Lymphedema Lower ExtremityEDYDES-intNCT07622615
Assessment of the Efficacy of the Dynamic Decongestive System in the Intensive 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 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. 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
- 110 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jul 2026to 30 Dec 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 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 requiring intensive decongestive treatment in a hospital setting
- Patients who have given their informed consent freely and signed it prior to any intervention in the study.
Show all 9Show fewer
- 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 lymphoedema 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 29Show fewer
- Advanced diabetic microangiopathy
- Deep/Superficial active or recent venous thrombosis, phlegmasia ceruela dolens (painful blue inflammation), septic/acute thrombophlebitis of the limb (in the last 6 months), active venous leg ulcers
- 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
- Cardiac insufficiency (compensated or decompensated)
- Implantable stimulation devices such as pacemaker
- Chronic kidney disease with acute renal failure
- Epilepsy
- Poorly controlled asthma
- 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
- 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, malloizel-delaunay.j@chu-toulouse.fr
Alessandra Bura-Rivière, Prof, +33 668 91 58, 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 Intensive Phase of Lower Limb Lymphedema Treatment
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)
Read the detailed description
Background Lymphedema is a chronic, incurable swelling of the limbs that requires an initial intensive decongestive phase followed by lifelong maintenance based mainly on compression. Properly delivered, this two phase approach can significantly reduce limb volume, lower infection risk, and improve quality of life, but the condition remains under recognized, stigmatizing, and costly for patients and health systems.
Lymphedema markedly impairs daily function, mobility, body image, and mental health, and is associated with anxiety, depression, sexual dysfunction, social isolation, and work limitations. In Europe, most secondary lymphedema cases arise after cancer surgery and adjuvant therapies, particularly for breast, gynecologic, gastrointestinal, melanoma, and prostate cancers, with an increasing burden of lower limb disease linked in part to improved cancer survival and the diffusion of robotic surgery.
Management guidelines (e.g., HAS, ISL) recommend multidisciplinary care and intensive decongestive treatment (IDT) when excess volume is significant, followed by maintenance. IDT typically combines daily multi component bandaging (MCB), exercise, skin care, and manual lymphatic drainage, the latter mainly for comfort and adherence rather than proven decongestive efficacy. A key goal is maximum volume reduction, which drives functional, preventive, and psychological benefits and prepares patients for the long maintenance phase. MCBs remain the cornerstone of physical decongestion. However, they require frequent tightening as volume decreases, involve complex, time consuming multilayer application with substantial material costs, and are highly operator dependent.
They also motivate the search for improved compression technologies-especially dynamic systems that are quick and easy to apply, less operator dependent, to optimize decongestion, support long term self management, and reduce overall costs.
- Conditions
- Lymphedema Lower Extremity
- Being tested
- Control group: Traditional multicomponent bandages, 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: Traditional multicomponent bandagesDevice
In 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)Device
Patients 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.
| Study group | Role | What they receive |
|---|---|---|
| Control group: Traditional multicomponent bandages | Active comparator | Control group: Traditional multicomponent bandages Patients in the control group will receive the standard inpatient intensive treatment for lower limb lymphoedema including: compression, manula lymphatci drainage, skin care and exercise Receives: Device: Control group: Traditional multicomponent bandages |
| DDS group: Dynamic compression device (DDS) | Experimental | DDS group: Dynamic compression device (DDS) Patients in the DDS group will undergo the standard inpatient intensive treatment for lower limb lymphoedema including compression therapy, manual lymphatic drainage, skin care and exercise. 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 (%) 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.
Measured: 5 days
Secondary outcomes (8)
Application/removal time (hh/mm)
Time for application of the compression devices measured in minutes at each measurement sessions.
Measured: 5 days
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
Measured: 5 days
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)
Measured: 5 days
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: 2 hours / 3 days
Patient-reported satisfaction with the aesthetics of the DDS device
Satisfaction with the aesthetics of the DDS device will be assessed using item 19 of the Patient Satisfaction Questionnaire ("Overall are you satified with the aesthetics of the device?"), rated on a 4-point Likert scale (1 = Very unsatisfied, 2 = Unsatisfied, 3 = Satisfied, 4 = Versy satisfied). For each treatment arm, the mean score and distribution of responses will be reported. Higher scores indicate greater satisfaction with the aesthetics of the device.
Outcome Measure Unit of Measure Units on a 4-point Likert scale (1-4)
Measured: 5 days
Patient-reported comfort of the DDS device
Comfort of the DDS device will be assessed using item 1 of the Patient Satisfaction Questionnaire ("How do you evaluate the comfort of the device?"), where comfort is rated on a 4-point Likert scale (1 = Very uncomfortable, 2 = Uncomfortable, 3 = Comfortable, 4 = Very comfortable) across several conditions (daytime at rest/in movement, night, calf/thigh, liner). For each participant, a composite comfort score will be calculated as the arithmetic mean of all available item-level ratings (excluding responses marked "NA"). For each treatment arm, the mean composite comfort score and distribution of responses for the overall composite will be reported. Higher scores indicate greater perceived comfort.
