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

Lymphedema of Leg Clinical Trial

Official title:
Physiological Study to Assess Mechanism of Action of MOBIDERM® in Lower-limb Lymphedema Patients

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04252690
Study type Interventional
Source Thuasne
Contact
Status Completed
Phase N/A
Start date July 1, 2020
Completion date June 23, 2022
View Details
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