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

Primary Purpose

Venous Insufficiency, Lymphedema

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Cutometer

High resolution ultrasonography (echography)

Elastography

Skin biopsy

About this trial

This is an interventional diagnostic trial for Venous Insufficiency focused on measuring Venous insufficiency, Lymphedema, Elastograph, Ultrasonography, Fibrosis, Dermis, Hypodermis, Skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

University Hospital of Tours

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3 groups of subjects

Arm 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

Outcomes

Primary Outcome Measures

Assessment of dermal/hypodermal fibrosis in lymphedema and venous insuffisency

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

Cutaneous fibrosis measured by cutometer

Cutaneous fibrosis assessed by histology

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

Cutaneous thickness measured by high resolution ultrasonography (in mm)

Clinical score of fibrosis

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

Echogenicity of the dermis and superficial hypodermis assessed by high resolution ultrasonography

Assessement of adverse events

Assessement of adverse events (pain with a visual analogic scale from 0 to 100, infections of the site of skin biopsies, others)

Full Information

NCT ID

NCT02061254

First Posted

February 10, 2014

Last Updated

August 31, 2015

Sponsor

University Hospital, Tours

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02061254

Brief Title

Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)

Acronym

TEDECAD

Official Title

Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

April 2014 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Tours

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Insufficiency, Lymphedema

Keywords

Venous insufficiency, Lymphedema, Elastograph, Ultrasonography, Fibrosis, Dermis, Hypodermis, Skin

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

130 (Actual)

8. Arms, Groups, and Interventions

Arm Title

3 groups of subjects

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Cutometer

Other Intervention Name(s)

Cutometer MPA 580 (Monaderm)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

High resolution ultrasonography (echography)

Other Intervention Name(s)

Dermcup (Atys medical)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Elastography

Other Intervention Name(s)

high resolution elastography pulse

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Skin biopsy

Intervention Description

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

Primary Outcome Measure Information:

Title

Assessment of dermal/hypodermal fibrosis in lymphedema and venous insuffisency

Description

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)

Time Frame

One day

Secondary Outcome Measure Information:

Title

Cutaneous fibrosis measured by cutometer

Description

Cutaneous fibrosis measured by cutometer

Time Frame

One day

Title

Cutaneous fibrosis assessed by histology

Description

Time Frame

12 months

Title

Cutaneous thickness measured by high resolution ultrasonography

Description

Cutaneous thickness measured by high resolution ultrasonography (in mm)

Time Frame

One day

Title

Clinical score of fibrosis

Description

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

Time Frame

One day

Title

Echogenicity of the dermis and superficial hypodermis

Description

Echogenicity of the dermis and superficial hypodermis assessed by high resolution ultrasonography

Time Frame

One day

Title

Assessement of adverse events

Description

Assessement of adverse events (pain with a visual analogic scale from 0 to 100, infections of the site of skin biopsies, others)

Time Frame

15 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Annabel MARUANI, MD, PhD

Organizational Affiliation

CHRU Tours

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Tours

City

Tours

ZIP/Postal Code

37044

Country

France

12. IPD Sharing Statement

Links:

URL

http://cic-it-tours.fr/

Description

Clinical Investigation Center - Technological Innovations

URL

http://www.u930.tours.inserm.fr/equipes/equipe-5-imagerie-et-ultrasons--343959.kjsp?RH=1365087366956&RF=1365085003158

Description

Institut National de la Santé Et de la Recherche Médicale, France; Unit U930; Team 5, which is involved in biomedical applications of ultrasound

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Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)

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