Randomized controlled trial to assess the volume reduction of the lower leg of subjects with chronic venous insufficiency under two different compression treatments - CLIN-PROT-EU-05-231200

3M Deutschland GmbH0 个研究点目标入组 30 人开始时间: 2015年6月22日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1.Mobile males or females, age 18 years or older
•2.Subjects having a chronic venous insufficiency (stage C3-C5 according to CEAP classification)
•3.Subjects have pitting oedema
•4.Duplex investigation proving superficial or deep obstruction and /or reflux
•5.Subject has good joint mobility allowing exercises requested by the protocol
•6.Subject has an Ankle Brachial Pressure Index ABPI (Ankle Brachial Pressure Index) = 0.8
•7.Willing to give written informed consent and willing to comply with the study protocol

•1.Known pregnancy
•2.Active leg ulcer
•3.Peripheral arterial occlusive disease
•4.Wearing of compression stockings less than 2 days prior to the scheduled study visits
•5.Deep vein thrombosis in the last six months
•6.Active cardiac disease or significant history of cardiac disease,
•7.No change in oedema-reducing therapy (e.g. diuretics) one week before study start
•8.Subjects who were, in the opinion of the investigator, unsuitable for enrolment in this study, for reasons not specified in the exclusion criteria.
•9.Participation in any other prospective clinical study that can potentially interfere with this study

发起方