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临床试验/NCT05654233
NCT05654233尚未招募不适用

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

Chengdu University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
Changes in pigmentation area and color depth over the three months after surgery.

研究概览

简要总结

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。

详细描述

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。

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • The skin color is within the normal range, and no obvious skin color unevenness or skin diseases affect the observed indicators.

排除标准

  • 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

研究组 & 干预措施

Taking sulodexide

Experimental

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。

干预措施: Sulodexide (Drug)

结局指标

主要结局

Changes in pigmentation area and color depth over the three months after surgery.

时间窗: three months

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.

Changes in the incidence and hardness (Shore hardness) of fibrous induration in the three months after surgery.

时间窗: three months

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。

Changes in the area of congestion in the three months after surgery.

时间窗: three months

Computer software(ImageJ) calculates and records the area of congestion and compares it at different times.

次要结局

  • Changes in pain scores on a visual analogue scale over the three months postoperatively postoperative(three months)
  • Incidence of bleeding complications(three months)

研究者

发起方
Chengdu University of Traditional Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chunshui He

Director of Vascular Surgery in ChengduUTCM

Chengdu University of Traditional Chinese Medicine

研究点 (1)

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