New device aims to ease leg swelling in lymphedema patients
NCT ID NCT07603531
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if a new dynamic compression device, used with compression stockings, works as well as current treatments for reducing leg swelling in people with lymphedema. About 98 adults with stage II or III lymphedema will use either the new device or standard wraps and pumps for 12 weeks after intensive treatment. The goal is to see if the new device can help maintain swelling reduction and improve daily life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 98 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. 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 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
3 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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CHU Montpellier - Saint Eloi
Montpellier, 34090, France
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CHU Toulouse - Rangueil
Toulouse, 31059, France
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Lympho-Opt Fachklinik fur Lymphologie
Pommelsbrunn, Bavaria, 91224, Germany
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Exercise with or without compression: a new hope for leg swelling?
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- New wearable device aims to ease lymphedema swelling
- New questionnaire for leg swelling patients put to the test