An observational study in Edema, Chronic Venous Insufficiency and Lymphedema, sponsored by University Hospital, Montpellier. Status unknown at 1 site in France. Open to participants aged 10 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-04-20.
Sponsored by University Hospital, Montpellier · Observational
Volumetry is essential for the diagnosis and follow-up of patients with limb edema. The objective of this project is the validation of real-time reconstruction and calculation of limb volume using a 3D laser scanner.
Water - displacement volumetry (water-filled boot) is the reference method with known accuracy and reproducibility, but is not commonly used in clinical practice because it is cumbersome, difficult, and time-consuming. The most commonly used method remains segmental limb perimetry with a tape measure, followed by volume calculation using the truncated cones formula, thus excluding de facts extremities (hands and feet) which can neither be likened to cones nor easily measured.
Quantification limb volume and volume changes is essential for the diagnosis and follow-up of patients with chronic venous insufficiency or lymphedema, two very common pathological conditions. It is mandatory for the evaluation of therapeutic approaches.
The present study will use an innovative technology of volume acquisition by freehand laser scanning with a hand-held camera with Quantification limb volume and volume changes is essential for the diagnosis and follow-up of patients with chronic venous insufficiency or lymphedema, two very common pathological conditions. It is mandatory for the evaluation of therapeutic approaches.
The present study will use an innovative technology of volume acquisition by freehand laser scanning with a hand-held camera with real-time 3D reconstruction.
Its advantages are non-contact, accurate and detailed quantification of edema, including extremities, allowing to assess the magnitude and topography of physiological, pathological, or treatment - induced volume changes. This approach will ultimately provide data that will used for designing personalized limb compression ortheses.
In each subject and patient, limb volume will be measured once by water - displacement (WD) and twice by 3D laser scanning (3D), by 2 independent operators, in random order. In a subgroup of patients, measurements will be repeated in the morning and evening, twice a year (during winter and during summer) to estimate the nycthemeral and seasonal effects.
Measurements will be performed in healthy subjects and in patients with chronic venous insufficiency or lymphedema.
189 studies on the registry are indexed under Venous Insufficiency; 16 are open to participants now.
This study's planned enrollment of 90 is close to the median of 100 across 41 observational studies indexed under Venous Insufficiency.
Browse Venous Insufficiency studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Recruitment of healthy controls and vascular Medicine clinics for the recruitment of patients with chronic venous insufficiency or lymphedema
Exclusion Criteria:
The objective of this project is the validation of real time reconstruction and calculation of limb volume using a 3 D laser scanner In each subject limb volume will be measured once by water - displacement and twice by 3D laser scanning
The objective of this project is the validation of real time reconstruction and calculation of limb volume using a 3 D laser scanner In each subject limb volume will be measured once by water - displacement and twice by 3D laser scanning
The objective of this project is the validation of real time reconstruction and calculation of limb volume using a 3 D laser scanner In each subject limb volume will be measured once by water - displacement and twice by 3D
Difference between limb volume measured
Difference between limb volume measured during the same session by water displacement and by 3D laser scanner
Time frame: 36 months
This study is status unknown, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier