The trial aims to determine whether the dynamic compression device, used in combination with elastic compression garments, is non-inferior to currently available compression devices (CACD) during the maintenance phase of lower-limb lymphoedema treatment.
This is a two-arm, parallel-group trial. Both groups will include patients being discharged after the inpatient intensive treatment phase for lower-limb lymphoedema. Eligible participants will be enrolled on the afternoon of their final inpatient treatment day, prior to discharge.
Participants will be allocated to one of the following groups:
DDS group: elastic compression garment worn at least during the day and as often as possible during the night, according to patient preference and expert advice, plus DDS use for a minimum of 2 hours at the end of the day, used alone without an elastic garment.
Control group: elastic compression garment worn at least during the day and as often as possible during the night, according to patient preference and expert advice, plus currently available compression devices, including multicomponent bandages, pneumatic compression devices, and compression wraps, according to patient preference and the center's recommendations.
Manual lymphatic drainage will be permitted in both groups.
Patients will undergo three assessment visits:
Visit 1 / Baseline-Inclusion (V1): afternoon of the final inpatient treatment day, prior to discharge from intensive treatment; Visit 2 (V2): end of week 6, ± 7 days; Visit 3 (V3): end of week 12, ± 7 days.
Age ≥ 18 years
Men and women
Unilateral lower limb lymphedema of stage II or III according to the criteria defined by the International Society of Lymphology
Patients completing an inpatient intensive treatment phase, including patients participating in CIV-25-01-050914, with a minimum of 20% of excess volume reduction
Patients with suspended lymphoedema of the thigh (unaffected calf and foot)
Patients with lipedema
Patients with bilateral lower limb lymphoedema
Patients with a lymphedema associated with active cancer requiring acute chemotherapy, or oncologic relapses, or treatment in progress
Parallel
Control group: Currently available compression devices
DeviceParticipant in the control group may use all currently available compression devices to treat their lymphoedema, in addition to the prescribed elastic garment(s).
DDS group: Dynamic compression device (DDS)
DevicePatients in the DDS group are limited to using the DDS device for a minimum of 2h at the end of the day as an adjuvant compression modality to the prescribed elastic garment(s).
Relative excess limb volume (%)
Change in relative excess limb volume (%) of the affected limb from baseline (Day 0) to the end of the 12-week maintenance phase treatment, based on circumferential tape measurements.
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.
Longitudinal change in the volume of the feet in ml
assessed by water volumetry (ValGrado method)
Dermal and subcutaneous tissue thickness in mm
assessed by ultrasound imaging
Compressibility of the skin and subcutaneous tissue in mm
assessed by ultrasound imaging under standardized weight
Safety outcome: Number of participants with adverse events and device-related safety issues over 12 weeks
The safety of the devices used in both groups will be assessed 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), device deficiency (DD), or serious/unexpected serious adverse reaction (S/USAR) during the study. Events will be summarized by category (AE, SAE, ADE, SADE, DD, S/USAR), 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 through their patient diaries. Unit of Measure Number of participants
Exploratory objectives: Assess the coherence between three volumetric methods
This exploratory outcome will assess the coherence between different tools used to quantify limb volume in lymphedema. The analysis will compare volume measurements obtained from a 3D scanner (EinStar VEGA), circumferential tape measurements, and a Perometer to evaluate the degree of correlation and agreement between these methods.
Exploratory coherence between methods of assessing skin and subcutaneous tissue thickness
This exploratory outcome will assess the coherence between different modalities used to evaluate skin and subcutaneous tissue thickness (mm). The analysis will compare measurements obtained from ultrasonography, compressibility assessment, and the pitting test to determine the degree of correlation and agreement between these methods.
Exploratory objective: To assess the coherence between data registered by the DDS integrated sensor system and clinical measurements.
This exploratory outcome will assess the coherence between data recorded by the integrated sensor system of the investigational compression device and selected clinical and patient-reported measures. The analysis will compare device-recorded signals with (1) tissue stiffness values obtained using a handheld myotonometer (MyotonPro), (2) limb volume estimates derived from circumferential tape measurements, and (3) weekly questionnaire responses in the adherence/observance domain. Coherence will be examined using correlation and agreement analyses to determine how closely sensor-derived data reflect these external measures.
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Jean-Paul Belgrado
Lead sponsor
Université Libre de Bruxelles
Sponsor institution
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