Percutaneous Electrocoagulation Versus Sclerosing Foam for Patients With Incompetent Perforating Veins

NCT04686097 | Recruiting

• 1 other identifier: SAHZhejiangU-003
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Incompetent Perforating Veins

Keywords

Perforating veins; Venous disease; Venous ulcer; Sclerotherapy; Electrocoagulationt

Outcome Measures

Primary Outcomes (1)

• 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

  12 months after operation

Secondary Outcomes (5)

• Quality of life scale survey results

  1-month,6-month,12-month

• Skin ulcer recurrence rate

  1-month,6-month,12-month

• Proportion of participants with deep venous Thrombosis

  1-month,6-month,12-month

• Proportion of participants with hemorrhage

  1-month,6-month,12-month

• All-cause mortality and other vascular events and serious complications.

  1-month,6-month,12-month

Study Arms (2)

experimental group (electrocoagulation)

EXPERIMENTAL

Participants in the experimental group will receive ultrasound-guided puncture of coagulation incompetent perforator veins.

Procedure: treatment: puncture of coagulation

control group (sclerotherapy)

ACTIVE COMPARATOR

Participants in the control group will receive an ultrasound-guided sclerosing agent injected.

Procedure: treatment: sclerosing agent injected

Interventions

treatment: puncture of coagulation PROCEDURE

ultrasound-guided puncture of coagulation

experimental group (electrocoagulation)

treatment: sclerosing agent injected PROCEDURE

ultrasound-guided sclerosing agent injected

control group (sclerotherapy)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Sir Run Run Shaw Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Yantai Yuhuangding Hospital: collaborator
• Anhui Provincial Hospital: collaborator

Study Sites (5)

Anhui Provincial Hospital

Hefei, Anhui, 230000, China

SUSPENDED

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

SUSPENDED

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200000, China

SUSPENDED

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310000, China

SUSPENDED

The second affiliated hospital of zhejiang university school of medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (6)

• Cooper DG, Hillman-Cooper CS, Barker SG, Hollingsworth SJ. Primary varicose veins: the sapheno-femoral junction, distribution of varicosities and patterns of incompetence. Eur J Vasc Endovasc Surg. 2003 Jan;25(1):53-9. doi: 10.1053/ejvs.2002.1782.

  PMID: 12525812 BACKGROUND

• Sakurai T, Matsushita M, Nishikimi N, Nimura Y. Hemodynamic assessment of femoropopliteal venous reflux in patients with primary varicose veins. J Vasc Surg. 1997 Aug;26(2):260-4. doi: 10.1016/s0741-5214(97)70187-3.

  PMID: 9279313 BACKGROUND

• Guex JJ. Ultrasound guided sclerotherapy (USGS) for perforating veins (PV). Hawaii Med J. 2000 Jun;59(6):261-2. No abstract available.

  PMID: 10916243 BACKGROUND

• Masuda EM, Kessler DM, Lurie F, Puggioni A, Kistner RL, Eklof B. The effect of ultrasound-guided sclerotherapy of incompetent perforator veins on venous clinical severity and disability scores. J Vasc Surg. 2006 Mar;43(3):551-6; discussion 556-7. doi: 10.1016/j.jvs.2005.11.038.

  PMID: 16520171 BACKGROUND

• Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079.

  PMID: 21536172 BACKGROUND

• Hager ES, Washington C, Steinmetz A, Wu T, Singh M, Dillavou E. Factors that influence perforator vein closure rates using radiofrequency ablation, laser ablation, or foam sclerotherapy. J Vasc Surg Venous Lymphat Disord. 2016 Jan;4(1):51-6. doi: 10.1016/j.jvsv.2015.08.004.

  PMID: 26946896 BACKGROUND

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zhen jie Liu, MD,PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen jie Liu

CONTACT

86-0571-87913706; lawson4001@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: December 28, 2020
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

CN (5)