Varicose Veins of Lower Limb Clinical Trial
Official title:
The Study of Reducing Adverse Effects After Radiofrequency Ablation Combined With Sclerotherapy
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。
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 |
Country | Name | City | State |
---|---|---|---|
China | Hospital of Chengdu University of Traditional Chinese Medicine | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Chengdu University of Traditional Chinese Medicine |
China,
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 |
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