NCT02061254

Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Venous Insufficiency
• Lymphedema

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-02-12
• Last updated: 2025-12-26

Locations

1 site across 1 country: France