Skip to main content
OpenTrials
Completed

NCT Number: NCT02061254

Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Tours

Tours, 37044, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cutometer

Device

3 measures by cutometer on each area: the mean value will be the final value

Other names: Cutometer MPA 580 (Monaderm)

High resolution ultrasonography (echography)

Device

Cutaneous echography on the 3 areas, in order to measure skin thickness and echogenicity Measures are blinded to cutometer (by a different investigator)

Other names: Dermcup (Atys medical)

Elastography

Device

10 measures on the 3 areas (central measures will be doubled) Measures will be performed blinded to cutometer

Other names: high resolution elastography pulse

skin biopsy

Procedure

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Collaborators

  • Echosens
  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Acronym: TEDECAD

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 12, 2014
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.