Which works better: electric needle or foam injection for troubled leg veins?
NCT ID NCT04686097
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This trial compares two minimally invasive procedures for treating incompetent perforating veins—veins that fail to close properly and can cause leg swelling, skin changes, or ulcers. One method uses a needle to deliver an electric current to seal the vein, while the other injects a sclerosing foam to close it. Researchers will measure which approach leads to better vein closure rates and improved quality of life over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- two procedures: ultrasound-guided puncture electrocoagulation and ultrasound-guided sclerosing agent injection
- What this could lead to
- If one method proves superior, it could become the preferred treatment for incompetent perforating veins, improving outcomes and quality of life.
- What could go wrong
- This is a relatively small trial with 84 participants, and results may not apply to all patients. Both procedures carry risks like pain, bruising, or incomplete vein closure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 84 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2021
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: (1) outward flow of less than 500 ms duration, with a diameter of \>3.5 mm; (2) According to the CEAP classification method specified by the International Venous Federation, patients with C4b\~C6 grades are included. Exclusion Criteria: (1)age \< 18 years or age \> 80 years; (2)with malignant tumors and life expectancy \< 1 year; (3)with past or current history of deep vein thrombosis and/or pulmonary embolism in the lower extremities; (4)with congenital venous malformations (K-T syndrome, arteriovenous fistula and etc.; (5)inability to walk, long-term braking, restrictive bed rest; severe ischemia of lower extremities or diagnosed severity of peripheral artery occlusive disease; (6)according to the researcher's judgment, it is not suitable for foam hardener and puncture coagulation treatment; (7)allergic to the drugs and equipment materials involved in the research; (8)with inferior vena cava and/or iliac vein stenosis or occlusion; (9)with autoimmune disease, receiving chemotherapy, hormone therapy or immunomodulatory treatment; (10)other underlying severe diseases; women who are pregnant, breastfeeding or have pregnancy plans during the study period; (11)the patient cannot cooperate to complete the inspection and follow-up required by the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Anhui Provincial Hospital
SUSPENDEDHefei, Anhui, 230000, China
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Sir Run Run Shaw Hospital
SUSPENDEDHangzhou, Zhejiang, 310000, China
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The second affiliated hospital of zhejiang university school of medicine
RECRUITINGHangzhou, Zhejiang, 310000, China
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Yantai Yuhuangding Hospital
SUSPENDEDYantai, Shandong, 264000, China
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Zhongshan Hospital affiliated to Fudan University
SUSPENDEDShanghai, Shanghai Municipality, 200000, China