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Effect of Short-term Compression Therapy After Thermal Ablation for Varicose Veins

Primary Purpose

Varicose Veins

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
elastic bandage
compression stocking
Sponsored by
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins focused on measuring Varicose veins, Thermal ablation, Compression therapy, Targeted vein occlusion rate, Randomized controlled trial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with primary unilateral lower limb saphenous varicose veins aged 18 to 80 years Patients with CEAP classification of C2-C4 stage 2mm≤diameter of the main trunk of the saphenous vein in the thigh segment ≤15mm Agree to participate in this study and voluntarily sign the informed consent form Exclusion Criteria: Patients who have difficulty tolerating surgery The main trunk of the saphenous vein is extremely twisted or tightly attached to the skin Previous history of ipsilateral varicose vein surgery in the lower extremity Combined deep vein thrombosis in the affected lower extremity or previous deep vein thrombosis in the affected lower extremity Uncorrectable coagulation dysfunction or significant blood abnormalities with significant bleeding tendency (platelets ≤ 30*10^9/L) Acute thrombosis in the saphenous vein Combination of the affected lower extremity lower extremity atherosclerotic occlusive disease who Ankle-brachial index ABI < 0.6 and/or absolute ankle pressure < 60 mmHg Patients who cannot wear elastic stockings or are allergic to elastic bandages or elastic stockings Patients during pregnancy or lactation Previous history of pulmonary embolism Participating in clinical trials of other drugs or devices Other patients deemed unsuitable for this study by the investigator

Sites / Locations

  • The Fourth Affiliated Hospital Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Short-term compression group

Long-term compression group

Arm Description

Patients randomised to group A will be provided with bandages to wear for 48 hours only

Patients randomised to group B will be asked to wear bandages for the first 24h and then a Class 2 compression full-length stocking (23-32mm Hg) for 1 week

Outcomes

Primary Outcome Measures

Target vein occlusion rate as assessed by duplex ultrasound scan
The primary outcome of the study is target vein occlusion rate at 3 months assessed with duplex ultrasound scan. Recanalisation will be defined by a segment of vein≥5cm. Target vein occlusion rate = Number of target venous closure cases in the group/total number of cases in the group

Secondary Outcome Measures

Pain score as assessed by VAS
Patients will be asked to record pain scores with Visual Analogue Score (VAS), The scale ranges from 0 (no pain) to 10 (worst pain imaginable).
Quality of life score as assessed by AVVQ
Patients will be asked to fill the Aberdeen Varicose Veins Questionnaire (AVVQ) to measure health status of varicose vein patients based on symptoms and impact on daily activities. A total score ranging from 0 to 35, with 35 being worst quality of life.
Venous clinical severity score as assessed by VCSS
Patients will be asked to fill the Venous Clinical Severity Score (VCSS) to evaluate the severity of hallmarks of venous disease. The questionnaire consisted of ten questions, each of which was answered by 0 (none), 1 (Mild), 2(Moderate) and 3 (Severe). A total score ranging from 0 to 30, with 30 being worst quality of venous disease.
Postoperative complications
Postoperative complications included postoperative sensory abnormalities, skin burns/discoloration, phlebitis, hematoma, infection, deep vein thrombosis, and pulmonary embolism.
Time to return to normal work
The investigator will use a uniform question to ask the patient how long it takes to return to normal work or life, or both (days).
Compliance
Compliance refers to the extent to which patients followed compression therapy as recommended by their clinicians.Investigators will use a uniform question to ask patients whether they have completed compression treatment as recommended by their doctors in the past week or three months.- 1 (None) , 2 (occasionally) , 3 (mostly) , and 4 (completely) . Those who did not fully follow the study protocol for compression treatment should continue to be asked about their actual compression treatment and recorded.

