Can shoe insoles help your leg veins? new study says maybe
NCT ID NCT07234240
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 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: * 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.
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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