N/A
N=18
Influence of Flat-knitted Compression Stockings Class I and II on Venous Malformations
Vascular Malformations · Vascular Malformation Peripheral · Venous Malformation · Vascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT04637997 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Volume Difference of Malformation to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by MRI — 16.38; 23.7 ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- compression stockings class I (Device); compression stockings class II (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University Hospital Erlangen
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Volume Difference of Malformation to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by MRI |
16.38; 23.7 | — |
| PRIMARY Volume Difference of the Affected Extremity to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by Perometre |
124; 90.22 | — |
| 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 |
1.9505; 3.3461; 1.0922; 0.1778; 1.5214; 1.762 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT04637997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.