Outcome Measure Unit of Measure Units on a 4-point Likert scale (1-4)
Measured: 5 days
Patient-reported usability of the DDS device
Usability of the DDS device will be assessed using items 8, 9, 10, 11 and 12 of the Patient Satisfaction Questionnaire (intuitiveness of application, clarity of instructions for use and maintenance, clarity of contraindications and warnings, and ease of using key device functions). Individual questions are rated on 4-point Likert scales (e.g. Very easy- Very difficult, Very clear - Unclear). Response options will be coded so that higher values reflect better usability (e.g. 1 = Very difficult / unclear up to 4 = Very easy / very clear). For each participant, a composite usability score will be calculated as the arithmetic mean of all coded items with non-missing responses. For each treatment arm, the mean composite usability score and distribution of composite scores will be reported. Higher scores indicate better perceived usability.
Outcome Measure Unit of Measure Units on a 4-point Likert scale (1-4)
Measured: 5 days
Number of participants intending to continue use of the DDS device after the clinical study
Intention to continue using the DDS device will be assessed using item 21 of the Patient Satisfaction Questionnaire ("Outside of the clinical trial, do you plan to continue wearing the device: During the intensive phase? During the maintenance phase?"), each with Yes/No response options. The primary reported value will be the number and percentage of participants who answer "Yes" for continued use during the maintenance phase. Numbers and percentages for the intensive phase will be reported descriptively.
Outcome Measure Unit of Measure Number of participants
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 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
- 110 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
- NCT07622615
- Sponsor's protocol ID
- V1.3_11052026
- Other IDs
- CIV-25-01-050914, ID-RCB: 2025-A02610-49
- Acronym
- EDYDES-int
- Status last verified
- May 2026
- First submitted
- 2 May 2026
- Last updated
- 3 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 3 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 Intensive Phase of Lower Limb Lymphedema Treatment
- ClinicalTrials.gov ID
- NCT07622615
- Acronym / sponsor ID
- EDYDES-int / 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
- 110 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 Dec 2027 (estimated)
- First posted
- 3 Jun 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 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)
Detailed description
Background Lymphedema is a chronic, incurable swelling of the limbs that requires an initial intensive decongestive phase followed by lifelong maintenance based mainly on compression. Properly delivered, this two phase approach can significantly reduce limb volume, lower infection risk, and improve quality of life, but the condition remains under recognized, stigmatizing, and costly for patients and health systems.
Lymphedema markedly impairs daily function, mobility, body image, and mental health, and is associated with anxiety, depression, sexual dysfunction, social isolation, and work limitations. In Europe, most secondary lymphedema cases arise after cancer surgery and adjuvant therapies, particularly for breast, gynecologic, gastrointestinal, melanoma, and prostate cancers, with an increasing burden of lower limb disease linked in part to improved cancer survival and the diffusion of robotic surgery.
Management guidelines (e.g., HAS, ISL) recommend multidisciplinary care and intensive decongestive treatment (IDT) when excess volume is significant, followed by maintenance. IDT typically combines daily multi component bandaging (MCB), exercise, skin care, and manual lymphatic drainage, the latter mainly for comfort and adherence rather than proven decongestive efficacy. A key goal is maximum volume reduction, which drives functional, preventive, and psychological benefits and prepares patients for the long maintenance phase. MCBs remain the cornerstone of physical decongestion. However, they require frequent tightening as volume decreases, involve complex, time consuming multilayer application with substantial material costs, and are highly operator dependent.
They also motivate the search for improved compression technologies-especially dynamic systems that are quick and easy to apply, less operator dependent, to optimize decongestion, support long term self management, and reduce overall costs.
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: Traditional multicomponent bandages | Active comparator | Device: Control group: Traditional multicomponent bandagesControl group: Traditional multicomponent bandages Patients in the control group will receive the standard inpatient intensive treatment for lower limb lymphoedema including: compression, manula lymphatci drainage, skin care and exercise |
| DDS group: Dynamic compression device (DDS) | Experimental | Device: DDS group: Dynamic compression device (DDS)DDS group: Dynamic compression device (DDS) Patients in the DDS group will undergo the standard inpatient intensive treatment for lower limb lymphoedema including compression therapy, manual lymphatic drainage, skin care and exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 requiring intensive decongestive treatment in a hospital setting
Key exclusion criteria (29 listed)
- 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
- 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: Traditional multicomponent bandagesIn the control group, patients will wear traditional multicomponent bandages as a compression therapy modality 24/24 during the first 5 days of intensive treatment | Device | Control group: Traditional multicomponent bandages |
| DDS group: Dynamic compression device (DDS)Patients 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. | Device | DDS group: Dynamic compression device (DDS) |
Primary outcome
Relative excess limb volume (%) during intensive treatment
Time frame: 5 days
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.
8 secondary outcomes
Application/removal time (hh/mm)
Time frame: 5 days
Mean interface pressure amplitude (mmHg) at the skin-bandage interface during standardized maneuvers
Time frame: 5 days
Patient-reported overall satisfaction with the DDS device
Time frame: 5 days
Longitudinal change in excess volume of the affected limb in ml
Time frame: 2 hours / 3 days
Patient-reported satisfaction with the aesthetics of the DDS device
Time frame: 5 days
Patient-reported comfort of the DDS device
Time frame: 5 days
Patient-reported usability of the DDS device
Time frame: 5 days
Number of participants intending to continue use of the DDS device after the clinical study
Time frame: 5 days
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 3 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 9 inclusion and 29 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 3 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 (%) during intensive treatment (time frame: 5 days). 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 3 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.