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

Varicose Veins of Lower Limb Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05654233
• Other study ID #: ChengduUTCMvs4
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: December 2022
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: Chunshui He, Doctor
• Phone: 18981885601
• Email: chunshuihe[@]msn.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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。

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。

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Varicose Veins
• Varicose Veins of Lower Limb
• Vascular Diseases
• Vascular Diseases, Peripheral
• Venous Insufficiency
• Venous Insufficiency of Leg

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Hospital of Chengdu University of Traditional Chinese Medicine	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in pigmentation area and color depth over the three months after surgery.	Computer software(ImageJ and Brown pixel distribution histogram joint color deconvolution) is used to calculate and record the area of pigmentation and color depth and compare them at different times.	three months
Primary	Changes in the incidence and hardness (Shore hardness) of fibrous induration in the three months after surgery.	The hardness of the fiber induration is calculated and recorded using a Shore hardness tester and compared at different times.The hardness should decrease as the hard knot softens?	three months
Primary	Changes in the area of congestion in the three months after surgery.	Computer software(ImageJ) calculates and records the area of congestion and compares it at different times.	three months
Secondary	Changes in pain scores on a visual analogue scale over the three months postoperatively postoperative	Pain scores are recorded on a Visual Analogue Scale and compared at different times.The scale ranges from 1 to 10, and the higher the score, the more painful it is	three months
Secondary	Incidence of bleeding complications	Regularly review and follow up with patients for the incidence of bleeding complications.(Such as hematemesis, vomiting blood, melena, etc)	three months