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 worth discussing in clinical practice. Minimally invasive surgery has become the trend of IPVs' treatment. Currently, sclerotherapy can be performed to treat incompetent perforating veins, which showed a 90% occlusion rate after three or fewer sessions, the recurrence was present nearly 1/3 of cases. While electrocoagulation has a reliable effect on the closure of incompetent perforating veins and simplify treatment. No comparative studies of different PAPS modalities are currently available. Therefore, this study aimed to compare the efficacy of punctured electrocoagulation and sclerotherapy in the treatment of incompetent perforating veins. Methods:This study is a multicenter, randomized controlled trial. We will recruit 84 patients with IPVs from five hospitals. Moreover, these patients will be randomized to either the experimental group (electrocoagulation) or the control group (sclerotherapy). The primary outcome is incompetent perforating veins occlusion rate in the 12th month. Secondary outcomes are quality of life scale survey results (CEAP classification, VCSS score, CIVIQ-14 score), skin ulcer recurrence rate, deep venous Thrombosis, hemorrhage, all-cause mortality, and other vascular events and serious complications.Discussion:This study will provide reliable, evidence-based clinical evidence for the efficacy of electrocoagulation therapy for incompetent perforating veins.

        (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 Criteria:
        (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.