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

NCT05654233 | Unknown

• 1 other identifier: ChengduUTCMvs4
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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。

Conditions

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

Keywords

Radiofrequency ablation combined with sclerotherapy; varicose veins; Sulodexide

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Changes in pain scores on a visual analogue scale over the three months postoperatively postoperative

  three months

• Incidence of bleeding complications

  three months

Study Arms (2)

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。

Drug: Sulodexide

Not taking drug

NO INTERVENTION

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.

Interventions

Sulodexide 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

Taking sulodexide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Study Sites (1)

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases; Varicose Veins

Interventions

glucuronyl glucosamine glycan sulfate

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Chunshui He, Doctor

CONTACT

18981885601; chunshuihe@msn.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Vascular Surgery in ChengduUTCM

Model Details: 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.

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 16, 2022
• Study Start: February 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: January 3, 2023

Record last verified: 2022-12

Locations

CN (1)