Vascular Diseases, PeripheralNCT06366763
Comparative Clinical Efficacy Between Multi-layer Bandage Pressure Therapy and Gradient Pressure Elastic Stocking Treatment After Endovenous Radiofrequency Ablation
A study testing Questionnaires in people with Vascular Diseases, Peripheral and Venous Insufficiency of Leg, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Objective: To assess the clinical efficacy of different compression methods within 48 hours after endovenous radiofrequency ablation (RFA) in terms of great saphenous vein closure rate, postoperative complications, quality of life, time to return to normal work, and patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vascular Diseases, Peripheral, Venous Insufficiency of Leg, Varicose Veins of Lower Limb
- What is being tested?
- Questionnaires
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Aug 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 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.
- Color replica ultrasound or venography of the lower extremity veins shows saphenous varicose veins without evidence of deep venous stenosis, filling defects, or ultrasound abnormalities.
- No contraindications to the wearing of compression stockings (e.g., arterial insufficiency, skin allergies)
Who cannot join
- Severe deep vein valve insufficiency or acute deep vein thrombosis of the lower extremities
- Previous history of high ligation and dissection of the saphenous vein, recurrence of collateral branches of the deep vein
- Superficial vein thrombosis is present at the treatment site, with local redness, swelling, warmth, pain, and significant signs of inflammation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610000
Chunshui He, Doctor, 86-18981885601, chunshuihe@msn.com
Qiqi Wangqiqi, Master, 86-15184495605, 285510746@qq.com
About this study
Official title: Comparative Clinical Efficacy Between Multi-layer Bandage Pressure Therapy and Compression Stockings Treatment After Endovenous Radiofrequency Ablation
Objective: To assess the clinical efficacy of different compression methods within 48 hours after endovenous radiofrequency ablation (RFA) in terms of great saphenous vein closure rate, postoperative complications, quality of life, time to return to normal work, and patient satisfaction.
Read the detailed description
Postoperative compression of varicose veins can achieve compression hemostasis, early getting out of bed, reducing edema, preventing phlebitis, ensuring closure effect, reducing soreness and pain, and preventing thrombosis. Compression therapy is a continuation of minimally invasive treatment of varicose veins, and postoperative compression therapy is continued for at least 1 month, and grade II compression therapy may be considered.The application of postoperative compression to the treated limb after radiofrequency ablation of the great saphenous vein has been a topic of controversy. The basic principle of using postoperative compression is to reduce the risk of bleeding, hematoma formation, pain, swelling, and thrombus formation. However, many patients find wearing gradient pressure elastic stockings cumbersome and uncomfortable, as the silicone grips around the stockings can cause skin itching and discomfort. Moreover, there is a lack of strong evidence supporting this treatment. The purpose of this study was to investigate the effectiveness of continuous 48-hour use of gradient pressure elastic stockings for compression of the affected limb after endovenous radiofrequency ablation.
- Being tested
- Questionnaires
- Keywords
- Gradient pressure elastic stockings, Varicose veins, Radiofrequency ablation, Compression therapy
- Medical subject headings
- Peripheral Vascular Diseases, Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesProcedure or surgery
Questionnaires to assess the quality of life (CIVIQ-14 and VCSS scores )
| Study group | Role | What they receive |
|---|---|---|
| gradient pressure elastic stocking treatment after endovenous radiofrequency ablation. | Experimental | Among the 210 patients to assess the clinical efficacy of different compression methods within 48 hours after endovenous radiofrequency ablation (RFA) in terms of great saphenous vein closure rate, postoperative complications, quality of life, time to return to normal work, and patient satisfaction. Receives: Procedure: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain after radiofrequency ablation
Pain is assessed using a visual analogue score (1-10), with higher scores representing more pronounced pain。
Measured: 2 days post-procedure
Bleeding after radiofrequency ablation
Through the observation of ward rounds and telephone follow-up of patients in the hospital, the frequency of postoperative lower limb bleeding events was obtained, with 0 representing no bleeding events and 1 representing bleeding events
Measured: 2 days post-procedure
Tension blisters after radiofrequency ablation
Through the observation of ward rounds and telephone follow-up of patients in the hospital, the frequency of postoperative lower extremity skin tension blister events was obtained, with 0 indicating negative and 1 indicating positive
Measured: 2 days post-procedure
Secondary outcomes (3)
The rate of occlusion of treated vein post-procedure
Use duplex ultrasound assess the occlusion of treated vein post-procedure,record the rate of occlusion of treated vein post-procedure
Measured: 2 days, 1 month, 3 months, 1 year after surgery
Quality of life score using the Chronic Venous Insufficiency Questionnaire(CIVIQ-14)
CIVIQ-14 is a questionnaire based on three dimensions - pain, physical and psychological, based on a scale from 1 to 5 (no trouble, slight, moderate, considerable, severe).Based on inputs, CIVIQ-14 will be tabulated, ranging from 0 to 100 - the higher the value, the poorer the quality of life.In order to observe the changes in quality of life over the whole test procedure.
