Physiological Study to Assess Mechanism of Action of MOBIDERM® in Lower-limb Lymphedema Patients (ACTIODERM)

THUASNE

Status: Completed

Conditions: Lymphedema Congenital; Lymphedema, Secondary; Lymphedema Primary; Lymphedema of Leg

Treatments: Device: MOBIDERM® autofit : auto-adjustable compression stocking

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04252690

EC18

ANSM (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Mobiderm

Experimental group

Description:

MOBIDERM® autofit : auto-adjustable compression stocking

Treatment:

Device: MOBIDERM® autofit : auto-adjustable compression stocking