The goal of this study is to compare the efficacy of a dynamic compression device (DDS) with traditional multicomponent bandages (TMCB) in terms of excess volume reduction in lower limb lymphoedema during the first 5 days of intensive treatment.
Participants in both groups will undergo the standard decongestive treatment protocol of the trial site. The only difference between both groups will be the modality of the compression therapy:
* the intervention (DDS) group will wear the compression 24/24 during the first 5 days of intensive treatment * the control group will wear TMCB 24/24 during the first 5 days of intensive treatment (i.e. the standard treatment)
Age ≥ 18 years
Men and women
Unilateral lower limb lymphoedema of stage II or III according to the criteria defined by the International Society of Lymphology
Relative volume difference between affected and healthy leg ≥ 10%
Patients with suspended lymphoedema of the thigh (unaffected calf and foot)
Patients with lipedema
Patients with bilateral lower limb lymphoedema
Patients with a lymphoedema associated with active cancer requiring acute chemotherapy, or oncologic relapses, or treatment in progress
Parallel
Control group: Traditional multicomponent bandages
DeviceIn the control group, patients will wear traditional multicomponent bandages as a compression therapy modality 24/24 during the first 5 days of intensive treatment
DDS group: Dynamic compression device (DDS)
DevicePatients in the DDS group will wera the inverventional dynamic compression device as a compression modality 24/24 during the first five days of inpatient intensive treatment.
Relative excess limb volume (%) during intensive treatment
The primary outcome is the relative excess limb volume reduction (percent change) during the first 5 days of intensive treatment. Relative excess volume (%) will be calculated from serial limb volume measurements obtained once or twice daily, according to the number of bandage applications in each center's standard protocol, and expressed as the percentage reduction from baseline. This percentage change will be compared between the two treatment groups, with higher percentage reduction indicating a better decongestive outcome.
Application/removal time (hh/mm)
Time for application of the compression devices measured in minutes at each measurement sessions.
Mean interface pressure amplitude (mmHg) at the skin-bandage interface during standardized maneuvers
The combined mean interface pressure amplitude (mmHg) during the two standardized maneuvers (supine dorsiflexion and standing tiptoeing), measured immediately after each compression system application and prior to its removal during the 5-day intensive treatment, will be calculated for each participant by averaging (with equal weight) the pressure amplitudes from the two maneuvers at each assessment. For each treatment arm (DDS and TMCB), the primary analysis will use the mean of these participant-level composite values across all participants. The primary comparison will test whether this combined mean interface pressure amplitude is higher under DDS than under TMCB, reflecting a superior massage effect. * H0 : µDDs - µTMBC ≤ 0 * H1 : µDDs - µTMBC \> 0
Patient-reported overall satisfaction with the DDS device
Overall satisfaction with the DDS device will be assessed using item 20 of the Patient Satisfaction Questionnaire ("Overall, are you satisfied with the device?"), rated on a 4-point Likert scale (1 = Very unsatisfied, 2 = Unsatisfied, 3 = Satisfied, 4 = Very satisfied). For each treatment arm, the mean score and distribution of responses (number and percentage of participants per category) will be reported. Higher scores indicate greater overall satisfaction with the device. Outcome Measure Unit of Measure Units on a 4-point Likert scale (1-4)
Longitudinal change in excess volume of the affected limb in ml
Excess limb volume changes will be measured in ml using three distinct methods: 1. circumferential tape measurements; 2. opto-electric volumetry; 3. 3D scanner.
Number of participants with adverse events and device-related safety issues
The safety of the DDS and TMCB devices will be evaluated by counting the number of participants who experience at least one adverse event (AE), serious adverse event (SAE), adverse device effect (ADE), serious adverse device effect (SADE), or device deficiency (DD) during the study, as well as the total number of events in each category. Events will be summarized by type (AE, SAE, ADE, SADE, DD), severity, and relationship to the investigational device for each treatment arm. All untoward events will be collected by investigators during the intervention and follow-up periods and by participants via patient diaries. Unit of Measure Number of participant
Exploratory outcomes: Longitudinal change in excess volume of the affected limb in ml
Excess volume in the affected limb will be measured in ml during the first 2 hours, 3 days, and 5 days of intensive using tow distinct methods: 1. opto-electric volumetry; 2. 3D scanner.
Exploratory outcome: Longitudinal change in foot volume of the affected limb in ml
Foot volume will be measured in ml at 2h, 3 days and 5 days of the intensive treatment phase using the ValGrado water displacement method.
Exploratory outcome: Lower limb contour area (cm2)
Lower limb contour changes based on standardized photos taken at baseline and Day 5 in cm and cm2.
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Jean-Paul Belgrado
Lead sponsor
Université Libre de Bruxelles
Sponsor institution
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