Validation of a New Method of Limb Volumetry
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Purpose
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.
| Condition |
|---|
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Edema Chronic Venous Insufficiency Lymphedema |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| 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 |
- Difference between limb volume measured [ Time Frame: 36 months ] [ Designated as safety issue: No ]Difference between limb volume measured during the same session by water displacement and by 3D laser scanner
Biospecimen Retention: None Retained
Validation study an innovative non-invasive diagnostic technique. Biomedical research conducted with the help of Montpellier University Hospital Clinical Investigation Center (CIC) for the recruitment of healthy controls, and vascular Medicine clinics for the recruitment of patients with chronic venous insufficiency or lymphedema
| Estimated Enrollment: | 90 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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healthy adults
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
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Adults Chronic venous insufficiency
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
|
|
patients primary lymphedema
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
|
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| Ages Eligible for Study: | 10 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Recruitment of healthy controls and vascular Medicine clinics for the recruitment of patients with chronic venous insufficiency or lymphedema
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
Contacts and Locations| Contact: Sandrine MESTRE, MD | 33467337028 | s-mestre@chu-montpellier.fr |
| France | |
| University Hospital Montpellier | Recruiting |
| Montpellier, Herault, France, 34295 | |
| Contact: SANDRINE MESTRE, MD 33467337028 s-mestre@chu-montpellier.fr | |
| Principal Investigator: sandrine Mestre, MD | |
| Sub-Investigator: Isabelle Quere, MD, PhD | |
| Sub-Investigator: Michel Dauzat, MD, PhD | |
More Information
No publications provided
| Responsible Party: | University Hospital, Montpellier |
| ClinicalTrials.gov Identifier: | NCT01574911 History of Changes |
| Other Study ID Numbers: | UF8834 |
| Study First Received: | April 6, 2012 |
| Last Updated: | April 19, 2012 |
| Health Authority: | France: Ministry of Health France: Committee for the Protection of Personnes |
Keywords provided by University Hospital, Montpellier:
|
volumetry 3D Displacement of water lymphoedema Venous chronic insufficiency |
Additional relevant MeSH terms:
|
Edema Lymphedema Venous Insufficiency Signs and Symptoms |
Lymphatic Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 17, 2013