Status:
RECRUITING
Percutaneous Electrocoagulation Versus Sclerosing Foam for Patients With Incompetent Perforating Veins
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Sir Run Run Shaw Hospital
Shanghai Zhongshan Hospital
Conditions:
Incompetent Perforating Veins
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study aimed to compare the efficacy of punctured electrocoagulation and sclerotherapy in the treatment of incompetent perforator veins.
Detailed Description
Background: Incompetent perforating vein (IPV) is one of the important causes of persistent venous ulcers of lower extremities and recurrence after operation of varices which is a hot button issue wor...
Eligibility Criteria
Inclusion
- (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
- (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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04686097
Start Date
January 1 2021
End Date
December 30 2025
Last Update
April 18 2024
Active Locations (5)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230000
2
Yantai Yuhuangding Hospital
Yantai, Shandong, China, 264000
3
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200000
4
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310000