Influence of Flat-knitted Compression Stockings Class I and II on the Morphology of Venous Malformations - Is There a Therapeutic Effect?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Volume Difference of Malformation to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by MRI
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Volume Difference of Malformation to Baseline (no Compression) While Wearing Compression Stockings Class I and II Determined by MRI
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Dr. med. Antje Mükke
Senior physician Dr. med. Antje Mükke
University Hospital Erlangen