A non-interventional study of mediven®- compression stockings on the question of product safety and compliance in patients with phlebological disease in outpatient care according to §23b MPG (German Medical Devices Act) - mediven-RS/2011

medi GmbH & Co. KG0 个研究点目标入组 841 人开始时间: 2014年6月30日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1) Age between 18 and 79 years
•2) CVI stage C1/S – C6 (CEAP)
•3) Phlebological indications according to ICD 10
•4) No phlebological care with compression treatment has been given in the past 6 weeks
•5) 6 weeks has elapsed since a varicosis-eliminating measure on the saphenous veins with 6 weeks of aftercare with MCS (renewed diagnosis of an indication for MCS)
•6) Indication for longer-term (= 18 months) care with round knit MCG is given
•7) No contraindication for MCS
•8) Sufficient mental and physical skills and preconditions for participation in the study
•9) Written declaration of consent is available

•1) Foreseeable life expectancy less than 2 years
•2) Foreseeable need for intervention on the saphenous veins in the coming 18 months
•3) Contraindications for MCS
•4) Lack of sufficient mental and physical skills and preconditions for participation in the study
•5) Need for care with flat knit MCS
•6) Lack of phlebological indications for treatment
•7) Primary lymphoedema; secondary lymphoedema that is not phlebologically-related;
•marked lipoedema
•8) No declaration of consent

发起方

medi GmbH & Co. KG