New ultrasound technique measures skin hardening in leg swelling diseases
NCT ID NCT02061254
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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130 people
The number who actually took part.
- Start date
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Apr 2014
- Finished
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Jun 2015
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * 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
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University Hospital of Tours
Tours, 37044, France
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Other studies related to the condition(s) this trial covers.
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