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Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)

NCT02061254 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-12-26

No results posted yet for this study

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

Interventions

DEVICE

Cutometer

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

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)

DEVICE

Elastography

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

PROCEDURE

Skin biopsy

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

Sponsors & Collaborators

  • Echosens

    collaborator INDUSTRY

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

    collaborator OTHER_GOV

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Annabel MARUANI, MD, PhD · CHRU TOURS

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02061254 on ClinicalTrials.gov