Lymphedema Lower ExtremityEDYDES-maintNCT07603531
Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema
A study testing DDS group: Dynamic compression device (DDS) in people with Lymphedema Lower Extremity, run by Jean-Paul Belgrado at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema Lower Extremity
- What is being tested?
- DDS group: Dynamic compression device (DDS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jul 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 who have given their informed consent freely and signed it prior to any intervention in the study.
- Patients with a morphology compatible with the perimetric coverage of the device (calf and thigh).
- Patients able to use the device
- Patients enrolled in a social security plan or covered by similar health insurance.
Who cannot join
- 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
- Patients with contraindications for compression on the lower limbs such as stent/arterial graft in the area under compression
- Peripheral artery disease ABI ≤ 0.6
Show all 26Show fewer
- Advanced diabetic microangiopathy
- Active deep/superficial active or recent venous thrombosis, phlegmasia ceruela dolens (painful blue inflammation), active venous leg ulcers, septic/acute thrombophlebitis of the limb (in the last 6 months)
- A condition where increased venous or lymphatic return is undesirable
- Neurological disease (including neurogenic diabetic foot, severe peripheral neuropathy of the limb)
- Pulmonary embolism (last 6 months), pulmonary edema, poorly controlled asthma
- Cardiac insufficiency (compensated or decompensated)
- Implantable stimulation devices such as pacemaker
- Chronic kidney disease with acute renal failure
- Open skin lesions or skin and subcutaneous infection (cellulitis, erysipelas, lymphangitis, etc.)
- Skin atrophy of the limb
- Bullous dermatoses
- Presence of subcutaneous osteosynthesis material with an external component lying subdermally at the level of the treated lower limb
- Hyperalgesia of the foot, knee or hip
- Patients with a known allergy to the components used in the device
- Patients with psychiatric, psychological, or neurological disorders
- Patients with impaired cognitive or motor skills and dependent individuals
- Patients participating in another clinical trial
- Pregnant or breastfeeding women. Women of childbearing potential will undergo Clearblue® urine pregnancy testing prior to enrollment to verify eligibility.
- Vulnerable patients, adults being the object of a legal protective measure or unable to express their consent
- Patients unable to submit to the constraints of the protocol
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
France2 sites
CHU Montpellier - Saint Eloi
Montpellier, 34090
Sandrine Mestre, MD, +33 467 33 70 28, s-mestre@chu-montpellier.fr
Isabelle Quéré, Prof, +33 467 33 70 28, i-quere@chu-montpellier.fr
CHU Toulouse - Rangueil
Toulouse, 31059
Julie Malloizel, MD, +33 668 91 58 67, malloizel-delaunay.j@chu-toulouse.fr
Alessandra Bura-Rivière, Prof, +33 668 91 58 67, bura-riviere.a@chu-toulouse.fr
Germany1 site
Lympho-Opt Fachklinik fur Lymphologie
Pommelsbrunn, Bavaria, 91224
Franz-Josef Schingale, MD, +49 9154 911 200, franz-josef.schingale@lympho-opt.de
Britta Bockelmann, MD, +49 (0)178 628 5376, info@drb-bodensee.de
About this study
Official title: A Multicenter Controlled Randomised Clinical Trial to Assess the Efficacy of the Dynamic Decongestive System During the Maintenance Phase of Lower Limb Lymphedema Treatment
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Lymphedema Lower Extremity
- Being tested
- Control group: Currently available compression devices, DDS group: Dynamic compression device (DDS)
- Keywords
- Complex decongestive therapy, Dynamic compression, Non-inferiority trial, Lymphoedema maintenance treatment, Limb volume reduction, Limb volume maintenance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group: Currently available compression devicesDevice
Participant 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)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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Control group: Currently available compression devices |
| 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). Receives: Device: DDS group: Dynamic compression device (DDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (20)
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.
Measured: 12 weeks
Longitudinal change in the volume of the feet in ml
assessed by water volumetry (ValGrado method)
Measured: 12 weeks
Dermal and subcutaneous tissue thickness in mm
assessed by ultrasound imaging
Measured: 12 weeks
Compressibility of the skin and subcutaneous tissue in mm
assessed by ultrasound imaging under standardized weight
Measured: 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.
