Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)

NCT02061254 | Completed

• 1 other identifier: PFUI 2013 - AM / TEDECAD
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Insufficiency; Lymphedema

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

  One day

Secondary Outcomes (6)

• Cutaneous fibrosis measured by cutometer

  One day

• Cutaneous fibrosis assessed by histology

  12 months

• Cutaneous thickness measured by high resolution ultrasonography

  One day

• Clinical score of fibrosis

  One day

• Echogenicity of the dermis and superficial hypodermis

  One day

Study Arms (1)

3 groups of subjects

EXPERIMENTAL

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; Device: High resolution ultrasonography (echography); Device: Elastography; Procedure: Skin biopsy

Interventions

Elastography DEVICE

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

Also known as: high resolution elastography pulse

3 groups of subjects

Skin biopsy PROCEDURE

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

3 groups of subjects

Cutometer DEVICE

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

Also known as: Cutometer MPA 580 (Monaderm)

3 groups of subjects

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)

Also known as: Dermcup (Atys medical)

3 groups of subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead
• Echosens: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

University Hospital of Tours

Tours, 37044, France

Location

Related Publications (1)

• Mofid Y, Faleweei G, Chartier C, Machet L, Vierron E, Gissot V, Tauveront V, Georgescou G, Dujardin PA, Machet MC, Kervarrec T, Patat F, Ossant F, Maruani A. High-Frequency Transient Elastography Prototype to Assess Skin (Dermis) Fibrosis: A Diagnostic Study in Patients with Venous Insufficiency and Controls. Ultraschall Med. 2021 Oct;42(5):503-513. doi: 10.1055/a-1047-3146. Epub 2020 Mar 18.

  PMID: 32187631 RESULT

Related Links

• Clinical Investigation Center - Technological Innovations

MeSH Terms

Conditions

Venous Insufficiency; Lymphedema; Fibrosis

Interventions

Ultrasonography; Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Annabel MARUANI, MD, PhD

  CHRU TOURS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 12, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 26, 2025

Record last verified: 2015-08

Locations

FR (1)