Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema (LLL): Reliability, Concurrent Validity and Clinical Feasibility of Currently Applied Measurement Tools in Patients With LLL

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ Patient group

• 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

⁃ Healthy controls

⁃ \- Age, gender \& BMI-matched healthy controls

Locations
Other Locations
Belgium
University Hospitals of Leuven, center for lymphedema
RECRUITING
Leuven
Contact Information
Primary
Tessa De Vrieze, Dr.
tessa.devrieze@kuleuven.be
003216345006
Time Frame
Start Date: 2022-02-07
Estimated Completion Date: 2025-10
Participants
Target number of participants: 200
Treatments
patients with unilateral or bilateral, primary or secundary lower limb lymphedema (LLL)
patients with unilateral or bilateral, primary or secundary LLL who visit the center for lymphedema at UH Leuven
healthy controls
age, BMI and gender matched to the patients with LLL
subgroup (n=40)
a subgroup of subjects (patients \& healthy controls) will be evaluated again 2 weeks later
Related Therapeutic Areas
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven
Collaborators: KU Leuven

This content was sourced from clinicaltrials.gov