Status:
RECRUITING
Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 4
Lead Sponsor:
KU Leuven
Collaborating Sponsors:
Universitaire Ziekenhuizen KU Leuven
Nij Smellinghe Hospital Drachten
Conditions:
Lower Limb Lymphedema
Eligibility:
All Genders
18+ years
Brief Summary
Research investigating measurement properties for evaluating the decongestive treatment effect on different edema characteristics (e.g. water volume, hardness of the skin, water content,..) at the lev...
Eligibility Criteria
Inclusion
- Intensive treatment group
- Unilateral or bilateral, primary or secondary LLL
- No active metastases
- If cancer-related lymphedema, time interval since surgery/ radiotherapy/ chemotherapy is ≥3 months
- Objective diagnosis of lymphedema: ≥ 5% volume difference OR ≥ 2 minor/ 1 major criteria on lymphoscintigraphy OR presence of ICG dermal backflow
- Age ≥ 18 years
- Able to read, understand and speak Dutch
- Planned to start with intensive decongestive lymphatic therapy at one or both legs
- Maintenance treatment group
- See inclusion criteria 'intensive treatment group'
- But: instead of patients planned to start with intensive lymphatic therapy, patients of this group should have ended their intensive treatment phase at least 3 months ago (= currently receiving maintenance decongestive lymphatic therapy)
Exclusion
- Pregnant participants
- Presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome
- Presence of skin infections of wounds at the level of the lower limbs at the moment of inclusion
Key Trial Info
Start Date :
April 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06038864
Start Date
April 1 2024
End Date
December 1 2025
Last Update
September 19 2024
Active Locations (2)
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1
University Hospitals of Leuven
Leuven, Belgium, 3000
2
Nij Smellinghe Hospital
Drachten, Netherlands, 9202