Measured: 2 days, 1 month, 3 months, 1 year after surgery
Clinical Change using Venous Clinical Severity Score (VCSS)
VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (Mild) , 2(Moderate), 3 (Severe).Record the score separately to observe the changes in quality of life over the whole test procedure.
Measured: 2 days, 1 month, 3 months, 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Aug 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Vascular Diseases, PeripheralStudies of the same condition, open and under way.
- 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
- Among the 210 patients included in the study (82 males, 128 females; average age of 59 years), 7 patients were lost to follow-up, and the remaining patients completed the treatment and follow-up.To assess the clinical efficacy of different compression methods within 48 hours after endovenous radiofrequency ablation (RFA) in terms of great saphenous vein closure rate, postoperative complications, quality of life, time to return to normal work, and patient satisfaction.
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunshui He, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366763
- Sponsor's protocol ID
- ChengduUTCMvs5
- Status last verified
- Apr 2024
- First submitted
- 20 Jan 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Epstein D, Bootun R, Diop M, Ortega-Ortega M, Lane TRA, Davies AH. Cost-effectiveness analysis of current varicose veins treatments. J Vasc Surg Venous Lymphat Disord. 2022 Mar;10(2):504-513.e7. doi: 10.1016/j.jvsv.2021.05.014. Epub 2021 Aug 25.
PubMed 34450353Karathanos C, Spanos K, Batzalexis K, Nana P, Kouvelos G, Rousas N, Giannoukas AD. Prospective comparative study of different endovenous thermal ablation systems for treatment of great saphenous vein reflux. J Vasc Surg Venous Lymphat Disord. 2021 May;9(3):660-668. doi: 10.1016/j.jvsv.2020.10.008. Epub 2020 Oct 21.
PubMed 33099037Siribumrungwong B, Noorit P, Wilasrusmee C, Attia J, Thakkinstian A. A systematic review and meta-analysis of randomised controlled trials comparing endovenous ablation and surgical intervention in patients with varicose vein. Eur J Vasc Endovasc Surg. 2012 Aug;44(2):214-23. doi: 10.1016/j.ejvs.2012.05.017. Epub 2012 Jun 15.
PubMed 22705163Poder TG, Fisette JF, Bedard SK, Despatis MA. Is radiofrequency ablation of varicose veins a valuable option? A systematic review of the literature with a cost analysis. Can J Surg. 2018 Apr;61(2):128-138. doi: 10.1503/cjs.010114.
PubMed 29582749Lawaetz M, Serup J, Lawaetz B, Bjoern L, Blemings A, Eklof B, Rasmussen L. Comparison of endovenous ablation techniques, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Extended 5-year follow-up of a RCT. Int Angiol. 2017 Jun;36(3):281-288. doi: 10.23736/S0392-9590.17.03827-5. Epub 2017 Feb 17.
PubMed 28217989Staubesand J, Seydewitz V. [An ultrastructural study of sclerosed varices]. Phlebologie. 1991 Jan-Mar;44(1):16-22; discussion 33-6. French.
