Clinical trial NCT01574911: Validation of a New Method of Limb Volumetry
Official title: Development and Validation of a Limb Volumetry Technique Applicable in Daily Clinical Practice Using Self Positioning 3D Laser Scanning:Reproductibility and Comparison to the Reference Method
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Edema
Chronic Venous Insufficiency
Lymphedema
Keywords: volumetry 3D
Displacement of water
lymphoedema
Venous chronic insufficiency
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 90
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recruitment of healthy controls and vascular Medicine clinics for the recruitment of patients with chronic venous insufficiency or lymphedema

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Either healthy adult or - Adult and chronic venous insufficiency C1s, C3, or C5 (CEAP classification) or - Primary lymphedema (between 10-90 years old)

Exclusion Criteria:

* No consent form

Primary outcomes:
measure: Difference between limb volume measured
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital Montpellier
state: Herault
Study officials:
References: