Actively Recruiting
Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Development of an Evaluation Set for Patients With LLL
Led by KU Leuven · Updated on 2024-09-19
120
Participants Needed
2
Research Sites
39 weeks
Total Duration
On this page
Sponsors
K
KU Leuven
Lead Sponsor
U
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how to best measure changes in swelling and other characteristics of lower limb lymphedema after treatment. This study aims to identify which tools can reliably detect meaningful changes in edema features such as limb volume, skin hardness, and water content during intensive and maintenance treatment phases. Understanding these measurement criteria is important to accurately assess patient progress and treatment effects. Participants include patients with lower limb lymphedema who are either about to start intensive decongestive lymphatic therapy or are in the maintenance phase after completing intensive treatment at least three months prior. Each participant will undergo two clinical evaluations spaced one month apart using a set of reliable and feasible measurement methods selected by experts. These assessments will focus on various edema characteristics to evaluate treatment effects. During the study, participants will be evaluated on limb volume, skin hardness, pitting status, skinfold thickness, extracellular fluid, and functional problems related to lymphedema. The main outcomes measured are the sensitivity, specificity, and diagnostic accuracy of these evaluation methods after one month. This observational study will help establish clear criteria for clinical changes in lower limb lymphedema, supporting better treatment evaluation and patient care.
CONDITIONS
Brief Title
Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 4
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Unilateral or bilateral primary or secondary lower limb lymphedema
- No active metastases
- For cancer-related lymphedema, at least 3 months since surgery, radiotherapy, or chemotherapy
- Objective diagnosis of lymphedema by volume difference, lymphoscintigraphy criteria, or ICG dermal backflow
- Able to read, understand, and speak Dutch
- Planned to start intensive decongestive lymphatic therapy or currently in maintenance therapy for at least 3 months after intensive treatment
You will not qualify if you...
- Pregnant individuals
- Chronic venous insufficiency stages C4, C5, or C6
- Deep venous thrombosis or post-thrombotic syndrome
- Skin infections or wounds on the lower limbs at the time of inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 month
Participants undergo two clinical evaluations using selected diagnostic methods to assess lower limb lymphedema.
2 visits spaced 1 month apart
Duration - 1 month
Participants with lower limb lymphedema are observed for changes in condition during and after intensive or maintenance therapy phases.
Visits coincide with evaluation schedule as applicable
Trial Site Locations
Total: 2 locations
1
University Hospitals of Leuven
Leuven, Belgium, 3000
Actively Recruiting
2
Nij Smellinghe Hospital
Drachten, Netherlands, 9202
Not Yet Recruiting
Research Team
T
Tessa De Vrieze, Dr.
N
Nele Devoogdt, Prof. Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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