Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 4
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 2 clinical evaluations with 1 month in between.
- Who it may be relevant to
- Registry conditions: Lower Limb Lymphedema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Development of an Evaluation Set for Patients With LLL
Overview
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 level of the lower limbs is missing. Information about the clinical relevant change criteria after treatment for nearly all these edema characteristics, is not present and requires investigation. To assess the merits of each treatment in a reproducible manner, a reliable way of measuring limb volume and other edema characteristics must be established, as the evaluation of treatment effects without appropriate tools might lead to biased treatment effects. First of all, in clinical practice, it is of utmost importance to know which edema characteristics need to be evaluated in order to assess the clinical evolution of a patient with lymphedema during and after treatment. Secondly, in order to draw proper conclusions about the treatment effect, it is necessary that to know from which criterion (or cut-off value) one can speak of a real clinical change for a certain lymphedema characteristic. Given that the edema characteristics that are most responsive to treatment and their corresponding criteria for clinically significant and relevant changes at the lower limbs have never been investigated before, the need for this research is high. Therefore, the research questions in this study are: Which measurement tool(s) are able to detect clinically relevant changes in the lymphedema characteristics after the intensive treatment and during the maintenance treatment? When can a clinician speak of a clinically relevant change?
Interventions
- Diagnostic test 2 clinical evaluations with 1 month in between
Patients will be evaluated twice with all evaluation methods selected by the international expert group (cfr. aim 1) showing sufficient reliability and feasibility in the patient group with LLL from aim 1
Primary outcome measures
- Sensitivity of measurement methods [Time frame: 1 month]
- Specificity of measurement methods [Time frame: 1 month]
- Diagnostic accuracy of measurement methods [Time frame: 1 month]
Secondary outcome measures (6)
- Lymphedema volume after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL [Time frame: 1 month]
- Hardness of skin after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL [Time frame: 1 month]
- Piiting status after 4 weeks f intensive DLT in patients with unilateral and bilateral LLL [Time frame: 1 month]
- Skinfold thickness after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL [Time frame: 1 month]
- Extracellullar fluid after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL [Time frame: 1 month]
- Problems in functioning after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL [Time frame: 1 month]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- University Hospitals of Leuven — Leuven
Netherlands · 1 center
- Nij Smellinghe Hospital — Drachten
Identifiers
NCT: NCT06038864 · s66033-aim4