Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 3

NCT05757284 | Recruiting

• 1 other identifier: s66033-aim3
• Study Type: observational
• Target: 140
• Locations: 2 countries
• Sites: 2

Brief Summary

The current best practice is a three-stage classification consensus guideline as published by the International Society of Lymphology (ISL). Severity of lymphedema is however not only determined by presence of pitting (which is the phenomenon when the swollen area has a dimple (or pit) after you press it for 5 to 10 seconds) and presence of adipose tissue or not, but is also determined by the volume of the edema, a quantification of the condition of the skin and the location/expansion of the edema over the body. Currently a severity score considering these different aspects does not exist. Although there is consensus that the ISL staging systems is a necessary part of the diagnosis of lymphedema, it gives not enough information about the severity of the lymphedema. A more detailed and comprehensive classification system applicable for primary and secondary lymphedema and considering multiple edema characteristics, remains to be formulated. The researchers objective in this study is to develop a diagnostic set, including a 'severity score', for patients with LLL.

Conditions

Lower Limb Lymphedema

Keywords

severity score; diagnostic set

Outcome Measures

Primary Outcomes (4)

• Sensitivity of measurement methods (resulted from aim 1:NCT05269264) in diagnosing unilateral and bilateral LLL

  all patients with LLL and all healthy controls will be assessed with the selected measurement methods showing sufficient reliability and feasibility in the patient group with LLL from aim 1. Measurement will occur at the genital/midline region, and on both legs/ feet.

  During the recruitment period (up to 1 year), patients are scheduled for only 1 visit with duration of +/- 1 hour (cross-sectional design)

• Specificity of measurement methods (resulted from aim 1:NCT05269264) in diagnosing unilateral and bilateral LLL

  all patients with LLL and all healthy controls will be assessed with the selected measurement methods showing sufficient reliability and feasibility in the patient group with LLL from aim 1. Measurement will occur at the genital/midline region, and on both legs/ feet.

  During the recruitment period (up to 1 year), patients are scheduled for only 1 visit with duration of +/- 1 hour (cross-sectional design)

• Diagnostic accuracy of measurement methods (resulted from aim 1:NCT05269264) in diagnosing unilateral and bilateral LLL

  all patients with LLL and all healthy controls will be assessed with the selected measurement: methods showing sufficient reliability and feasibility in the patient group with LLL from aim 1. Measurement will occur at the genital/midline region, and on both legs/ feet. To determine diagnostic accuracy of the diagnostic methods, in a first phase, data will be analysed using Receiver Operating Characteristic (ROC) curves and by calculation the area under the curve (AUC) for each individual evaluation method resulting from aim 1. Sensitivity and specificity values will be compared, and for each measurement method, the AUC (or C-statistic) will be considered. Also prognostic values and likelihood ratios will be calculated of the individual measurement methods. Lastly, to investigate discriminant validity, measurement outcomes of the patients with LLL will be correlated to the measurement outcomes of the healthy controls.

  During the recruitment period (up to 1 year), patients are scheduled for only 1 visit with duration of +/- 1 hour (cross-sectional design)

• Development of a severity grading score for unilateral and bilateral LLL

  a meeting with the international expert panel will be organized to achieve consensus regarding the measurement methods that should be performed to compile a severity score. Secondly, of all these separate measurement methods, percentiles (20, 40, 60, 80) will be calculated from the data of our study sample for this aim, serving as reference cut-off values. Consequently, 5 'severity' ranges will be presented that will correspond to a severity subscore between 0-5 for each measurement outcome. Lastly, a total severity score will be calculated

  During the recruitment period (up to 1 year), patients are scheduled for only 1 visit with duration of +/- 1 hour (cross-sectional design)

Study Arms (2)

patients with unilateral or bilateral, primary or secundary LLL

Diagnostic Test: Lower Limb Lymhedema assessment

healthy controls

Diagnostic Test: Lower Limb Lymhedema assessment

Interventions

Lower Limb Lymhedema assessment DIAGNOSTIC_TEST

assessessment with the selected measurement methods showing sufficient reliability and feasibility in the patient group with LLL from aim 1:NCT05269264. Measurement will occur at the genital/midline region, and on both legs/ feet.

healthy controls; patients with unilateral or bilateral, primary or secundary LLL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with LLL will be recruited in the center for lymphedema in UH Leuven in Belgium and in the center for lymphedema in Nij Smellinghe Hospital in Drachten in the Netherlands. Healthy volunteers, both in Belgium as well as in the Netherlands.

You may qualify if:

• Patient group
• Unilateral or bilateral, primary or secondary LLL
• Objective diagnosis of lymphedema: ≥ 5% volume difference between both legs OR ≥ 2 minor/ 1 major criteria on lymphoscintigraphy OR presence of ICG dermal backflow
• Age ≥ 18 years
• Able to read, understand and speak Dutch
• Healthy controls
• \- Age, gender \& BMI-matched healthy controls

You may not qualify if:

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

Sponsors & Collaborators

• KU Leuven: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Nij Smellinghe Hospital Drachten: collaborator

Study Sites (2)

University Hospitals of Leuven

Leuven, 3000, Belgium

RECRUITING

Nij Smellinghe Hospital

Drachten, 9202, Netherlands

NOT YET RECRUITING

Study Officials

• Tessa De Vrieze, Dr.

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tessa De Vrieze, Dr.

CONTACT

003216345006; tessa.devrieze@kuleuven.be

Nele Devoogdt, Prof. Dr.

CONTACT

003216342514; nele.devoogdt@kuleuven.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: March 7, 2023
• Study Start: January 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

NL (1); BE (1)