Full Information

First Posted
April 17, 2023
Last Updated
June 1, 2023
Sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Collaborators
Sir Run Run Shaw Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Wuhan Union Hospital, China, China-Japan Union Hospital, Jilin University, Yantai Yuhuangding Hospital, The First Affiliated Hospital of Dalian Medical University, Affiliated Hospital of Shaoxing University, Jiangsu Province Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05840991
Brief Title
Effect of Short-term Compression Therapy After Thermal Ablation for Varicose Veins
Official Title
Effect of Short-term Compression Therapy After Thermal Ablation for Varicose Veins : a Prospective, Multicenter, Non-inferiority, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Collaborators
Sir Run Run Shaw Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Wuhan Union Hospital, China, China-Japan Union Hospital, Jilin University, Yantai Yuhuangding Hospital, The First Affiliated Hospital of Dalian Medical University, Affiliated Hospital of Shaoxing University, Jiangsu Province Hospital of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A prospective, multicenter, non-inferiority, randomized controlled trial is designed to evaluate the effect after short-term compression therapy following thermal ablation of varicose veins. Patients will be randomly assigned in a 1:1 ratio to one of the following treatments: (A) elastic bandage for 48h or (B) elastic bandage for the first 24h and then a compression full-length stocking (23-32mm Hg) for 1 week. The two groups will be compared on several variables, including target vein occlusion rate at 3 months (primary outcome indicator) , as well as pain, quality of life, clinical severity of varicose veins, postoperative complications, time to return to normal work, and compliance.
Detailed Description
A prospective, multicenter, non-inferiority, randomized controlled trial is designed to evaluate the effect after short-term compression therapy following thermal ablation of varicose veins. Patients will be randomly assigned in a 1:1 ratio to one of the following treatments: (A) elastic bandage for 48h or (B) elastic bandage for the first 24h and then a compression full-length stocking (23-32mm Hg) for 1 week. The two groups will be compared on several variables, including target vein occlusion rate at 3 months (primary outcome indicator) , as well as pain, quality of life, clinical severity of varicose veins, postoperative complications, time to return to normal work, and compliance. The current study will take place in nine hospitals in six provinces in China. Target Population Patients referred to those with primary lower extremity saphenous varicose veins diagnosed in 9 target hospitals from April 2023 to August 2023, and all participants included in the trial signed an informed consent form. Intervention Group A: elastic bandage for 48h Group B: elastic bandage for the first 24h and then a compression full-length stocking (23-32mm Hg) for 1 week Follow-up At baseline, patients will be asked to fill a validated visual analogue scale (VAS) , quality of life questionnaires (AVVQ), and clinical severity of varicose veins (VCSS) . They will also be asked to attend a follow-up in 1 week and at 3 months. At 1 week, target vein closure rate will be examined by double ultrasound scan (DUS) and patients will be asked to fill VAS, AVVQ, VCSS, postoperative complications , time to return to normal work, and compliance. At 3 months, target vein closure rate will be examined by double ultrasound scan (DUS) and patients will be asked to fill VAS, AVVQ, VCSS, postoperative complications , time to return to normal work, and compliance. Sample Size The target vein closure rate in the control group was set to 98%, and α=0.025 (unilateral) and (1-β)=0.9 were taken, combined with clinical expert recommendations, a non-inferiority threshold δ of -6% was taken. We would need to recruit 230 patients (115 per group) to show a difference. However, to increase the robustness of the results, considering a potential lost-to-review rate of 20% of study subjects, combined with the low probability of adverse events in this trial, the total sample size was expanded to 360. Study duration With 3 months follow-up, therefore, the study will be running for 12 months with a target recruitment of 360 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins
Keywords
Varicose veins, Thermal ablation, Compression therapy, Targeted vein occlusion rate, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Short-term compression group
Arm Type
Experimental
Arm Description
Patients randomised to group A will be provided with bandages to wear for 48 hours only
Arm Title
Long-term compression group
Arm Type
Active Comparator
Arm Description
