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Can shoe insoles help your leg veins? new study says maybe

NCT ID NCT07234240

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether special insoles called Light Legs can improve blood flow in the legs (venous return) and quality of life in people with vein problems. Fifty-four adults used the insoles for 14 days and filled out questionnaires about their symptoms and how easy the insoles were to use. The goal was to see if the insoles provided quick relief and made daily life better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
insoles (medical device)
What this could lead to
If effective, these insoles could offer a simple, non-drug way to ease symptoms and improve quality of life for people with venous return problems.
What could go wrong
This is a small, short-term study (54 people, 14 days) with no blinding or placebo control, so results may not be reliable or lasting.

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

54 people

The number who actually took part.

Started

Aug 2025

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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: * Gender: Female/Male; * Age: with 18 years old and older; * Having signed an Informed Consent Form (ICF); * Willingness, ability and likeliness to comply with all the study procedures and restrictions; * Ability to give informed consent; * Available during the entire study period; * Understanding Portuguese language: Portuguese-speaking subjects capable of reading the documents; * Affected by a symptomatic venous return problem; * With a score \>14 from the question 1 to 11 of the adapted CIVIQ questionnaire (each question scored on a scale from 0 to 4); * Agree to wear open shoes suitable for insoles throughout the study, for at least 8 hours per day (with a heel \<5cm); * Having a shoe size of 36 to 41; Exclusion Criteria: * Known allergy or known history of hypersensitivity to the components of the investigational device and related compounds; * Currently participating in another clinical study that may interfere with the study; * Diagnosed skin diseases and/or cutaneous alterations on the test region (feet) that may impair the study (for example tattoos, marks, burns, scars, etc.); * Diagnosed diseases that may impair the study (including but not limited to: Diabetes, Arteritis, Phlebitis, etc); * Under pharmacological treatments on the 30 days previous to the beginning of the study and during the entire period of the study that may impair it (including but not limited to: inflammatory drugs, any drug that might cover the signs and symptoms, drugs with arterial or venous indications, etc.); * Having applied any type of topical product (pharmaceutical, cosmetic or other) with similar effect of the medical device under study, on the test region (feet) during the study, besides the investigational device; * Having a stage of CVD C3 on the CEAP classification; * Having had a traumatic or neurological history in the last 6 months; * Wearing an orthopaedic insole made by a health professional; * Having a significant and disabling lower limb pain; * Having a significant and disabling back pain; * Having a contraindication to wearing insoles and open shoes; * Wearing open shoes with an anatomical shape (e.g. Birkenstock); * Pregnancy or intention to conceive during the study; * Breast-feeding.

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Conditions

The condition(s) this trial relates to.

Signs and Symptoms vein disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Juliana Gouveia

    Porto, Portugal

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