Pilot study of cyanoacrylate occlusion of the lower limb veins in patients with venous leg ulcers

niversity Hospital of South Manchester0 个研究点目标入组 55 人开始时间: 2018年2月20日最近更新: 2019年4月29日

适应症

试验速览

暂无简介。

•1. Venous ulcer of the lower limb at least 2cm2 (CEAP classification C6)
•2. Ulceration present for >6 weeks and <6months despite treatment
•3. Ipsilateral lower limb vein incompetence of >0.5 seconds duration, confirmed by venous duplex imaging
•4. Aged =18 years
•5. Willing and able to provide informed consent
•6. Ipsilateral ankle-brachial pressure index =0.8 at the time of randomisation

•1. Non-venous cause of ulceration: peripheral arterial disease (ABPI < 0.8), vasculitis, neuropathy, recent lower limb trauma, chronic dermatitis, pyoderma gangrenosum, malignancy, chronic osteomyelitis or any other lower limb pathology that may be contributing to the ulceration, in the opinion of the investigator.
•2. Inability to tolerate or comply with lower limb compression therapy
•3. Inability to receive prompt endovenous treatment
•4. Unwilling or unable to provide informed consent
•5. Current enrolment in another study pertaining to venous ulceration
•6. Primary or secondary immunosuppression
•7. Previous treatment of the target vein or other venous surgery that may compromise the study, in the opinion of the research team
•8. Patient has pre-planned surgical intervention or endovascular procedure scheduled up to 30 days after the index procedure
•9. Currently pregnant
•10. Duplex evidence of deep venous incompetence or occlusion
•11. Clinical evidence of post-thrombotic syndrome
•12. Incompetent vein considered too tortuous to allow VenaSealTM treatment
•13. Inability to tolerate VenaSealTM treatment

发起方

niversity Hospital of South Manchester