PubMed 1946638Lurie F, Lal BK, Antignani PL, Blebea J, Bush R, Caprini J, Davies A, Forrestal M, Jacobowitz G, Kalodiki E, Killewich L, Lohr J, Ma H, Mosti G, Partsch H, Rooke T, Wakefield T. Compression therapy after invasive treatment of superficial veins of the lower extremities: Clinical practice guidelines of the American Venous Forum, Society for Vascular Surgery, American College of Phlebology, Society for Vascular Medicine, and International Union of Phlebology. J Vasc Surg Venous Lymphat Disord. 2019 Jan;7(1):17-28. doi: 10.1016/j.jvsv.2018.10.002.
PubMed 30554745
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Efficacy Between Multi-layer Bandage Pressure Therapy and Compression Stockings Treatment After Endovenous Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT06366763
- Acronym / sponsor ID
- ChengduUTCMvs5
- Keywords
- Gradient pressure elastic stockings, Varicose veins, Radiofrequency ablation, Compression therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 16 Apr 2024 (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.
Objective: To assess the clinical efficacy of different compression methods within 48 hours after endovenous radiofrequency ablation (RFA) in terms of great saphenous vein closure rate, postoperative complications, quality of life, time to return to normal work, and patient satisfaction.
Detailed description
Postoperative compression of varicose veins can achieve compression hemostasis, early getting out of bed, reducing edema, preventing phlebitis, ensuring closure effect, reducing soreness and pain, and preventing thrombosis. Compression therapy is a continuation of minimally invasive treatment of varicose veins, and postoperative compression therapy is continued for at least 1 month, and grade II compression therapy may be considered.The application of postoperative compression to the treated limb after radiofrequency ablation of the great saphenous vein has been a topic of controversy. The basic principle of using postoperative compression is to reduce the risk of bleeding, hematoma formation, pain, swelling, and thrombus formation. However, many patients find wearing gradient pressure elastic stockings cumbersome and uncomfortable, as the silicone grips around the stockings can cause skin itching and discomfort. Moreover, there is a lack of strong evidence supporting this treatment. The purpose of this study was to investigate the effectiveness of continuous 48-hour use of gradient pressure elastic stockings for compression of the affected limb after endovenous radiofrequency ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Among the 210 patients included in the study (82 males, 128 females; average age of 59 years), 7 patients were lost to follow-up, and the remaining patients completed the treatment and follow-up.To assess the clinical efficacy of different compression methods within 48 hours after endovenous radiofrequency ablation (RFA) in terms of great saphenous vein closure rate, postoperative complications, quality of life, time to return to normal work, and patient satisfaction.
| Arm | Type | Receives |
|---|---|---|
| gradient pressure elastic stocking treatment after endovenous radiofrequency ablation. | Experimental | Procedure: QuestionnairesAmong the 210 patients to assess the clinical efficacy of different compression methods within 48 hours after endovenous radiofrequency ablation (RFA) in terms of great saphenous vein closure rate, postoperative complications, quality of life, time to return to normal work, and patient satisfaction. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- Color replica ultrasound or venography of the lower extremity veins shows saphenous varicose veins without evidence of deep venous stenosis, filling defects, or ultrasound abnormalities.
