Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT05269264

Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 1

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03

200

Participants Needed

1

Research Sites

190 weeks

Total Duration

On this page

Sponsors

U

Universitaire Ziekenhuizen KU Leuven

Lead Sponsor

K

KU Leuven

Collaborating Sponsor

AI-Summary

What this Trial Is About

Of all of the different measurement methods that are currently available for use in clinical practice for assessing the same lymphedema characteristic (for example water displacement versus perimetry, both assessing swelling) or different lymphedema characteristics (for example water content in the skin versus hardness of the skin versus thickness of the skin), a clear overview about the reliability, concurrent validity (if applicable) and clinical feasibility is missing for the assessment of lower limb lymphedema (LLL). The objective of this observational cross-sectional study is to investigate the (day-to-day) reliability and clinical feasibility of currently applied measurement tools in patients with LLL.

CONDITIONS

Official Title

Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 1

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Unilateral or bilateral, primary or secondary Lower limb lymphedema (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
  • Age, gender & BMI-matched healthy controls
Not Eligible

You will not qualify if you...

  • Pregnant participants
  • Presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome
  • Presence of skin infections or wounds at the level of the lower limbs at the moment of inclusion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospitals of Leuven, center for lymphedema

Leuven, Belgium, 3000

Actively Recruiting

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Research Team

T

Tessa De Vrieze, Dr.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 1 | DecenTrialz