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: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

⁃ 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

Locations
Other Locations
Belgium
University Hospitals of Leuven
RECRUITING
Leuven
Netherlands
Nij Smellinghe Hospital
NOT_YET_RECRUITING
Drachten
Contact Information
Primary
Tessa De Vrieze, Dr.
tessa.devrieze@kuleuven.be
003216345006
Backup
Nele Devoogdt, Prof. Dr.
nele.devoogdt@kuleuven.be
003216342514
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2024-10
Participants
Target number of participants: 140
Treatments
patients with unilateral or bilateral, primary or secundary LLL
healthy controls
Related Therapeutic Areas
Sponsors
Leads: KU Leuven
Collaborators: Universitaire Ziekenhuizen KU Leuven, Nij Smellinghe Hospital Drachten

This content was sourced from clinicaltrials.gov