Varicose Veins of Lower LimbNCT05914740
Feasibility Study of Ultrasound-guided Functional Remodeling of Lower Extremity Superficial Venous Valve
A study testing Ultrasound guided functional remodeling of lower extremity superficial vein valve in people with Varicose Veins of Lower Limb, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
In this project, an exploratory study was conducted to perform in situ venous valve remodeling in vivo, evaluate venous valve function after surgery and conduct regular follow-up, collect relevant ultrasonic data before, during and after surgery, and evaluate the safety and effectiveness of Ultrasound-guided… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Varicose Veins of Lower Limb
- What is being tested?
- Ultrasound guided functional remodeling of lower extremity superficial vein valve
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 19 Apr 2023to 30 Jul 2024
- 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
- Age 18-80, gender unlimited
- CEAP grading was C2-C5 patients
- The patient was clinically diagnosed as a primary varicose great saphenous vein of lower extremity, and the ultrasound findings were great saphenous vein valve insufficiency (complete structure, normal shape, enlarged valve ring, Duration of reflux >0.5s), only unilateral varicose great saphenous vein was treated this time
Who cannot join
- Patients with target vessel diameter < 3mm
- The final valve of the great saphenous vein was not clear or lost its normal shape on ultrasound
- Patients with deep vein valvular insufficiency
- The presence of thrombus or thrombophlebitis in the main trunk of great cryptic skin
- Target diseased blood vessel had previously received surgical treatment
- Patients with deep vein thrombosis or history of pulmonary distension embolism
Show all 14Show fewer
- Patients with active implants such as pacemakers or ICDs
- Patients with severe abnormal liver and kidney function (more than three times the normal value)
- Patients with non-primary varicose veins caused by post-deep vein thrombosis syndrome, Cockett syndrome (iliac vein compression syndrome), KT syndrome (venous malformation hypertrophy syndrome >, arteriovenous sputum, etc
- Any serious or uncontrolled systemic disease (including poorly medicated hypertension, diabetes, and diseases with active bleeding signs or severe coagulopathy)
- Patients with diseases that may make treatment and evaluation difficult (e.g., malignant arsine tumor, acute infectious diseases, sepsis, systemic intolerability of surgery, life expectancy less than 12 months, etc.)
- Pregnant and lactating women, or those who planned to have children during the study period
- Patients who have participated in clinical trials of other drugs or medical devices within the last 3 months
- Anesthetist and other patients were deemed unsuitable for the study
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, 322000
Yuefeng Zhu, 13868101010, srrshzyf@zju.edu.cn
About this study
In this project, an exploratory study was conducted to perform in situ venous valve remodeling in vivo, evaluate venous valve function after surgery and conduct regular follow-up, collect relevant ultrasonic data before, during and after surgery, and evaluate the safety and effectiveness of Ultrasound-guided percutaneous great saphenous vein valve functional remodeling.
Read the detailed description
A certain number of patients meeting the requirements (meeting the inclusion criteria, but not meeting the exclusion criteria) were selected for preoperative hemodynamic evaluation of lower extremity vein ultrasound to determine the reflux points and reflux points, identify the blood circulation pattern, and design an individualized surgical program. Intraoperative venous valve was remodeled in situ under ultrasound guidance. Postoperative ultrasound was used to assess venous valve function and complications in the operative area.
Screening period (before surgery 14 days to 0 days) Subject signs informed consent. General information and previous medical history of subjects were collected, preoperative laboratory examination (blood routine, blood biochemistry, coagulation function, preoperative immunity, blood type), electrocardiogram, ultrasound, preoperative hemodynamic evaluation of lower extremity vein were completed, and evaluation scales such as CEAP grading, VCSS, AVVQ, CIVIQ and pain score were completed.
Subjects who meet the inclusion criteria and do not meet all exclusion criteria will be admitted.
Day of surgery (day 0) Preoperative ultrasound was re-evaluated to confirm the valve function, and the tissue was disinfected. Hyaluronic acid was injected around the valve of the great saphenous vein to rebuild the valve about 1-2ml, and the whole process was monitored under ultrasound. During the injection, the valve function was pumped back for protection, and the injection was performed multiple times at different points. Supplementary injection: Following the subject's voluntary principle, the researcher can give supplementary injection after evaluating the general condition of the subject.
