University Hospital of Tours
Tours, 37044, France
NCT Number: NCT02061254
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Tours, 37044, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3 measures by cutometer on each area: the mean value will be the final value
Other names: Cutometer MPA 580 (Monaderm)
Cutaneous echography on the 3 areas, in order to measure skin thickness and echogenicity Measures are blinded to cutometer (by a different investigator)
Other names: Dermcup (Atys medical)
10 measures on the 3 areas (central measures will be doubled) Measures will be performed blinded to cutometer
Other names: high resolution elastography pulse
Skin biopsy of 3 mm in diameter, for 30 participants, to evaluate histological fibrosis
Time frame: One day
Time frame: One day
Cutaneous fibrosis measured by cutometer
Time frame: 12 months
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.
Time frame: One day
Cutaneous thickness measured by high resolution ultrasonography (in mm)
Time frame: One day
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
Time frame: One day
Echogenicity of the dermis and superficial hypodermis assessed by high resolution ultrasonography
Time frame: 15 days
Assessement of adverse events (pain with a visual analogic scale from 0 to 100, infections of the site of skin biopsies, others)
University Hospital, Tours
Other
Acronym: TEDECAD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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