Lymphedema Lower Extremity
Conditions
Keywords
Complex decongestive therapy, Dynamic compression, Non-inferiority trial, Lymphoedema maintenance treatment, Limb volume reduction, Limb volume maintenance
Brief 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. 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.
Interventions
DEVICEControl group: Traditional multicomponent bandages
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
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.
Sponsors
Jean-Paul Belgrado
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Prospective, multi-center, interventional, pre-market, pivotal, confirmatory, assessor-blinded study, randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * 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.
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative excess limb volume (%) during intensive treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Application/removal time (hh/mm) | 5 days | 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 | 5 days | 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 | 5 days | 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 | 2 hours / 3 days | Excess limb volume changes will be measured in ml using three distinct methods: 1. circumferential tape measurements; 2. opto-electric volumetry; 3. 3D scanner. |
| Patient-reported satisfaction with the aesthetics of the DDS device | 5 days | 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) |
| Patient-reported comfort of the DDS device | 5 days | 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) |
| Patient-reported usability of the DDS device | 5 days | 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) |
| Number of participants intending to continue use of the DDS device after the clinical study | 5 days | 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 |
Countries
France, Germany
Contacts
CONTACTProf. Jean-Paul Belgrado, PhD
CONTACTVelika V Stoitchkova, MSc
Outcome results
None listed