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

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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

Tracking Information
First Submitted Date  ICMJE February 10, 2014
First Posted Date  ICMJE February 12, 2014
Last Update Posted Date September 1, 2015
Study Start Date  ICMJE April 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2014)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02061254 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2014)
  • Cutaneous fibrosis measured by cutometer [ Time Frame: One day ]
    Cutaneous fibrosis measured by cutometer
  • 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.
  • Cutaneous thickness measured by high resolution ultrasonography [ Time Frame: One day ]
    Cutaneous thickness measured by high resolution ultrasonography (in mm)
  • 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
  • Echogenicity of the dermis and superficial hypodermis [ Time Frame: One day ]
    Echogenicity of the dermis and superficial hypodermis assessed by high resolution ultrasonography
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)
Official Title  ICMJE Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Venous Insufficiency
  • Lymphedema
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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

Interventions:
  • Device: Cutometer
  • Device: High resolution ultrasonography (echography)
  • Device: Elastography
  • Procedure: Skin biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2015)
130
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2014)
144
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02061254
Other Study ID Numbers  ICMJE PFUI 2013 - AM / TEDECAD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Tours
Study Sponsor  ICMJE University Hospital, Tours
Collaborators  ICMJE
  • Echosens
  • Institut National de la Santé Et de la Recherche Médicale, France
Investigators  ICMJE
Principal Investigator: Annabel MARUANI, MD, PhD CHRU Tours
PRS Account University Hospital, Tours
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP