NCT04252690

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Thuasne · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphedema of Leg
• Lymphedema Congenital
• Lymphedema Primary
• Lymphedema, Secondary

Interventions

Type	Name	Description
DEVICE	MOBIDERM® autofit : auto-adjustable compression stocking	The experimental protocol will require 2 visits during usual reduction phase performed at the hospital (5 days of hospitalization). Visit 1 will be performed the first day of hospitalization and will consist of inclusion visit and some evaluations (lymphoscintigraphy, edema volume, cutaneous characteristics). Between visit 1 (D1) and visit 2 (D3), patients will wear Mobiderm Autofit continually. Visit 2 will be performed the third day of hospitalization and will consist of evaluations (lymphoscintigraphy, edema volume, cutaneous characteristics, satisfaction survey).

Timeline

• Start date: 2020-07-01
• Primary completion: 2022-06-23
• Completion: 2022-06-23
• First posted: 2020-02-05
• Last updated: 2023-04-26

Locations

1 site across 1 country: France