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New questionnaire for leg swelling patients put to the test

NCT ID NCT07075549

Knowledge-focused Sponsor: Universitaire Ziekenhuizen KU Leuven Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at a questionnaire designed to measure how leg swelling (lymphedema) affects daily life. Researchers tested a French version for accuracy and checked if the Dutch version can track changes over time. Over 450 people with leg lymphedema filled out the questionnaire twice. The goal was to make sure the tool works well for French and Dutch speakers.

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.

Participants

451 people

The number who actually took part.

Started

Apr 2025

Finished

Apr 2025

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.

Who is studied

Patients with lower limb lymphedema are treated with decongestive lymphatic therapy and are either in the intensive phase or in the maintenance phase. Patients in both phases are included in this study.

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: * Primary or secondary lymphedema at the lower limb(s), i.e. a difference of ≥5% in volume between the two sides or a lymphoscintigraphy which shows at least 2 minor criteria or 1 major criterion or presence of indocyanine green (ICG) dermal backflow * Unilateral/bilateral lymphedema * Lymphedema stage 1, 2a, 2b or 3 * Lymphedema is present \>3 months * Chemotherapy and radiotherapy was finished \>3 months ago * Native French-speaking or Dutch-speaking for study about the French or Dutch Lymph-ICF-LL, respectively * During the study patients are in the maintenance phase and not in the intensive phase (for the reliability/validity/responsiveness); patients receive intensive treatment in the hospital (for the responsiveness) * Given informed consent to participate * \>18 years old Exclusion Criteria: * Not able to read or fully understand the French or Dutch language for study about the French or Dutch Lymph-ICF-LL, respectively * For the reliability and validity and for part of the responsiveness: first treatment for lymphedema \< 6 months ago and an intensive phase is planned or needed according to a specialized caregiver in treating lymphedema * \<18 years old * Pregnant or breastfeeding women

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Conditions

The condition(s) this trial relates to.

lymphatic malformation 5 lymphedema

As listed by the trial registrant

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

Lymphedema lower extremity

Contacts and locations

Locations

  • CHU UCL Namur site Godinne

    Yvoir, 5332, Belgium

  • Hôpital Cognacq-Jay

    Paris, 75015, France

  • UZ Leuven and KU Leuven

    Leuven, 3000, Belgium

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