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

NCT04252690 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-04-26

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • University Hospital, Tours

    collaborator OTHER

  • Delta Consultants

    collaborator UNKNOWN

  • Thuasne

    lead INDUSTRY

Principal Investigators

  • Loïc VAILLANT, MD · University Hospital of Tours

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-06-23
Completion
2022-06-23

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04252690 on ClinicalTrials.gov