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

NCT07017166 | Completed

• 1 other identifier: S66033-aim5
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Lower Limb Lymphedema

Keywords

Lymphedema; Measurement; Clinical evaluation; Reliability; Validity; Lower limb; Structure sensor scanner

Outcome Measures

Primary Outcomes (3)

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

  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).

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

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

  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.

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

• Clinical feasibility of leg volume measurements using the Structure Sensor Scanner, circumference measurements, and optoelectronic volumetry.

  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.

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

Study Arms (1)

33 patients with LLL

patients with unilateral or bilateral, primary or secundary LLL who visit the center for lymphedema at UZ Leuven

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with unilateral or bilateral, primary or secondary LLL will be recruited at the center for lymphedema in UZ Leuven.

You may qualify if:

• 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

You may not qualify if:

• Pregnant participants
• Presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator

Study Sites (1)

University Hospitals of Leuven, center for lymphedema

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Nele Devoogdt, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 12, 2025
• Study Start: February 20, 2024
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: June 12, 2025

Record last verified: 2025-05

Locations

BE (1)