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

Study Overview
=================
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。

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

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

Intervention / Treatment
-----------------
* Drug: Sulodexide


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A total of 120 patients with varicose veins who received radiofrequency ablation combined with sclerotherapy were randomly divided into two groups。 Each group included 60 people, one group added sulodexide based on the conventional treatment process, and the other group was a control group. The recovery of adverse reactions after surgery in both groups was observed.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Taking sulodexide<br>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。 | Drug: Sulodexide<br>* 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<br>|
| No Intervention: Not taking drug<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiofrequency ablation combined with sclerotherapy, varicose veins, Sulodexide