Clinical trial · Interventional
Physiological Study to Assess Mechanism of Action of MOBIDERM® in Lower-limb Lymphedema Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
MOBIDERM® demonstrated his interest through clinical studies on the treatment of lower or upper limb lymphedema (Mestre et al 2017; Quéré et al. 2014). This CE (Conformity European)-marking device is well established both in ambulatory and hospitalisation. Nevertheless, the mechanism of action of this device had never been confirmed and no experimental clinical studies had been performed. The hypothesis is that the MOBIDERM system creates a pressure differential between the contact zone underneath the foam cubes composing the system and their surrounding area, leading to a shear effect on the subcutaneous tissues treated. The aim of this study is thus to assess the mechanism of action of MOBIDERM on the lymphatic system by evaluating quantitative and qualitative effects of this medical device on lymphatic system, oedema volume and cutaneous parameters in 10 lymphoedema patients during their hospitalisation for reduction phase.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema Congenital | — | UNRESOLVED | — |
| Lymphedema of Leg | — | UNRESOLVED | — |
| Lymphedema Primary | — | UNRESOLVED | — |
| Lymphedema, Secondary | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MOBIDERM® autofit : auto-adjustable compression stocking | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mobiderm
- description
- MOBIDERM® autofit : auto-adjustable compression stocking
- interventionNames
- Device: MOBIDERM® autofit : auto-adjustable compression stocking
Primary outcomes (1)
- measure
- Change from baseline extraction rates at 3 days after wearing MOBIDERM
- timeFrame
- Day : 3
- description
- Assess the difference of extraction rate (%) in different areas (ankle, upper and lower middle third of the leg, knee, calf) by lymphoscintigraphy performed at D1 and D3 after wearing MOBIDERM®
Secondary outcomes (9)
- measure
- Change of vascular lymphatic activity between D1 and D3
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Primary or secondary lower limb lymphedema of stage 2 or 3 according to the criteria defined by International Society of Lymphology * Affected leg that fits with one of the standard sizes of the Auto-Adjustable MOBIDERM® Autofit stocking provided * Signed informed consent prior to any study-mandated procedure. Exclusion Criteria: * Pregnant or breastfeeding patient * Childbearing age patient without contraception * Intolerance to Mobiderm or known allergy to the components used * Evolutive lower limb infection * Acute lower limb inflammation * Dermatological ailment oozing from the treated limb * Severe medical condition that may interfere with the proper conduct of the study * Advanced diabetic microangiopathy * Limb arteritis stage III or IV * Decompensated heart failure * Involvement in another clinical study * Patient mentally incapable of understanding the nature, objectives and possible consequences of the study and / or refusing to submit to the constraints of this trial
References
Publications (2)
- BACKGROUNDMestre S, Calais C, Gaillard G, Nou M, Pasqualini M, Ben Amor C, Quere I. Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM(R) Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT. Support Care Cancer. 2017 Aug;25(8):2455-2462. doi: 10.1007/s00520-017-3652-5. Epub 2017 Mar 9. PMID 28281052
- BACKGROUNDQuere I, Presles E, Coupe M, Vignes S, Vaillant L, Eveno D, Laporte S, Leizorovicz A; POLIT Study investigators. Prospective multicentre observational study of lymphedema therapy: POLIT study. J Mal Vasc. 2014 Jul;39(4):256-63. doi: 10.1016/j.jmv.2014.05.004. Epub 2014 Jun 12. PMID 24931830