Validation of a New Method of Limb Volumetry

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

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.

Study Overview

• Status: Unknown
• Conditions: Lymphedema; Edema; Chronic Venous Insufficiency

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.

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• France
  • Herault
    • Montpellier, Herault, France, 34295
      • Recruiting
      • University Hospital Montpellier
      • Contact: SANDRINE MESTRE, MD; Phone Number: 33467337028; Email: s-mestre@chu-montpellier.fr
      • Principal Investigator: Sandrine Mestre, MD
      • Sub-Investigator: Isabelle Quere, MD, PhD
      • Sub-Investigator: Michel Dauzat, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between limb volume measured	Difference between limb volume measured during the same session by water displacement and by 3D laser scanner	36 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: April 6, 2012
• First Submitted That Met QC Criteria: April 9, 2012
• First Posted (Estimate): April 10, 2012

Study Record Updates

• Last Update Posted (Estimate): April 20, 2012
• Last Update Submitted That Met QC Criteria: April 19, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: lymphoedema; volumetry 3D; Displacement of water; Venous chronic insufficiency
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Lymphatic Diseases; Lymphedema; Venous Insufficiency
• Other Study ID Numbers: UF8834