascular Malformation Peripheral, run by University Hospital Erlangen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume Difference of Malformation to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by MRI (time frame: one day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.