Assessment of the Efficacy of the Dynamic Decongestive System in the Intensive Phase of Lower Limb Lymphedema

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

Overview

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

• Device Control 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
• Device 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.

Primary outcome measures

• Relative excess limb volume (%) during intensive treatment [Time frame: 5 days]

Secondary outcome measures (8)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

France · 2 centers

• CHU Montpellier - Saint Eloi — Montpellier
• CHU Toulouse - Rangueil — Toulouse

Germany · 1 center

• Lympho-Opt Fachklinik fur Lymphologie — Pommelsbrunn

Identifiers

NCT: NCT07622615 · V1.3_11052026 · CIV-25-01-050914 · ID-RCB: 2025-A02610-49

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