Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02061254
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : September 1, 2015
Sponsor:
Collaborators:
Echosens
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Tours

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.


Condition or disease Intervention/treatment Phase
Venous Insufficiency Lymphedema Device: Cutometer Device: High resolution ultrasonography (echography) Device: Elastography Procedure: Skin biopsy Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)
Study Start Date : April 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
Experimental: 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

Device: Cutometer
3 measures by cutometer on each area: the mean value will be the final value
Other Name: Cutometer MPA 580 (Monaderm)

Device: 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)
Other Name: Dermcup (Atys medical)

Device: Elastography
10 measures on the 3 areas (central measures will be doubled) Measures will be performed blinded to cutometer
Other Name: high resolution elastography pulse

Procedure: Skin biopsy
Skin biopsy of 3 mm in diameter, for 30 participants, to evaluate histological fibrosis




Primary Outcome Measures :
  1. Assessment of dermal/hypodermal fibrosis in lymphedema and venous insuffisency [ Time Frame: One day ]
    • 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)


Secondary Outcome Measures :
  1. Cutaneous fibrosis measured by cutometer [ Time Frame: One day ]
    Cutaneous fibrosis measured by cutometer

  2. Cutaneous fibrosis assessed by histology [ Time Frame: 12 months ]
    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.

  3. Cutaneous thickness measured by high resolution ultrasonography [ Time Frame: One day ]
    Cutaneous thickness measured by high resolution ultrasonography (in mm)

  4. Clinical score of fibrosis [ Time Frame: One day ]
    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

  5. Echogenicity of the dermis and superficial hypodermis [ Time Frame: One day ]
    Echogenicity of the dermis and superficial hypodermis assessed by high resolution ultrasonography

  6. Assessement of adverse events [ Time Frame: 15 days ]
    Assessement of adverse events (pain with a visual analogic scale from 0 to 100, infections of the site of skin biopsies, others)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061254


Locations
Layout table for location information
France
University Hospital of Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
Echosens
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Layout table for investigator information
Principal Investigator: Annabel MARUANI, MD, PhD CHRU Tours

Additional Information:
Layout table for additonal information
Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT02061254     History of Changes
Other Study ID Numbers: PFUI 2013 - AM / TEDECAD
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015

Keywords provided by University Hospital, Tours:
Venous insufficiency
Lymphedema
Elastograph
Ultrasonography
Fibrosis
Dermis
Hypodermis
Skin

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphedema
Venous Insufficiency
Lymphatic Diseases
Vascular Diseases
Cardiovascular Diseases