Clinical trial NCT02061254: Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)
Official title: Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Insufficiency
Lymphedema
Keywords: Venous insufficiency
Lymphedema
Elastograph
Ultrasonography
Fibrosis
Dermis
Hypodermis
Skin
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Echosens
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2014-02-12
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of dermal/hypodermal fibrosis in lymphedema and venous insuffisency
timeFrame: One day
Secondary outcomes:
measure: Cutaneous fibrosis measured by cutometer
timeFrame: One day
measure: Cutaneous fibrosis assessed by histology
timeFrame: 12 months
measure: Cutaneous thickness measured by high resolution ultrasonography
timeFrame: One day
measure: Clinical score of fibrosis
timeFrame: One day
measure: Echogenicity of the dermis and superficial hypodermis
timeFrame: One day
measure: Assessement of adverse events
timeFrame: 15 days
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital of Tours
Study officials:
affiliation: CHRU TOURS
name: Annabel MARUANI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: