Short-term compression therapy after thermal ablation for varicose veins

Effect of Short-term Compression Therapy After Thermal Ablation for Varicose Veins : a Prospective, Multicenter, Non-inferiority, Randomized Controlled Trial

This study is testing whether wearing an elastic bandage for 48 hours or a bandage for 24 hours followed by a compression stocking for a week helps people recover better after having thermal ablation for varicose veins.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine (other)
• Locations: 1 site (Yiwu, Zhejiang Procince)
• Trial ID: NCT05840991 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of short-term compression therapy following thermal ablation for varicose veins. Patients will be randomly assigned to receive either an elastic bandage for 48 hours or an elastic bandage for 24 hours followed by a compression stocking for one week. The study aims to compare outcomes such as vein occlusion rates, pain levels, quality of life, and recovery times between the two treatment groups. The trial is being conducted across nine hospitals in six provinces in China.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with primary unilateral lower limb saphenous varicose veins classified as C2-C4.

Not a fit: Patients with severe complications, previous surgeries on the affected limb, or significant blood disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve recovery outcomes and quality of life for patients undergoing treatment for varicose veins.

How similar studies have performed: Previous studies have shown promising results with compression therapy in similar contexts, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Patients with primary unilateral lower limb saphenous varicose veins aged 18 to 80 years
2. Patients with CEAP classification of C2-C4 stage
3. 2mm≤diameter of the main trunk of the saphenous vein in the thigh segment ≤15mm
4. Agree to participate in this study and voluntarily sign the informed consent form

Exclusion Criteria:

1. Patients who have difficulty tolerating surgery
2. The main trunk of the saphenous vein is extremely twisted or tightly attached to the skin
3. Previous history of ipsilateral varicose vein surgery in the lower extremity
4. Combined deep vein thrombosis in the affected lower extremity or previous deep vein thrombosis in the affected lower extremity
5. Uncorrectable coagulation dysfunction or significant blood abnormalities with significant bleeding tendency (platelets ≤ 30\*10\^9/L)
6. Acute thrombosis in the saphenous vein
7. Combination of the affected lower extremity lower extremity atherosclerotic occlusive disease who
8. Ankle-brachial index ABI \< 0.6 and/or absolute ankle pressure \< 60 mmHg
9. Patients who cannot wear elastic stockings or are allergic to elastic bandages or elastic stockings
10. Patients during pregnancy or lactation
11. Previous history of pulmonary embolism
12. Participating in clinical trials of other drugs or devices
13. Other patients deemed unsuitable for this study by the investigator

Where this trial is running

Yiwu, Zhejiang Procince

• The Fourth Affiliated Hospital Zhejiang University School of Medicine — Yiwu, Zhejiang Procince, China (RECRUITING)

Conditions: Varicose Veins, Varicose veins, Thermal ablation, Compression therapy, Targeted vein occlusion rate, Randomized controlled trial