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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-25-10-054914 | Other Identifier | EUDAMED | |
| ID-RCB: 2025-A0810-49 | Other Identifier | French National Competent Authority - ANSM |
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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.
Background:
Lymphedema is a chronic, progressive condition characterized by impaired lymphatic drainage, leading to the accumulation of protein-rich fluid in the interstitial tissues, progressive tissue remodeling, and an increased risk of complications such as infection. Although lymphedema is not curable, standard management combining intensive decongestive therapy followed by lifelong maintenance treatment can significantly reduce limb volume, improve function, and enhance quality of life. However, maintaining long-term disease control remains challenging.
The maintenance phase relies primarily on compression therapy and patient self-management. Adherence is often suboptimal due to treatment complexity, cost, limited access to specialized care, and the impact of therapy on daily activities. As a result, patients frequently experience recurrent edema, functional impairment, and infectious complications such as cellulitis, contributing to a substantial clinical and socioeconomic burden.
Current standard approaches, including multicomponent bandaging and elastic compression garments, are effective but have important limitations. Multicomponent bandaging is highly operator-dependent, time-consuming, and difficult to maintain because frequent adjustments are required as limb volume changes. Elastic compression garments, while more practical, may be insufficient to achieve sustained decongestion, particularly in patients with moderate-to-severe disease. Overall, existing therapies often fail to provide consistent long-term edema control in real-world settings.
Recent technological advances have enabled the development of dynamic compression systems designed to improve usability and treatment consistency.
The Dynamic Decongestion System (DDS) is designed to standardize compression delivery, reduce operator dependency, and support patient autonomy in the home setting. This study aims to evaluate the clinical relevance of DDS as an adjunct to standard maintenance therapy in patients with primary or secondary lymphedema who have completed intensive decongestive treatment, with the objective of improving long-term volume control and reducing the overall burden of disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group: Currently available compression devices | Active Comparator | Control group: Currently available compression devices Patients in the control group will structure the maintenance phase treatment of their lower limb lymphoedema depending on personal preferences and the recommendations of their treating physician(s). |
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| DDS group: Dynamic compression device (DDS) | Experimental | Patients in the DDS group will structure the maintenance phase of thier lower limb lymphodema treatment depending on their personal preferences and the recommendations of their treating physician(s). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control group: Currently available compression devices | Device | Participant in the control group may use all currently available compression devices to treat their lymphoedema, in addition to the prescribed elastic garment(s). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Longitudinal change in the volume of the feet in ml |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Jean-Paul Belgrado, PhD | Contact | +33 6 38 39 79 56 | jp.belgrado@gmail.com | |
| Velika V Stoitchkova, MSc | Contact | +359 882 40 55 33 | velika.stoichkova@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Montpellier - Saint Eloi | Montpellier | 34090 | France |
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Prospective, multi-center, interventional, pre-market, pivotal, confirmatory, assessor-blinded study, randomized clinical trial
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| DDS group: Dynamic compression device (DDS) | Device | Patients 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). |
|
assessed by water volumetry (ValGrado method) |
| 12 weeks |
| Dermal and subcutaneous tissue thickness in mm | assessed by ultrasound imaging | 12 weeks |
| Compressibility of the skin and subcutaneous tissue in mm | assessed by ultrasound imaging under standardized weight | 12 weeks |
| Viscoelasticity of the skin and subcutaneous tissue complex | Viscoelasticity of the skin and subcutaneous tissue will be assessed using a handheld, non-invasive myotonometer (Myoton PRO). The device delivers a brief, low-force mechanical impulse through a probe placed on the skin and records the resulting damped oscillation of the underlying tissues, from which a quantitative viscoelasticity index is derived. | 12 weeks |
| Skin temperature of the affected limb (in C°) | based on far infrared thermography mapping | 12 weeks |
| Lower limb contour changes | based on standardized photos and measurements of surface area in cm2 | 12 weeks |
| Depth of the pitting sign in mm | based on standardized measurements | 12 weeks |
| Incremental cost-effectiveness ratio (ICER) of DDS versus CATP | Cost-effectiveness will be evaluated by calculating the incremental cost-effectiveness ratio (ICER) of DDS versus CATP over 12 weeks. The ICER will be defined as the difference in mean total cost per participant between DDS and CATP, divided by the difference in mean quality-adjusted life-years (QALYs) per participant, with QALYs derived from EQ-5D-5L utility scores collected during the study. A lower ICER (or dominance of one strategy) will indicate a more cost-effective option. Unit of Measure Cost per QALY gained | 12 weeks |
| Frequency of infectious episodes | collected via an ePROM on a weekly basis and by the investigator at V1, V2 and V3, including:
| 12 weeks |
