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?
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
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
Intensive treatment group: Patients planned to start with intensive decongestive lymphatic therapy at one or both legs. Maintenance treatment group: patienst who have ended their intensive treatment phase at least 3 months ago (= currently receiving maintenance decongestive lymphatic therapy)
Cohort
Prospective
2 clinical evaluations with 1 month in between
Diagnostic testPatients 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
Sensitivity of measurement methods
Sensitivity of measurement methods (resulting from aim 1:NCT05269264) in the evaluation of the treatment effect over time in patients with unilateral and bilateral LLL. Patients will be evaluated twice with 1 month in between.
Specificity of measurement methods
Specificity of measurement methods (resulting from aim 1:NCT05269264) in the evaluation of the treatment effect over time in patients with unilateral and bilateral LLL. Patients will be evaluated twice with 1 month in between.
Diagnostic accuracy of measurement methods
Diagnostic accuracy (in terms of area under the curve using a ROC curve, as well as sensitivity and specificity) of measurement methods (resulting from aim 1:NCT05269264) in the evaluation of the treatment effect over time in patients with unilateral and bilateral LLL. Patients will be evaluated twice with 1 month in between.
Lymphedema volume after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL
Evaluation of different outcome parameters in the patients from the 'intensive group' with unilateral LLL and patients with bilateral LLL: Lymphedema volume (foot, leg)
Hardness of skin after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL
Evaluation of different outcome parameters in the patients from the 'intensive group' with unilateral LLL and patients with bilateral LLL: skin hardness test at the level of the foot, leg and midline region. Skin is palpated with thumb and index (and, if possible, compared to the contralateral side) Outcome: If skin is hardened; yes(1), otherwise; no(0)
Piiting status after 4 weeks f intensive DLT in patients with unilateral and bilateral LLL
Evaluation of different outcome parameters in the patients from the 'intensive group' with unilateral LLL and patients with bilateral LLL: Pitting test at the level of the foot, leg and midline region; The grading of edema is determined by pit depth (measured visually) and recovery time from grade 0-3. The scale is used to rate the severity and the scores are as follows: \- Grade 0: No clinical edema- Grade 1: Slight pitting (up to 2 mm depth) - Grade 2: Moderate pitting (2-5 mm) - Grade 3: Noticeably deep pit (\>5 mm)
Skinfold thickness after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL
Evaluation of different outcome parameters in the patients from the 'intensive group' with unilateral LLL and patients with bilateral LLL: Skinfold test at the level of the foot, leg and midline region: Skin and subcutaneous tissue is lifted between thumb and index(and, if possible, compared to the contralateral side) Outcome:If skinfold is increased; yes(1), otherwise; no(0)
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KU Leuven
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborator
Nij Smellinghe Hospital Drachten
Collaborator
