Validation of a New Method of Limb Volumetry

• Conditions: Edema; Chronic Venous Insufficiency; Lymphedema

• Registration Number: NCT01574911
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Status Verified: 2012-04
• Study Start: 2012-04
• Study First Submitted: 2012-04-06
• Study First Submitted QC: 2012-04-09
• Study First Posted: 2012-04-10
• Last Update Submitted: 2012-04-19
• Last Update Posted: 2012-04-20
• Primary Completion: 2015-06
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference between limb volume measured	36 months	Difference between limb volume measured during the same session by water displacement and by 3D laser scanner

Trial Locations

Locations (1)

University Hospital Montpellier; 🇫🇷 Montpellier, Herault, France