Assessment of the Efficacy of the Dynamic Decongestive System in the Intensive Phase of Lower Lim… (NCT07622615) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Assessment of the Efficacy of the Dynamic Decongestive System in the Intensive Phase of Lower Limb Lymphedema
France, Germany110 participantsStarted 2026-07-01
Plain-language 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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 diabeti…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Relative excess limb volume (%) during intensive treatment