Explorative study on a medical device with two steps. 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.
This diagnostic study will be performed in two steps, in the goal of evaluating a new device, called elastograph. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
130
3 measures by cutometer on each area: the mean value will be the final value
Cutaneous echography on the 3 areas, in order to measure skin thickness and echogenicity Measures are blinded to cutometer (by a different investigator)
10 measures on the 3 areas (central measures will be doubled) Measures will be performed blinded to cutometer
Skin biopsy of 3 mm in diameter, for 30 participants, to evaluate histological fibrosis
University Hospital of Tours
Tours, France
Assessment of dermal/hypodermal fibrosis in lymphedema and venous insuffisency
* Step 1: follow-up of the shear waves spreading, in cutaneous tissues, within 2-3 mm * Step 2: measure of fibrosis of the cutaneous tissue, by transient elastography (elastograph, in kPa)
Time frame: One day
Cutaneous fibrosis measured by cutometer
Cutaneous fibrosis measured by cutometer
Time frame: One day
Cutaneous fibrosis assessed by histology
Cutaneous fibrosis assessed by histology (skin biopsies), using a semi-quantitative scale (0 to 3, from no fibrosis to major fibrosis) Analysis of the samples will be performed altogether at the end of inclusions.
Time frame: 12 months
Cutaneous thickness measured by high resolution ultrasonography
Cutaneous thickness measured by high resolution ultrasonography (in mm)
Time frame: One day
Clinical score of fibrosis
Clinical score of fibrosis, assessed by a scale from 0 (normal skin) to 3 (severe fibrosis): this score is derived from modified Rodnan skin score used in scleroderma
Time frame: One day
Echogenicity of the dermis and superficial hypodermis
Echogenicity of the dermis and superficial hypodermis assessed by high resolution ultrasonography
Time frame: One day
Assessement of adverse events
Assessement of adverse events (pain with a visual analogic scale from 0 to 100, infections of the site of skin biopsies, others)
Time frame: 15 days
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