Measured: 12 weeks
Skin temperature of the affected limb (in C°)
based on far infrared thermography mapping
Measured: 12 weeks
Lower limb contour changes
based on standardized photos and measurements of surface area in cm2
Measured: 12 weeks
Depth of the pitting sign in mm
based on standardized measurements
Measured: 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
Measured: 12 weeks
Frequency of infectious episodes
collected via an ePROM on a weekly basis and by the investigator at V1, V2 and V3, including:
- Non-necrotizing dermo-hypodermitis
- Lymphangitis
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema Lower ExtremityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multi-center, interventional, pre-market, pivotal, confirmatory, assessor-blinded study, randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jean-Paul Belgrado
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jean-Paul Belgrado, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603531
- Sponsor's protocol ID
- DDS2 V1.3_11052026
- Other IDs
- CIV-25-10-054914, ID-RCB: 2025-A0810-49
- Acronym
- EDYDES-maint
- Status last verified
- May 2026
- First submitted
- 2 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Controlled Randomised Clinical Trial to Assess the Efficacy of the Dynamic Decongestive System During the Maintenance Phase of Lower Limb Lymphedema Treatment
- ClinicalTrials.gov ID
- NCT07603531
- Acronym / sponsor ID
- EDYDES-maint / DDS2 V1.3_11052026
- Conditions
- Lymphedema Lower Extremity
- Keywords
- Complex decongestive therapy, Dynamic compression, Non-inferiority trial, Lymphoedema maintenance treatment, Limb volume reduction, Limb volume maintenance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Jean-Paul BelgradoUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, multi-center, interventional, pre-market, pivotal, confirmatory, assessor-blinded study, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control group: Currently available compression devices | Active comparator | Device: Control group: Currently available compression devicesControl 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). |
| DDS group: Dynamic compression device (DDS) | Experimental | Device: DDS group: Dynamic compression device (DDS)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 who have given their informed consent freely and signed it prior to any intervention in the study.
Key exclusion criteria (26 listed)
- 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
- Patients with contraindications for compression on the lower limbs such as stent/arterial graft in the area under compression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control group: Currently available compression devicesParticipant in the control group may use all currently available compression devices to treat their lymphoedema, in addition to the prescribed elastic garment(s). | Device | Control group: Currently available compression devices |
| DDS group: Dynamic compression device (DDS)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). | Device | DDS group: Dynamic compression device (DDS) |
Primary outcome
Relative excess limb volume (%)
Time frame: 12 weeks
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.
20 secondary outcomes
Longitudinal change in excess volume of the affected limb in ml
Time frame: 12 weeks
Longitudinal change in the volume of the feet in ml
Time frame: 12 weeks
Dermal and subcutaneous tissue thickness in mm
Time frame: 12 weeks
Compressibility of the skin and subcutaneous tissue in mm
Time frame: 12 weeks
Viscoelasticity of the skin and subcutaneous tissue complex
Time frame: 12 weeks
Skin temperature of the affected limb (in C°)
Time frame: 12 weeks
Lower limb contour changes
Time frame: 12 weeks
Depth of the pitting sign in mm
Time frame: 12 weeks
Incremental cost-effectiveness ratio (ICER) of DDS versus CATP
Time frame: 12 weeks
Frequency of infectious episodes
Time frame: 12 weeks
Patient-reported quality of life
Time frame: 12 weeks
Patient's observance to compression therapy
Time frame: 12 weeks
Patient comfort with compression therapy
Time frame: 12 weeks
Long-term safety questionnaire (ancillary study)
Time frame: 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)
Time frame: 12 weeks
Mean total direct medical cost per participant over 12 weeks
Time frame: 12 weeks
Number of lymphoedema treatment sessions per participant over 12 weeks
Time frame: 12 weeks
Number and cost of medical devices used per participant over 12 weeks
Time frame: 12 weeks
Mean out-of-pocket cost per participant over 12 weeks
Time frame: 12 weeks
Number of lymphoedema-related healthcare consultations and hospitalizations per participant over 12 weeks
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DDS group: Dynamic compression device (DDS) in people with Lymphedema Lower Extremity, run by Jean-Paul Belgrado at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Jean-Paul Belgrado, PhD (+33 6 38 39 79 56, jp.belgrado@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative excess limb volume (%) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.