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

NCT05757284 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2024-03-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • Nij Smellinghe Hospital Drachten

    collaborator UNKNOWN

  • KU Leuven

    lead OTHER

Principal Investigators

  • Tessa De Vrieze, Dr. · KU Leuven

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • Belgium
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05757284 on ClinicalTrials.gov