NCT05757284

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Lower Limb Lymhedema assessment	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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2023-03-07
• Last updated: 2024-03-12

Locations

2 sites across 2 countries: Belgium, Netherlands