An interventional study of treatment: puncture of coagulation and treatment: sclerosing agent injected in Incompetent Perforating Veins, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 5 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
This study aimed to compare the efficacy of punctured electrocoagulation and sclerotherapy in the treatment of incompetent perforator veins.
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.
369 studies on the registry are indexed under Varicose Ulcer; 77 are open to participants now.
This study's planned enrollment of 84 is above the median of 60 across 309 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
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(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 \< 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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the experimental group will receive ultrasound-guided puncture of coagulation incompetent perforator veins.
Procedure: treatment: puncture of coagulation
Participants in the control group will receive an ultrasound-guided sclerosing agent injected.
Procedure: treatment: sclerosing agent injected
ultrasound-guided puncture of coagulation
ultrasound-guided sclerosing agent injected
IPVs occlusion rate in the 12th month.
IPVs occlusion rate is defined as DS \> 50% for each modality with no procedure no procedure performed on the treated segment
Time frame: 12 months after operation
Quality of life scale survey results
quality of life scale survey results (CEAP classification, VCSS score, CIVIQ-14 score).Quality of life will be assessed by MOS item short-form health survey scale (SF-36). SF-36 includes eight subscales: physical functioning (PF, 10 items), role limitations due to physical health problems (RL-P, 4 items), bodily pain (BP, 2 items), general health (GH, 5 items), vitality (V, 4 items), social functioning (SF, 2 items), role limitations due to emotional problems (RL-E, 3 items) and mental health (MH, 5 items). The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).
Time frame: 1-month,6-month,12-month
Skin ulcer recurrence rate
Skin ulcer recurrence
Time frame: 1-month,6-month,12-month
Proportion of participants with deep venous Thrombosis
deep venous Thrombosis
Time frame: 1-month,6-month,12-month
Proportion of participants with hemorrhage
Including hemorrhagic stroke, gastrointestinal bleeding, hematuria, mucocutaneous hemorrhage and other visceral bleeding
Time frame: 1-month,6-month,12-month
All-cause mortality and other vascular events and serious complications.
Percentage of participants with all deaths
Time frame: 1-month,6-month,12-month
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Started Jan 2021 (actual). Primary completion is estimated for Dec 2027, 83 months after the start.
Of 67 non-industry interventional studies with no phase under Varicose Ulcer, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 65. This study's planned 83 months is above that.
Counting every sponsor, half of 133 studies reached it within 28 months; a quarter within 13 and three quarters within 48.
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Second Affiliated Hospital, School of Medicine, Zhejiang University →