- No contraindications to the wearing of compression stockings (e.g., arterial insufficiency, skin allergies)
Key exclusion criteria (3 listed)
- Severe deep vein valve insufficiency or acute deep vein thrombosis of the lower extremities
- Previous history of high ligation and dissection of the saphenous vein, recurrence of collateral branches of the deep vein
- Superficial vein thrombosis is present at the treatment site, with local redness, swelling, warmth, pain, and significant signs of inflammation
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 |
|---|---|---|
| QuestionnairesQuestionnaires to assess the quality of life (CIVIQ-14 and VCSS scores ) | Procedure or surgery | gradient pressure elastic stocking treatment after endovenous radiofrequency ablation. |
Primary outcome
Pain after radiofrequency ablation
Time frame: 2 days post-procedure
Pain is assessed using a visual analogue score (1-10), with higher scores representing more pronounced pain。
Bleeding after radiofrequency ablation
Time frame: 2 days post-procedure
Through the observation of ward rounds and telephone follow-up of patients in the hospital, the frequency of postoperative lower limb bleeding events was obtained, with 0 representing no bleeding events and 1 representing bleeding events
Tension blisters after radiofrequency ablation
Time frame: 2 days post-procedure
Through the observation of ward rounds and telephone follow-up of patients in the hospital, the frequency of postoperative lower extremity skin tension blister events was obtained, with 0 indicating negative and 1 indicating positive
3 secondary outcomes
The rate of occlusion of treated vein post-procedure
Time frame: 2 days, 1 month, 3 months, 1 year after surgery
Quality of life score using the Chronic Venous Insufficiency Questionnaire(CIVIQ-14)
Time frame: 2 days, 1 month, 3 months, 1 year after surgery
Clinical Change using Venous Clinical Severity Score (VCSS)
Time frame: 2 days, 1 month, 3 months, 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Results publication: PubMed 34450353Epstein D, Bootun R, Diop M, Ortega-Ortega M, Lane TRA, Davies AH. Cost-effectiveness analysis of current varicose veins treatments. J Vasc Surg Venous Lymphat Disord. 2022 Mar;10(2):504-513.e7. doi: 10.1016/j.jvsv.2021.05.014. Epub 2021 Aug 25.
- Results publication: PubMed 33099037Karathanos C, Spanos K, Batzalexis K, Nana P, Kouvelos G, Rousas N, Giannoukas AD. Prospective comparative study of different endovenous thermal ablation systems for treatment of great saphenous vein reflux. J Vasc Surg Venous Lymphat Disord. 2021 May;9(3):660-668. doi: 10.1016/j.jvsv.2020.10.008. Epub 2020 Oct 21.
- Results publication: PubMed 22705163Siribumrungwong B, Noorit P, Wilasrusmee C, Attia J, Thakkinstian A. A systematic review and meta-analysis of randomised controlled trials comparing endovenous ablation and surgical intervention in patients with varicose vein. Eur J Vasc Endovasc Surg. 2012 Aug;44(2):214-23. doi: 10.1016/j.ejvs.2012.05.017. Epub 2012 Jun 15.
- Results publication: PubMed 29582749Poder TG, Fisette JF, Bedard SK, Despatis MA. Is radiofrequency ablation of varicose veins a valuable option? A systematic review of the literature with a cost analysis. Can J Surg. 2018 Apr;61(2):128-138. doi: 10.1503/cjs.010114.
- Results publication: PubMed 28217989Lawaetz M, Serup J, Lawaetz B, Bjoern L, Blemings A, Eklof B, Rasmussen L. Comparison of endovenous ablation techniques, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Extended 5-year follow-up of a RCT. Int Angiol. 2017 Jun;36(3):281-288. doi: 10.23736/S0392-9590.17.03827-5. Epub 2017 Feb 17.
- Results publication: PubMed 1946638Staubesand J, Seydewitz V. [An ultrastructural study of sclerosed varices]. Phlebologie. 1991 Jan-Mar;44(1):16-22; discussion 33-6. French.
- Results publication: PubMed 30554745Lurie F, Lal BK, Antignani PL, Blebea J, Bush R, Caprini J, Davies A, Forrestal M, Jacobowitz G, Kalodiki E, Killewich L, Lohr J, Ma H, Mosti G, Partsch H, Rooke T, Wakefield T. Compression therapy after invasive treatment of superficial veins of the lower extremities: Clinical practice guidelines of the American Venous Forum, Society for Vascular Surgery, American College of Phlebology, Society for Vascular Medicine, and International Union of Phlebology. J Vasc Surg Venous Lymphat Disord. 2019 Jan;7(1):17-28. doi: 10.1016/j.jvsv.2018.10.002.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires in people with Vascular Diseases, Peripheral and Venous Insufficiency of Leg, run by Chengdu University of Traditional Chinese 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 3 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 16 Apr 2024. 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 Chunshui He, Doctor (18981885601, chunshuihe@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain after radiofrequency ablation (time frame: 2 days post-procedure). The study lists 3 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 NCT06366763, which also lists 7 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 16 Apr 2024.