Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)
NCT ID: NCT02061254
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2014-04-30
2015-06-30
Brief Summary
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The second step will be on 136 participants (48 healthy volunteers, 48 with venous insufficiency and 40 with unilateral lymphedema of a limb). The main objective is to quantify, by high resolution transient elastography, the dermal and hypodermal cutaneous fibrosis in limbs with lymphedema and venous insufficiency, and to compare it to healthy skin.
Detailed Description
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The first pilot step will be on 8 patients (4 with lymphedema and 4 with venous insufficiency). The main objective is to assess the feasibility of measures by high resolution transient elastography on these pathologic skins, and to define 3 areas for measures.
The second step will be on 136 participants (48 healthy volunteers, 48 with venous insufficiency and 40 with unilateral lymphedema of a limb). The main objective is to quantify, by high resolution transient elastography, the dermal and hypodermal cutaneous fibrosis in limbs with lymphedema and venous insufficiency, and to compare it to healthy skin.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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3 groups of subjects
3 groups:
* group of 48 healthy volunteers (matched with venous insufficiency patients)
* group of 48 patients with venous insufficiency (16 with stage 1/2, 16 with stage 3/4, 16 with stage 5/6)
* group of 40 patients with unilateral lymphedema (20 on upper limb (10 early stage, 10 severe stage), and 20 on lower limb (10 early stage, 10 severe stage))
Each group have the same interventions: physical examination, measures by cutometer, high resolution ultrasonography, elastography 30 persons will have a skin biopsy (15 healthy volunteers and 15 patients with venous insufficiency) For patients with lymphedema, all measures will be performed on lymphedema limb and on controlateral healthy limb
Cutometer
3 measures by cutometer on each area: the mean value will be the final value
High resolution ultrasonography (echography)
Cutaneous echography on the 3 areas, in order to measure skin thickness and echogenicity Measures are blinded to cutometer (by a different investigator)
Elastography
10 measures on the 3 areas (central measures will be doubled) Measures will be performed blinded to cutometer
Skin biopsy
Skin biopsy of 3 mm in diameter, for 30 participants, to evaluate histological fibrosis
Interventions
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Cutometer
3 measures by cutometer on each area: the mean value will be the final value
High resolution ultrasonography (echography)
Cutaneous echography on the 3 areas, in order to measure skin thickness and echogenicity Measures are blinded to cutometer (by a different investigator)
Elastography
10 measures on the 3 areas (central measures will be doubled) Measures will be performed blinded to cutometer
Skin biopsy
Skin biopsy of 3 mm in diameter, for 30 participants, to evaluate histological fibrosis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Echosens
INDUSTRY
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Annabel MARUANI, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHRU TOURS
Locations
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University Hospital of Tours
Tours, , France
Countries
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References
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Mofid Y, Faleweei G, Chartier C, Machet L, Vierron E, Gissot V, Tauveront V, Georgescou G, Dujardin PA, Machet MC, Kervarrec T, Patat F, Ossant F, Maruani A. High-Frequency Transient Elastography Prototype to Assess Skin (Dermis) Fibrosis: A Diagnostic Study in Patients with Venous Insufficiency and Controls. Ultraschall Med. 2021 Oct;42(5):503-513. doi: 10.1055/a-1047-3146. Epub 2020 Mar 18.
Related Links
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Clinical Investigation Center - Technological Innovations
Other Identifiers
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PFUI 2013 - AM / TEDECAD
Identifier Type: -
Identifier Source: org_study_id