The Study of Reducing Adverse Effects After Radiofrequency Ablation Combined With Sclerotherapy

NCT ID: NCT05654233

Last Updated: 2023-01-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-09-01

Brief Summary

The purpose of this study is to evaluate whether adding sulodexide to the patients with varicose veins who received radiofrequency ablation combined with sclerotherapy can reduce or improve the impact of adverse events。

Detailed Description

Chronic venous insufficiency（CVI）of the lower extremities is a commonly clinically syndrome。 It can manifest as telangiectasias (or spider veins), reticular veins, varicose veins（VVS）, edema, pigmentation and/or eczema, liposomal sclerosis, white atrophy, and venous ulcers。 Patients often seek treatment for varicose veins because of cosmetic problems, pain, swelling, itching, ulcers, and other symptoms。 With the development of society, more and more patients require to choose local anesthesia, minimally invasive, and rapid recovery surgery. Radiofrequency ablation(RFA) combined with sclerotherapy is a treatment with a broad clinically applicable spectrum for varicose veins, ranging from the Great saphenous vein （GSV）trunk to telangiectases (or spider veins).US guidelines for treating varicose veins and chronic venous disease of the lower extremities recommend endovascular thermal ablation (including RFA) as safe and effective for treating saphenous venous insufficiency. Foam sclerotherapy is to close the diseased vein by mixing sclerosants with air in a particular proportion and injecting it into the venous blood vessels so that the vein generates artificial thrombus and fibrosis. Because of its simple, economical, and minimally invasive characteristics, it is widely used in clinical practice.

Pigmentation, fibrous induration, and pain are the most common complications after RFA combined with sclerotherapy. Hyperpigmentation is a brownish discoloration of the skin due to extravasation of red blood cells and hemosiderin deposition。 Fibrous induration and pain are mainly caused by thrombosis, inflammation, and vascular fibrosis。 Sulodexide is an orally vasoactive drug consisting of 80% heparin sulfate + 20% corn sulfate， with antithrombotic, fibrinolytic, anti-inflammatory, endothelial protective, and vascular regulating properties. This agent is used in venous ulcers, prevents recurrent venous thromboembolism, and has a low incidence of bleeding complications.

Clinical observation in our department found that adding sulodexide can reduce or improve the impact of adverse events after RFA combined with sclerotherapy。

The purpose of this study is to evaluate whether adding sulodexide to the patients with varicose veins who received RFA combined with sclerotherapy accelerates the dissipation of pigmentation and fibrosis。

Conditions

Vascular Diseases, Peripheral; Venous Insufficiency of Leg; Varicose Veins of Lower Limb

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Taking sulodexide

Sixty patients with varicose veins who received radiofrequency ablation combined with sclerotherapy were given Sulodexide softgels 250LSU twice a day for two months after surgery。

Group Type: EXPERIMENTAL

Sulodexide

Intervention Type: DRUG

The recovery of pigmentation, fibrosis, pain and other indicators in the group taking sulodexide after surgery, one month after surgery and three months after surgery was observed

Not taking drug

Sixty patients with varicose veins of the lower extremities who received radiofrequency ablation combined with sclerotherapy were selected and did not take sulodexide after surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sulodexide

The recovery of pigmentation, fibrosis, pain and other indicators in the group taking sulodexide after surgery, one month after surgery and three months after surgery was observed

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age >18 years and <80 years, and able to understand the requirements of the study and provide informed consent and accept the exams and follow-up.
• C2 - C5 varicose veins / CVI Symptomatic primary GSV, SSV, or AASV incompetence, with reflux >0.5 seconds on color duplex, eligible for patients undergoing radiofrequency ablation plus sclerotherapy
• BMI<35
• The skin color is within the normal range, and no obvious skin color unevenness or skin diseases affect the observed indicators.

Exclusion Criteria

• Acute superficial or deep vein thrombosis
• History of asthma and stroke
• There are skin diseases, scars, infections, and other conditions in the surgical area that affect the observation indicators
• Pregnancy
• Serious damage to liver and kidney function
• Severe obesity (BMI>35) and severe edema of the lower extremities
• Others are not eligible for intravenous radiofrequency ablation combined with sclerotherapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Chunshui He

Director of Vascular Surgery in ChengduUTCM

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China

Countries

China

Central Contacts

Chunshui He, Doctor

Role: CONTACT

chunshuihe@msn.com

18981885601

Facility Contacts

Jiahui Zhou, Master

Role: primary

15517943987@163.com

15517943987

Other Identifiers

ChengduUTCMvs4

Identifier Type: -

Identifier Source: org_study_id