Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)

Lymphedema Clinical Trial

— TEDECAD  

Official title:

Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02061254
• Other study ID #: PFUI 2013 - AM / TEDECAD
• Status: Completed
• Phase: N/A
• First received: February 10, 2014
• Last updated: August 31, 2015
• Start date: April 2014
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lymphedema
• Venous Insufficiency

Intervention

Device:
• Cutometer
3 measures by cutometer on each area: the mean value will be the final value
• 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)
• 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

Locations

Country	Name	City	State
France	University Hospital of Tours	Tours

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Tours	Echosens, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Cutaneous fibrosis measured by cutometer	Cutaneous fibrosis measured by cutometer	One day	No
Secondary	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.	12 months	No
Secondary	Cutaneous thickness measured by high resolution ultrasonography	Cutaneous thickness measured by high resolution ultrasonography (in mm)	One day	No
Secondary	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	One day	No
Secondary	Echogenicity of the dermis and superficial hypodermis	Echogenicity of the dermis and superficial hypodermis assessed by high resolution ultrasonography	One day	No
Secondary	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)	15 days	Yes

External Links

•   Clinical Investigation Center - Technological Innovations
•   Institut National de la Santé Et de la Recherche Médicale, France; Unit U930; Team 5, which is involved in biomedical applications of ultrasound