RecruitingNot ApplicableNCT04686097

Percutaneous Electrocoagulation Versus Sclerosing Foam for Patients With Incompetent Perforating Veins

Percutaneous Electrocoagulation Versus Sclerosing Foam for Patients With Incompetent Perforating Veins : A Multi-center Prospective Randomized Controlled Trial


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

84 participants

Start Date

Jan 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This study aimed to compare the efficacy of punctured electrocoagulation and sclerotherapy in the treatment of incompetent perforator veins.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria1

  • (1) outward flow of less than 500 ms duration, with a diameter of >3.5 mm; (2) According to the CEAP classification method specified by the International Venous Federation, patients with C4b~C6 grades are included.

Exclusion Criteria1

  • (1)age < 18 years or age > 80 years; (2)with malignant tumors and life expectancy < 1 year; (3)with past or current history of deep vein thrombosis and/or pulmonary embolism in the lower extremities; (4)with congenital venous malformations (K-T syndrome, arteriovenous fistula and etc.; (5)inability to walk, long-term braking, restrictive bed rest; severe ischemia of lower extremities or diagnosed severity of peripheral artery occlusive disease; (6)according to the researcher's judgment, it is not suitable for foam hardener and puncture coagulation treatment; (7)allergic to the drugs and equipment materials involved in the research; (8)with inferior vena cava and/or iliac vein stenosis or occlusion; (9)with autoimmune disease, receiving chemotherapy, hormone therapy or immunomodulatory treatment; (10)other underlying severe diseases; women who are pregnant, breastfeeding or have pregnancy plans during the study period; (11)the patient cannot cooperate to complete the inspection and follow-up required by the study.

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Interventions

PROCEDUREtreatment: puncture of coagulation

ultrasound-guided puncture of coagulation

PROCEDUREtreatment: sclerosing agent injected

ultrasound-guided sclerosing agent injected


Locations(5)

Anhui Provincial Hospital

Hefei, Anhui, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

The second affiliated hospital of zhejiang university school of medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT04686097