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

NCT04252690 | Completed

• 2 other identifiers: EC18ANSM
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

lymphedema,; auto-adjustable MOBIDERM® Autofit stocking; lymphoscintigraphy; mechanism of action

Outcome Measures

Primary Outcomes (1)

• Change from baseline extraction rates at 3 days after wearing MOBIDERM

  Assess the difference of extraction rate (%) in different areas (ankle, upper and lower middle third of the leg, knee, calf) by lymphoscintigraphy performed at D1 and D3 after wearing MOBIDERM®

  Day : 3

Secondary Outcomes (9)

• Change of vascular lymphatic activity between D1 and D3

  Day : 3

• Change of lymphatic vascular flow between D1 and D3

  Day : 3

• Change on lymphatic system between D1 and D3 : short term effect

  Day : 3

• Change on lymphatic system between H2 and H4 : immediate effect

  Hours : 2 and 4

• Lymphedema volume reduction between D1 and D3

  Days : 1 and 3

Study Arms (1)

Mobiderm

EXPERIMENTAL

MOBIDERM® autofit : auto-adjustable compression stocking

Device: MOBIDERM® autofit : auto-adjustable compression stocking

Interventions

MOBIDERM® autofit : auto-adjustable compression stocking DEVICE

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).

Mobiderm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Thuasne: lead
• University Hospital, Tours: collaborator
• Delta Consultants: collaborator

Study Sites (1)

CHRU Tours

Tours, 37044, France

Location

Related Publications (2)

• 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.

  PMID: 28281052 BACKGROUND

• 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.

  PMID: 24931830 BACKGROUND

MeSH Terms

Conditions

Lymphedema; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Loïc VAILLANT, MD

  University Hospital of Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: non-randomized, open-labelled, monocentric study

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: February 5, 2020
• Study Start: July 1, 2020
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

FR (1)