Venous InsufficiencyTEDECADNCT02061254
Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)
A study testing Cutometer, High resolution ultrasonography (echography) and Elastography in people with Venous Insufficiency and Lymphedema, run by University Hospital, Tours at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Insufficiency, Lymphedema
- What is being tested?
- Cutometer, High resolution ultrasonography (echography) and Elastography
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Cutometer, High resolution ultrasonography (echography), Elastography, Skin biopsy
- Keywords
- Venous insufficiency, Lymphedema, Elastograph, Ultrasonography, Fibrosis, Dermis, Hypodermis, Skin
- Medical subject headings
- Venous Insufficiency, Lymphedema, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CutometerDevice
Also called Cutometer MPA 580 (Monaderm)
3 measures by cutometer on each area: the mean value will be the final value
High resolution ultrasonography (echography)Device
Also called Dermcup (Atys medical)
Cutaneous echography on the 3 areas, in order to measure skin thickness and echogenicity Measures are blinded to cutometer (by a different investigator)
ElastographyDevice
Also called high resolution elastography pulse
10 measures on the 3 areas (central measures will be doubled) Measures will be performed blinded to cutometer
Skin biopsyProcedure or surgery
Skin biopsy of 3 mm in diameter, for 30 participants, to evaluate histological fibrosis
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Cutometer; Device: High resolution ultrasonography (echography); Device: Elastography; Procedure: Skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: One day
Secondary outcomes (6)
Cutaneous fibrosis measured by cutometer
Cutaneous fibrosis measured by cutometer
Measured: One day
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.
Measured: 12 months
Cutaneous thickness measured by high resolution ultrasonography
Cutaneous thickness measured by high resolution ultrasonography (in mm)
Measured: One day
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
Measured: One day
Echogenicity of the dermis and superficial hypodermis
Echogenicity of the dermis and superficial hypodermis assessed by high resolution ultrasonography
Measured: One day
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)
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- Echosens, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Annabel MARUANI, MD, PhD, Principal investigator, CHRU TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061254
- Sponsor's protocol ID
- PFUI 2013 - AM / TEDECAD
- Acronym
- TEDECAD
- Status last verified
- Aug 2015
- First submitted
- 10 Feb 2014
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32187631
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)
- ClinicalTrials.gov ID
- NCT02061254
- Acronym / sponsor ID
- TEDECAD / PFUI 2013 - AM / TEDECAD
- Conditions
- Venous Insufficiency, Lymphedema
- Keywords
- Venous insufficiency, Lymphedema, Elastograph, Ultrasonography, Fibrosis, Dermis, Hypodermis, Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Echosens, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Apr 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3 groups of subjects | Experimental | Device: Cutometer, Device: High resolution ultrasonography (echography), Device: Elastography, Procedure: Skin biopsy3 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients group
- Healthy group
Key exclusion criteria (15 listed)
- Patients group
- Healthy group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CutometerAlso: Cutometer MPA 580 (Monaderm)3 measures by cutometer on each area: the mean value will be the final value | Device | 3 groups of subjects |
| High resolution ultrasonography (echography)Also: Dermcup (Atys medical)Cutaneous echography on the 3 areas, in order to measure skin thickness and echogenicity Measures are blinded to cutometer (by a different investigator) | Device | 3 groups of subjects |
| ElastographyAlso: high resolution elastography pulse10 measures on the 3 areas (central measures will be doubled) Measures will be performed blinded to cutometer | Device | 3 groups of subjects |
| Skin biopsySkin biopsy of 3 mm in diameter, for 30 participants, to evaluate histological fibrosis | Procedure or surgery | 3 groups of subjects |
Primary outcome
Assessment of dermal/hypodermal fibrosis in lymphedema and venous insuffisency
Time frame: One day
* 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)
6 secondary outcomes
Cutaneous fibrosis measured by cutometer
Time frame: One day
Cutaneous fibrosis assessed by histology
Time frame: 12 months
Cutaneous thickness measured by high resolution ultrasonography
Time frame: One day
Clinical score of fibrosis
Time frame: One day
Echogenicity of the dermis and superficial hypodermis
Time frame: One day
Assessement of adverse events
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Results publication: PubMed 32187631Mofid 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.
- Clinical Investigation Center - Technological InnovationsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annabel MARUANI, MD, PhD principal investigator
CHRU TOURS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cutometer, High resolution ultrasonography (echography) and Elastography in people with Venous Insufficiency and Lymphedema, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of dermal/hypodermal fibrosis in lymphedema and venous insuffisency (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02061254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.