Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Venous Insufficiency; Lymphedema

Treatments: Device: High resolution ultrasonography (echography); Device: Elastography; Device: Cutometer; Procedure: Skin biopsy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02061254

PFUI 2013 - AM / TEDECAD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

3 groups of subjects

Experimental group

Description:

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

Treatment:

Procedure: Skin biopsy

Device: Cutometer

Device: Elastography

Device: High resolution ultrasonography (echography)