Which works better: electric needle or foam injection for troubled leg veins?

NCT ID NCT04686097

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2021

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

Varicose Ulcer venous insufficiency

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.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Anhui Provincial Hospital

    SUSPENDED

    Hefei, Anhui, 230000, China

  • Sir Run Run Shaw Hospital

    SUSPENDED

    Hangzhou, Zhejiang, 310000, China

  • The second affiliated hospital of zhejiang university school of medicine

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

  • Yantai Yuhuangding Hospital

    SUSPENDED

    Yantai, Shandong, 264000, China

  • Zhongshan Hospital affiliated to Fudan University

    SUSPENDED

    Shanghai, Shanghai Municipality, 200000, China