Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 5

This clinical study evaluates the reliability, concurrent validity, and clinical feasibility of a new method to determine leg volume, namely the Structure Sensor Scanner.

The volume of both legs will be determined using three different measurement methods:

1. A scanning method using a Structure Sensor Scanner: for this, both legs are scanned all around with an iPad with the Structure Sensor attached to the tablet. This is performed while standing. The sensor captures depth images, which are then converted into a three-dimensional image of both legs. A computer program is then used to determine the volume of both legs and specific segments of the legs. 2. The circumference measurement using a perimeter: the perimeter consists of a flexible metal strip with a tape measure attached every 4 cm, each ending in a small weight. The person must sit and place only the foot on a small bench so that the entire leg is free. The perimeter is then placed on the leg. Finally, the tape measures are wrapped around the leg, and the circumferences are read. The leg volume is then calculated using the formula of the truncated cone. 3. The optoelectronic volumetry using the Perometer®: for this, the person must stand in shoulder-width stance on the Perometer platform, with one leg inside the frame. The frame is then moved upward. The frame captures silhouettes from which circumference and volumes are calculated through elliptical approximation.

To investigate the reliability, the intra-class correlation coefficient (ICC) is calculated as well as the SEM, SRD and a two-tailed paired samples t-test or a wilcoxon signed rank test (in case of not-normally distributed data). To investigate the concurrent validity of the Structure Sensor Scanner, the results from the scanner method will be compared with those of the two other methods. Regarding the clinical feasibility the duration of each measurement is recorded and a purpose-designed feasibility questionnaire which is completed by the assessors is used.

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Key information

Conditions

Lower Limb Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals of Leuven, center for lymphedema

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Unilateral or bilateral, primary or secondary LLL
Objective diagnosis of lymphedema: ≥ 5% volume difference OR ≥ 2 minor/ 1 major criteria on lymphoscintigraphy OR presence of ICG dermal backflow
Age ≥ 18 years
Able to read, understand and speak Dutch

Exclusion criteria

Pregnant participants
Presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome
Presence of skin infections of wounds at the level of the lower limbs at the moment of inclusion

Treatment and study plan

Primary outcomes

Within-session reliability of leg volume measurements using the Structure Sensor Scanner, circumference measurements, and optoelectronic volumetry.

Time frame: One visit linked to a routine follow-up appointment at the hospital (within-session)

Leg volumes were measured using three methods: the Structure Sensor Scanner device, manual circumference measurements, and optoelectronic volumetry. Intra-rater and inter-rater reliability were assessed through two measurements conducted by assessor A and one by assessor B. Reliability was evaluated using Intraclass Correlation Coefficients (ICC), Standard Error of Measurement (SEM), paired samples t-tests, and Smallest Real Difference (SRD).
Within-session concurrent validity of leg volume measurements using the Structure Sensor Scanner, circumference measurements, and optoelectronic volumetry.

Time frame: One visit linked to a routine follow-up appointment at the hospital (within-session)

Leg volumes were measured using three methods: the Structure Sensor Scanner device, manual circumference measurements, and optoelectronic volumetry. Concurrent validity was assessed through Pearson correlation coefficients between the measurement methods.
Clinical feasibility of leg volume measurements using the Structure Sensor Scanner, circumference measurements, and optoelectronic volumetry.

Time frame: One visit linked to a routine follow-up appointment at the hospital

Leg volumes were measured using three methods: the Structure Sensor Scanner device, manual circumference measurements, and optoelectronic volumetry. Clinical feasibility was determined by recording the duration of each measurement and using a purpose-designed feasibility questionnaire completed by the assessors.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

KU Leuven

Registry information

Official study title

Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema (LLL): To Develop an Evaluation Set for Patients With LLL (AIM 5)

Acronym: EvaLymph-Leg5

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jun 12, 2025
Registry last updated: Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed