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

Starting soon · Not applicable

Conditions studied: Lymphedema Lower Extremity

In brief

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)

Key facts

Study ID

NCT07622615

Run by

Jean-Paul Belgrado

People needed

110

Starts

2026-07-01

Expected to finish

2027-12-30

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• CHU Montpellier - Saint Eloi — Montpellier, France
• CHU Toulouse - Rangueil — Toulouse, France
• Lympho-Opt Fachklinik fur Lymphologie — Pommelsbrunn, Bavaria, Germany

Full record on ClinicalTrials.gov

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