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

Completed

• Conditions: Lower Limb Lymphedema

• Registration Number: NCT07017166
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-20
• Primary Completion: 2024-03-28
• Study Completion: 2024-03-28
• Status Verified: 2025-05
• Study First Submitted: 2025-06-02
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Within-session concurrent validity of leg volume measurements using the Structure Sensor Scanner, circumference measurements, and optoelectronic volumetry.	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.	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.
Within-session reliability of leg volume measurements using the Structure Sensor Scanner, circumference measurements, and optoelectronic volumetry.	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).

Trial Locations

Locations (1)

University Hospitals of Leuven, center for lymphedema; 🇧🇪 Leuven, Belgium