The follow-up period for each subject was 12 months ±20 days after enrollment. Follow-up period (±3 days at 1 week, ±5 days at 1 month, ±10 days at 3 months, ±15 days at 6 months, ±20 days at 1 year) General data of subjects were collected, laboratory examination (blood routine and blood biochemistry) and postoperative ultrasound hemodynamic evaluation of lower limb veins were improved, and evaluation scales such as VCSS, AVVQ, CIVIQ and pain score were completed.
This study does not involve vulnerable groups.
- Conditions
- Varicose Veins of Lower Limb
- Being tested
- Ultrasound guided functional remodeling of lower extremity superficial vein valve
- Keywords
- Varicose veins in the lower extremities, Ultrasonic guidance, venous valve of Lower limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided functional remodeling of lower extremity superficial vein valveProcedure or surgery
Preoperative ultrasound was used to re-evaluate and confirm the valve function, disinfect the tissue, inject hyaluronic acid around the great saphenous vein valve to reshape the valve about 1-2ml, monitor the whole process under ultrasound, pump back for protection during injection, and inject multiple times at different points.
| Study group | Role | What they receive |
|---|---|---|
| Venous valve remodeling | Experimental | Venous valve function was remodeled under ultrasound guidance Receives: Procedure: Ultrasound guided functional remodeling of lower extremity superficial vein valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous valve regurgitation or not
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Measured: immediately after intervention
Venous valve regurgitation or not
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Measured: 1 week after intervention
Venous valve regurgitation or not
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Measured: 1 month after intervention
Venous valve regurgitation or not
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Measured: 3 months after intervention
Venous valve regurgitation or not
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Measured: 6 months after intervention
Venous valve regurgitation or not
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Measured: 1 year after intervention
Changes in the duration of venous valve regurgitation
The duration of venous valve regurgitation was measured under calf compression test
Measured: immediately after intervention
Changes in the duration of venous valve regurgitation
The duration of venous valve regurgitation was measured under calf compression test
Measured: 1 week after intervention
Changes in the duration of venous valve regurgitation
The duration of venous valve regurgitation was measured under calf compression test
Measured: 1 month after intervention
Changes in the duration of venous valve regurgitation
The duration of venous valve regurgitation was measured under calf compression test
Measured: 3 months after intervention
Changes in the duration of venous valve regurgitation
The duration of venous valve regurgitation was measured under calf compression test
Measured: 6 months after intervention
Changes in the duration of venous valve regurgitation
The duration of venous valve regurgitation was measured under calf compression test
Measured: 1 year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start19 Apr 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Varicose Veins of Lower LimbStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- A certain number of patients meeting the requirements (meeting the inclusion criteria, but not meeting the exclusion criteria) were selected for preoperative hemodynamic evaluation of lower extremity vein ultrasound to determine the reflux points and reflux points, identify the blood circulation pattern, and design an individualized surgical program. Intraoperative venous valve was reconstructed in situ under ultrasound guidance. Postoperative ultrasound was used to assess venous valve function and complications in the operative area.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuefeng Zhu, Master's, Study director, The Fourth Affiliated Hospital Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914740
- Sponsor's protocol ID
- K2022110
- Status last verified
- Jun 2023
- First submitted
- 24 May 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Maeseneer MG, Kakkos SK, Aherne T, Baekgaard N, Black S, Blomgren L, Giannoukas A, Gohel M, de Graaf R, Hamel-Desnos C, Jawien A, Jaworucka-Kaczorowska A, Lattimer CR, Mosti G, Noppeney T, van Rijn MJ, Stansby G, Esvs Guidelines Committee, Kolh P, Bastos Goncalves F, Chakfe N, Coscas R, de Borst GJ, Dias NV, Hinchliffe RJ, Koncar IB, Lindholt JS, Trimarchi S, Tulamo R, Twine CP, Vermassen F, Wanhainen A, Document Reviewers, Bjorck M, Labropoulos N, Lurie F, Mansilha A, Nyamekye IK, Ramirez Ortega M, Ulloa JH, Urbanek T, van Rij AM, Vuylsteke ME. Editor's Choice - European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs. Eur J Vasc Endovasc Surg. 2022 Feb;63(2):184-267. doi: 10.1016/j.ejvs.2021.12.024. Epub 2022 Jan 11. No abstract available.
PubMed 35027279Muhlberger D, Brenner E, Frings N, Geier B, Mumme A, Reich-Schupke S, Steffen HP, Stenger D, Stucker M, Hummel T. Functional repair of the great saphenous vein by external valvuloplasty reduces the vein's diameter: 6-month results of a multicentre study. J Int Med Res. 2021 May;49(5):3000605211014364. doi: 10.1177/03000605211014364.
PubMed 33990156Zou W, Xu M, Jia Q, Zhu Y. Ultrasound-Guided Extraluminal Venous Valve Functional Remodeling. JACC Case Rep. 2026 Jul 1;31(26):108393. doi: 10.1016/j.jaccas.2026.108393. Epub 2026 May 22.
PubMed 42171574
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Ultrasound-guided Functional Remodeling of Lower Extremity Superficial Venous Valve
- ClinicalTrials.gov ID
- NCT05914740
- Acronym / sponsor ID
- K2022110
- Conditions
- Varicose Veins of Lower Limb
- Keywords
- Varicose veins in the lower extremities, Ultrasonic guidance, venous valve of Lower limb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 22 Jun 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.
In this project, an exploratory study was conducted to perform in situ venous valve remodeling in vivo, evaluate venous valve function after surgery and conduct regular follow-up, collect relevant ultrasonic data before, during and after surgery, and evaluate the safety and effectiveness of Ultrasound-guided percutaneous great saphenous vein valve functional remodeling.
Detailed description
A certain number of patients meeting the requirements (meeting the inclusion criteria, but not meeting the exclusion criteria) were selected for preoperative hemodynamic evaluation of lower extremity vein ultrasound to determine the reflux points and reflux points, identify the blood circulation pattern, and design an individualized surgical program. Intraoperative venous valve was remodeled in situ under ultrasound guidance. Postoperative ultrasound was used to assess venous valve function and complications in the operative area.
Screening period (before surgery 14 days to 0 days) Subject signs informed consent. General information and previous medical history of subjects were collected, preoperative laboratory examination (blood routine, blood biochemistry, coagulation function, preoperative immunity, blood type), electrocardiogram, ultrasound, preoperative hemodynamic evaluation of lower extremity vein were completed, and evaluation scales such as CEAP grading, VCSS, AVVQ, CIVIQ and pain score were completed.
Subjects who meet the inclusion criteria and do not meet all exclusion criteria will be admitted.
Day of surgery (day 0) Preoperative ultrasound was re-evaluated to confirm the valve function, and the tissue was disinfected. Hyaluronic acid was injected around the valve of the great saphenous vein to rebuild the valve about 1-2ml, and the whole process was monitored under ultrasound. During the injection, the valve function was pumped back for protection, and the injection was performed multiple times at different points. Supplementary injection: Following the subject's voluntary principle, the researcher can give supplementary injection after evaluating the general condition of the subject.
The follow-up period for each subject was 12 months ±20 days after enrollment. Follow-up period (±3 days at 1 week, ±5 days at 1 month, ±10 days at 3 months, ±15 days at 6 months, ±20 days at 1 year) General data of subjects were collected, laboratory examination (blood routine and blood biochemistry) and postoperative ultrasound hemodynamic evaluation of lower limb veins were improved, and evaluation scales such as VCSS, AVVQ, CIVIQ and pain score were completed.
This study does not involve vulnerable groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A certain number of patients meeting the requirements (meeting the inclusion criteria, but not meeting the exclusion criteria) were selected for preoperative hemodynamic evaluation of lower extremity vein ultrasound to determine the reflux points and reflux points, identify the blood circulation pattern, and design an individualized surgical program. Intraoperative venous valve was reconstructed in situ under ultrasound guidance. Postoperative ultrasound was used to assess venous valve function and complications in the operative area.
| Arm | Type | Receives |
|---|---|---|
| Venous valve remodeling | Experimental | Procedure: Ultrasound guided functional remodeling of lower extremity superficial vein valveVenous valve function was remodeled under ultrasound guidance |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80, gender unlimited
- CEAP grading was C2-C5 patients
- The patient was clinically diagnosed as a primary varicose great saphenous vein of lower extremity, and the ultrasound findings were great saphenous vein valve insufficiency (complete structure, normal shape, enlarged valve ring, Duration of reflux >0.5s), only unilateral varicose great saphenous vein was treated this time
Key exclusion criteria (14 listed)
- Patients with target vessel diameter < 3mm
- The final valve of the great saphenous vein was not clear or lost its normal shape on ultrasound
- Patients with deep vein valvular insufficiency
- The presence of thrombus or thrombophlebitis in the main trunk of great cryptic skin
- Target diseased blood vessel had previously received surgical treatment
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 |
|---|---|---|
| Ultrasound guided functional remodeling of lower extremity superficial vein valvePreoperative ultrasound was used to re-evaluate and confirm the valve function, disinfect the tissue, inject hyaluronic acid around the great saphenous vein valve to reshape the valve about 1-2ml, monitor the whole process under ultrasound, pump back for protection during injection, and inject multiple times at different points. | Procedure or surgery | Venous valve remodeling |
Primary outcome
Venous valve regurgitation or not
Time frame: immediately after intervention
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Venous valve regurgitation or not
Time frame: 1 week after intervention
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Venous valve regurgitation or not
Time frame: 1 month after intervention
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Venous valve regurgitation or not
Time frame: 3 months after intervention
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Venous valve regurgitation or not
Time frame: 6 months after intervention
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Venous valve regurgitation or not
Time frame: 1 year after intervention
Under the calf compression test, the venous valves were observed for blood flow regurgitation signal
Changes in the duration of venous valve regurgitation
Time frame: immediately after intervention
The duration of venous valve regurgitation was measured under calf compression test
Changes in the duration of venous valve regurgitation
Time frame: 1 week after intervention
The duration of venous valve regurgitation was measured under calf compression test
Changes in the duration of venous valve regurgitation
Time frame: 1 month after intervention
The duration of venous valve regurgitation was measured under calf compression test
Changes in the duration of venous valve regurgitation
Time frame: 3 months after intervention
The duration of venous valve regurgitation was measured under calf compression test
Changes in the duration of venous valve regurgitation
Time frame: 6 months after intervention
The duration of venous valve regurgitation was measured under calf compression test
Changes in the duration of venous valve regurgitation
Time frame: 1 year after intervention
The duration of venous valve regurgitation was measured under calf compression test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Results publication: PubMed 35027279De Maeseneer MG, Kakkos SK, Aherne T, Baekgaard N, Black S, Blomgren L, Giannoukas A, Gohel M, de Graaf R, Hamel-Desnos C, Jawien A, Jaworucka-Kaczorowska A, Lattimer CR, Mosti G, Noppeney T, van Rijn MJ, Stansby G, Esvs Guidelines Committee, Kolh P, Bastos Goncalves F, Chakfe N, Coscas R, de Borst GJ, Dias NV, Hinchliffe RJ, Koncar IB, Lindholt JS, Trimarchi S, Tulamo R, Twine CP, Vermassen F, Wanhainen A, Document Reviewers, Bjorck M, Labropoulos N, Lurie F, Mansilha A, Nyamekye IK, Ramirez Ortega M, Ulloa JH, Urbanek T, van Rij AM, Vuylsteke ME. Editor's Choice - European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs. Eur J Vasc Endovasc Surg. 2022 Feb;63(2):184-267. doi: 10.1016/j.ejvs.2021.12.024. Epub 2022 Jan 11. No abstract available.
- Results publication: PubMed 33990156Muhlberger D, Brenner E, Frings N, Geier B, Mumme A, Reich-Schupke S, Steffen HP, Stenger D, Stucker M, Hummel T. Functional repair of the great saphenous vein by external valvuloplasty reduces the vein's diameter: 6-month results of a multicentre study. J Int Med Res. 2021 May;49(5):3000605211014364. doi: 10.1177/03000605211014364.
- Derived from this study: PubMed 42171574Zou W, Xu M, Jia Q, Zhu Y. Ultrasound-Guided Extraluminal Venous Valve Functional Remodeling. JACC Case Rep. 2026 Jul 1;31(26):108393. doi: 10.1016/j.jaccas.2026.108393. Epub 2026 May 22.
- 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.
Yuefeng Zhu, Master's study director
The Fourth Affiliated Hospital Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided functional remodeling of lower extremity superficial vein valve in people with Varicose Veins of Lower Limb, 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 3 inclusion and 14 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 22 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?
Contact Yuefeng Zhu, Master's (13868101010, zhuyuefeng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous valve regurgitation or not (time frame: immediately after intervention). The study lists 12 primary outcomes in all. 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 NCT05914740, which also lists 3 linked publications.
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 22 Jun 2023.