Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)

Conditions
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Lymphedema, Venous Insufficiency

Intervention / Treatment
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* Device: Cutometer
* Device: High resolution ultrasonography (echography)
* Device: Elastography
* Procedure: Skin biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 groups of subjects<br>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 | Device: Cutometer<br>* 3 measures by cutometer on each area: the mean value will be the final value<br>* Other names: Cutometer MPA 580 (Monaderm);Device: High resolution ultrasonography (echography)<br>* Cutaneous echography on the 3 areas, in order to measure skin thickness and echogenicity Measures are blinded to cutometer (by a different investigator)<br>* Other names: Dermcup (Atys medical);Device: Elastography<br>* 10 measures on the 3 areas (central measures will be doubled) Measures will be performed blinded to cutometer<br>* Other names: high resolution elastography pulse;Procedure: Skin biopsy<br>* Skin biopsy of 3 mm in diameter, for 30 participants, to evaluate histological fibrosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cutaneous fibrosis measured by cutometer | Cutaneous fibrosis measured by cutometer | 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. | 12 months | 
| Cutaneous thickness measured by high resolution ultrasonography | Cutaneous thickness measured by high resolution ultrasonography (in mm) | 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 | One day | 
| Echogenicity of the dermis and superficial hypodermis | Echogenicity of the dermis and superficial hypodermis assessed by high resolution ultrasonography | 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) | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous insufficiency, Lymphedema, Elastograph, Ultrasonography, Fibrosis, Dermis, Hypodermis, Skin