| Patient-reported quality of life | Lymphedema-specific quality of life will be assessed using the Lymphoedema Quality of Life Questionnaire - Leg (LYMQOL-Leg), a validated, limb-specific patient-reported outcome measure for lower-limb lymphedema. The questionnaire includes multiple items covering domains such as function, appearance, symptoms, and mood, each rated on an ordinal scale; domain scores and an overall quality-of-life score are calculated by summing item responses. Scores typically range from a minimum of 1 to a maximum of 4 (or 10 for the global numerical rating scale, depending on the scoring convention used), with higher scores indicating a worse quality of life (greater impairment) in the evaluated domain. | 12 weeks |
| Patient's observance to compression therapy | Observance to compression therapy will be assessed using a composite measure based on device-recorded wear time from the investigational compression system and patient-reported use of all compression modalities (DDS device, bandages, garments, and other devices) collected through electronic patient-reported outcome questionnaires and/or patient diaries at week 6 (V2) and week 12 (V3). For each participant, the main adherence metric will be the percentage of prescribed daily wear time (hh:mm) achieved for the investigational device and for any other compression systems, separately for daytime and nighttime use. | 12 weeks |
| Patient comfort with compression therapy | Patient-reported comfort with compression therapy will be assessed using the International Compression Club Comfort Questionnaire Patient Version (ICC CQ-P), a validated comfort scale administered in both study groups at week 12. The ICC CQ-P total score is calculated as the sum of item responses, ranging from a minimum of 0 (worst comfort) to a maximum of 10 (best comfort). | 12 weeks |
| Long-term safety questionnaire (ancillary study) | Long-term safety and patient experience will be assessed in the ancillary follow-up study using a trial-specific electronic patient-reported outcome questionnaire. The questionnaire evaluates multiple domains related to long-term use of the device, including safety events (e.g., local symptoms or adverse effects), device usage patterns, patient satisfaction, adherence to prescribed use, and perceived device durability. The primary outcome will be a composite safety and usability profile derived from these domains, summarized descriptively over time; worse safety/experience is reflected by higher frequencies of device-related adverse events, lower adherence and satisfaction, and more frequent reports of device problems. | Ancillary study data will be collected quarterly for a period of up to three years (corresponding to the estimated lifespan of the device) or until CE-marking, whichever occurs first. |
| Device-specific comfort, ease of use, and satisfaction (trial-specific questionnaire, DDS group) | Among participants allocated to the investigational device, device-specific comfort, ease of use, and satisfaction will be assessed at week 12 using a trial-specific patient-reported questionnaire, including a Likert scale, biary responses (Yes/No), and open-ended questions. | 12 weeks |
| Mean total direct medical cost per participant over 12 weeks | Direct medical costs related to lymphoedema management will include costs of treatment modalities (manual lymph drainage, pressotherapy, mechanical devices, medications, skin care), lymphoedema-related healthcare consultations, hospitalizations and diagnostic procedures, and medical devices used during the 12-week period. For each participant, all relevant resource items will be recorded and valued using appropriate unit costs. For each treatment arm, the mean total direct medical cost per participant and standard deviation will be reported. Unit of Measure Currency units per participant (e.g. EUR per participant) | 12 weeks |
| Number of lymphoedema treatment sessions per participant over 12 weeks | Use of lymphoedema treatment modalities (manual lymph drainage, pressotherapy, mechanical devices, medications, skin care) will be recorded over 12 weeks, including frequency and duration of each treatment session and location (at home or outside the home). For each treatment arm, the mean number of treatment sessions per participant (by modality) and mean duration per session will be reported. Unit of Measure Number of sessions per participant | 12 weeks |
| Number and cost of medical devices used per participant over 12 weeks | All medical devices used for lymphoedema management during the 12-week period (including DDS or CATP and any additional devices) will be recorded. For each participant, the number of devices used and their associated costs will be documented. For each treatment arm, the mean number of devices per participant and mean device cost per participant will be reported. Unit of Measure Number of devices per participant and currency units per participan | 12 weeks |
| Mean out-of-pocket cost per participant over 12 weeks | Out-of-pocket costs borne by participants will include transportation costs (mode of transport, number of journeys, distance between home and hospital, travel time) and co-payments related to lymphoedema care. For each participant, all self-reported out-of-pocket expenses over the 12-week period will be recorded and summed. For each treatment arm, the mean total out-of-pocket cost per participant and standard deviation will be reported. Unit of Measure Currency units per participant | 12 weeks |
| Number of lymphoedema-related healthcare consultations and hospitalizations per participant over 12 weeks | Lymphoedema-related healthcare professional (HCP) resource use will include consultations with physiotherapists, nurses, lymphoedema specialists and other relevant HCPs, as well as hospitalizations. For each participant, the number of consultations (by HCP category), reasons for consultations, and the number and duration of hospitalizations will be recorded. For each treatment arm, the mean number of consultations and hospitalizations per participant and mean length of stay will be reported. Unit of Measure Number of events per participant | 12 weeks |
| 12 weeks |
| 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. | 12 weeks |
| 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. | 12 weeks |
| 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. | 12 weeks |
| CHU Toulouse - Rangueil | Toulouse | 31059 | France |
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| Lympho-Opt Fachklinik fur Lymphologie | Pommelsbrunn | Bavaria | 91224 | Germany |
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