Patients randomised to group B will be asked to wear bandages for the first 24h and then a Class 2 compression full-length stocking (23-32mm Hg) for 1 week
Intervention Type
Device
Intervention Name(s)
elastic bandage
Intervention Description
3M™ Coban™ elastic bandage
Intervention Type
Device
Intervention Name(s)
compression stocking
Intervention Description
Class 2 compression full-length stocking (23-32mm Hg)
Primary Outcome Measure Information:
Title
Target vein occlusion rate as assessed by duplex ultrasound scan
Description
The primary outcome of the study is target vein occlusion rate at 3 months assessed with duplex ultrasound scan. Recanalisation will be defined by a segment of vein≥5cm. Target vein occlusion rate = Number of target venous closure cases in the group/total number of cases in the group
Time Frame
3 months post-op
Secondary Outcome Measure Information:
Title
Pain score as assessed by VAS
Description
Patients will be asked to record pain scores with Visual Analogue Score (VAS), The scale ranges from 0 (no pain) to 10 (worst pain imaginable).
Time Frame
Baseline, 1 week post-op, 3 months post-op
Title
Quality of life score as assessed by AVVQ
Description
Patients will be asked to fill the Aberdeen Varicose Veins Questionnaire (AVVQ) to measure health status of varicose vein patients based on symptoms and impact on daily activities. A total score ranging from 0 to 35, with 35 being worst quality of life.
Time Frame
Baseline, 1 week post-op, 3 months post-op
Title
Venous clinical severity score as assessed by VCSS
Description
Patients will be asked to fill the Venous Clinical Severity Score (VCSS) to evaluate the severity of hallmarks of venous disease. The questionnaire consisted of ten questions, each of which was answered by 0 (none), 1 (Mild), 2(Moderate) and 3 (Severe). A total score ranging from 0 to 30, with 30 being worst quality of venous disease.
Time Frame
Baseline, 1 week post-op, 3 months post-op
Title
Postoperative complications
Description
Postoperative complications included postoperative sensory abnormalities, skin burns/discoloration, phlebitis, hematoma, infection, deep vein thrombosis, and pulmonary embolism.
Time Frame
1 week post-op, 3 months post-op
Title
Time to return to normal work
Description
The investigator will use a uniform question to ask the patient how long it takes to return to normal work or life, or both (days).
Time Frame
1 week post-op, 3 months post-op
Title
Compliance
Description
Compliance refers to the extent to which patients followed compression therapy as recommended by their clinicians.Investigators will use a uniform question to ask patients whether they have completed compression treatment as recommended by their doctors in the past week or three months.- 1 (None) , 2 (occasionally) , 3 (mostly) , and 4 (completely) . Those who did not fully follow the study protocol for compression treatment should continue to be asked about their actual compression treatment and recorded.
Time Frame
1 week post-op, 3 months post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with primary unilateral lower limb saphenous varicose veins aged 18 to 80 years Patients with CEAP classification of C2-C4 stage 2mm≤diameter of the main trunk of the saphenous vein in the thigh segment ≤15mm Agree to participate in this study and voluntarily sign the informed consent form Exclusion Criteria: Patients who have difficulty tolerating surgery The main trunk of the saphenous vein is extremely twisted or tightly attached to the skin Previous history of ipsilateral varicose vein surgery in the lower extremity Combined deep vein thrombosis in the affected lower extremity or previous deep vein thrombosis in the affected lower extremity Uncorrectable coagulation dysfunction or significant blood abnormalities with significant bleeding tendency (platelets ≤ 30*10^9/L) Acute thrombosis in the saphenous vein Combination of the affected lower extremity lower extremity atherosclerotic occlusive disease who Ankle-brachial index ABI < 0.6 and/or absolute ankle pressure < 60 mmHg Patients who cannot wear elastic stockings or are allergic to elastic bandages or elastic stockings Patients during pregnancy or lactation Previous history of pulmonary embolism Participating in clinical trials of other drugs or devices Other patients deemed unsuitable for this study by the investigator
Facility Information:
Facility Name
The Fourth Affiliated Hospital Zhejiang University School of Medicine
City
Yiwu
State/Province
Zhejiang Procince
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuefeng Zhu
Phone
13868101010
Email
srrshzyf@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Short-term Compression Therapy After Thermal Ablation for Varicose Veins

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