Clinical trial NCT04252690: Physiological Study to Assess Mechanism of Action of MOBIDERM® in Lower-limb Lymphedema Patients
Official title: Physiological Study to Assess Mechanism of Action of MOBIDERM® in Lower-limb Lymphedema Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema of Leg
Lymphedema Congenital
Lymphedema Primary
Lymphedema, Secondary
Keywords: lymphedema,
auto-adjustable MOBIDERM® Autofit stocking
lymphoscintigraphy
mechanism of action
Lead sponsor: Thuasne
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Tours
name: Delta Consultants
First posted: 2020-02-05
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: non-randomized, open-labelled, monocentric study
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline extraction rates at 3 days after wearing MOBIDERM
timeFrame: Day : 3
Secondary outcomes:
measure: Change of vascular lymphatic activity between D1 and D3
timeFrame: Day : 3
measure: Change of lymphatic vascular flow between D1 and D3
timeFrame: Day : 3
measure: Change on lymphatic system between D1 and D3 : short term effect
timeFrame: Day : 3
measure: Change on lymphatic system between H2 and H4 : immediate effect
timeFrame: Hours : 2 and 4
measure: Lymphedema volume reduction between D1 and D3
timeFrame: Days : 1 and 3
measure: Skin condition evolution between D1 and D3
timeFrame: Days : 1 and 3
measure: Cutaneous suppleness between D1 and D3
timeFrame: Days : 1 and 3
measure: Number of type of serious and non-serious Adverse Device Effects
timeFrame: Day : 3
measure: Satisfaction regarding MOBIDERM
timeFrame: Day : 3
Other outcomes:
Locations:
city: Tours
country: France
facility: CHRU Tours
Study officials:
affiliation: University Hospital of Tours
name: Loïc VAILLANT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mestre 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.
citation: Quere 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.