Varicose VeinsNCT05840991
Effect of Short-term Compression Therapy After Thermal Ablation for Varicose Veins
A study testing elastic bandage and compression stocking in people with Varicose Veins, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Varicose Veins
- What is being tested?
- elastic bandage and compression stocking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Yiwu, Zhejiang Procince, 310000
Yuefeng Zhu, 13868101010, srrshzyf@zju.edu.cn
About this study
Official title: Effect of Short-term Compression Therapy After Thermal Ablation for Varicose Veins : a Prospective, Multicenter, Non-inferiority, Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Varicose Veins
- Being tested
- elastic bandage, compression stocking
- Keywords
- Varicose veins, Thermal ablation, Compression therapy, Targeted vein occlusion rate, Randomized controlled trial
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elastic bandageDevice
3M™ Coban™ elastic bandage
compression stockingDevice
Class 2 compression full-length stocking (23-32mm Hg)
| Study group | Role | What they receive |
|---|---|---|
| Short-term compression group | Experimental | Patients randomised to group A will be provided with bandages to wear for 48 hours only Receives: Device: elastic bandage |
| Long-term compression group | Active comparator | 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 Receives: Device: elastic bandage; Device: compression stocking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months post-op
Secondary outcomes (6)
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).
Measured: Baseline, 1 week post-op, 3 months post-op
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.
Measured: Baseline, 1 week post-op, 3 months post-op
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.
Measured: Baseline, 1 week post-op, 3 months post-op
Postoperative complications
Postoperative complications included postoperative sensory abnormalities, skin burns/discoloration, phlebitis, hematoma, infection, deep vein thrombosis, and pulmonary embolism.
Measured: 1 week post-op, 3 months post-op
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).
Measured: 1 week post-op, 3 months post-op
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.
Measured: 1 week post-op, 3 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start22 May 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840991
- Sponsor's protocol ID
- K2023047
- Status last verified
- Jun 2023
- First submitted
- 17 Apr 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tang M, Jiang W, Hong J, Li L, Shang D, Zhao Y, Liu Z, Qi M, Jin M, Zhu Y. Effect of short-term compression therapy after thermal ablation for varicose veins: study protocol for a prospective, multicenter, non-inferiority, randomized controlled trial. Trials. 2023 Oct 12;24(1):669. doi: 10.1186/s13063-023-07609-1.
PubMed 37828585
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short-term Compression Therapy After Thermal Ablation for Varicose Veins : a Prospective, Multicenter, Non-inferiority, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05840991
- Acronym / sponsor ID
- K2023047
- Conditions
- Varicose Veins
- Keywords
- Varicose veins, Thermal ablation, Compression therapy, Targeted vein occlusion rate, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 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
- Study start
- 22 May 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-term compression group | Experimental | Device: elastic bandagePatients randomised to group A will be provided with bandages to wear for 48 hours only |
| Long-term compression group | Active comparator | Device: elastic bandage, Device: compression stockingPatients 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elastic bandage3M™ Coban™ elastic bandage | Device | Long-term compression group, Short-term compression group |
| compression stockingClass 2 compression full-length stocking (23-32mm Hg) | Device | Long-term compression group |
Primary outcome
Target vein occlusion rate as assessed by duplex ultrasound scan
Time frame: 3 months post-op
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
6 secondary outcomes
Pain score as assessed by VAS
Time frame: Baseline, 1 week post-op, 3 months post-op
Quality of life score as assessed by AVVQ
Time frame: Baseline, 1 week post-op, 3 months post-op
Venous clinical severity score as assessed by VCSS
Time frame: Baseline, 1 week post-op, 3 months post-op
Postoperative complications
Time frame: 1 week post-op, 3 months post-op
Time to return to normal work
Time frame: 1 week post-op, 3 months post-op
Compliance
Time frame: 1 week post-op, 3 months post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Derived from this study: PubMed 37828585Tang M, Jiang W, Hong J, Li L, Shang D, Zhao Y, Liu Z, Qi M, Jin M, Zhu Y. Effect of short-term compression therapy after thermal ablation for varicose veins: study protocol for a prospective, multicenter, non-inferiority, randomized controlled trial. Trials. 2023 Oct 12;24(1):669. doi: 10.1186/s13063-023-07609-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Yiwu, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing elastic bandage and compression stocking in people with Varicose Veins, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target vein occlusion rate as assessed by duplex ultrasound scan (time frame: 3 months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05840991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.