New ultrasound technique measures skin hardening in leg swelling diseases

NCT ID NCT02061254

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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 Results may not be published yet.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

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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This status has not been confirmed recently, so it may be out of date.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 a new ultrasound device to measure skin stiffness (fibrosis) in people with lymphedema or venous insufficiency. Researchers compared results from 130 participants, including healthy volunteers, to see if the device could detect differences in skin hardness. The goal was to understand how these conditions affect the skin, not to provide a treatment.

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

130 people

The number who actually took part.

Start date

Apr 2014

Finished

Jun 2015

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 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Patients group * More than 18 years old * Inform consent form signed * Affiliated to medical insurance * No allergy to local anaesthetic drugs known * For patients with lymphedema of upper limb: unilateral lymphedema occurred after a surgery and/or radiotherapy clinically confirmed by a dermatologist or a physician trained to lymphology, or primitive lymphoedema clinically confirmed by a dermatologist or a physician trained to lymphology, whom the unilateral characteristic will be proved by a recent lymphoscintigraphy (less than 2 years) * For patients with lymphedema of lower limb: unilateral lymphedema occurred after a surgery and/or radiotherapy clinically confirmed by a dermatologist or a physician trained to lymphology, or primitive lymphoedema clinically confirmed by a dermatologist, whom the unilateral characteristic will be proved by a recent lymphoscintigraphy (less than 2 years) * For patients with venous insufficiency without leg ulcer: venous insufficiency without ulcer, clinically diagnosed by a dermatologist or a physician trained to angiology * For patients with venous insufficiency with ulcer: venous insufficiency with ulcer, clinically diagnosed by a dermatologist or a physician trained to angiology * Healthy group * Healthy volunteer * More than 18 years-old * Without any cutaneous pathology on the studied areas * No venous insufficiency ; this will be confirmed by a physician trained to stages of venous insufficiency and will be defined by absence of: edema, varicosities, dilated veins, telangiectasia, venous dermatitis, sclerosis, leg ulcer * Inform consent form signed * Affiliated to medical insurance * No allergy to local anaesthetic drugs known * Matched according to age (± 10 years), gender and weight (± 20 kg) to patients with venous insufficiency Exclusion Criteria: * Patients group * History of aesthetic surgery on studied areas * Cutaneous abnormalities (including scars) on studied areas, except for signs of lymphedema or venous insufficiency * Acute or offset chronic pathology which doesn't allow long-timed explorations (according to investigator's assessment) * Inability to understand information and to sign the consent form (linguistics reasons or neuro-psychological) * Pregnant women, lactating women, and women in age for procreation and without reliable contraception or without history of hysterectomy * Person under guardianship * Healthy group * Haemophilia or equivalent pathology * Cutaneous abnormalities on studied areas (including scars) * History of aesthetic surgery on studied areas * Acute or offset chronic pathology which doesn't allow long-timed explorations (according to investigator's assessment) * Inability to understand information and to sign the consent form (linguistics reasons or neuro-psychological) * Pregnant women, lactating women, and women in age for procreation and without reliable contraception or without antecedent of hysterectomy * Person under guardianship

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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

  • University Hospital of Tours

    Tours, 37044, France

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Other studies related to the condition(s) this trial covers.