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

Primary Purpose

Lymphedema of Leg, Lymphedema Congenital, Lymphedema Primary

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MOBIDERM® autofit : auto-adjustable compression stocking
Sponsored by
Thuasne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lymphedema of Leg focused on measuring lymphedema,, auto-adjustable MOBIDERM® Autofit stocking, lymphoscintigraphy, mechanism of action

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHRU Tours

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mobiderm

Arm Description

MOBIDERM® autofit : auto-adjustable compression stocking

Outcomes

Primary Outcome Measures

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®

Secondary Outcome Measures

Change of vascular lymphatic activity between D1 and D3
Assess change of vascular lymphatic activity based on qualitative data (activity YES/NO ; quality of activity : usual - semi usual - unusual) obtained during dynamic acquisition of lymphoscintigraphy from baseline to D3
Change of lymphatic vascular flow between D1 and D3
Assess change of amplitude vascular flow : important - medium- weak ; and of flow velocity : normal, slow, inexistent from baseline to D3
Change on lymphatic system between D1 and D3 : short term effect
Assess change on lymphatic system from baseline to D3 (short term effect) , based on quantitative data : number of lympho node fixation ; and qualitative data: lympho node fixation intensity : important - medium - low ; tortuous appearance of the lymphatic vessels : YES/NO ; presence of collateral : YES/NO ; presence of dermal reflux : YES/NO ; presence of popliteal ganglion : YES/NO.
Change on lymphatic system between H2 and H4 : immediate effect
Assess change on lymphatic system from baseline to 2 and 4 hours : immediate effect, based on quantitative data : number of lympho node fixation ; and qualitative data: lympho node fixation intensity : important - medium - low ; tortuous appearance of the lymphatic vessels : YES/NO ; presence of collateral : YES/NO ; presence of dermal reflux : YES/NO ; presence of popliteal ganglion : YES/NO.
Lymphedema volume reduction between D1 and D3
Leg perimeters (cm) of 7 part of leg will be measured (ankle, patella, +10cm +20cm +30cm and -10cm -20cm and -30cm of patella). Based on truncated cone formula, volume (mL) of each leg will be calculated. These volumes will be compared between D1 and D3 in order to assess lymphedema volume reduction.
Skin condition evolution between D1 and D3
Skin condition will be assessed by cutaneous ultrasound scan (skin thickness (mm) , skin echogenicity (hypoechogenicity - isoechogenicity, hyperechogenicity) , oedema distribution in the dermis (superficial dermis - deep dermis - overall of dermis -hypodermis and dermis) performed on 3 areas : ankle, leg and thigh. Skin condition evolution will be assessed at D1 and D3.
Cutaneous suppleness between D1 and D3
Cutaneous suppleness evolution is assessed with a cutometer. Cutaneous suppleness is described by skin elasticity, elastic capacity and viscoelasticity. Cutometer measurements are expressed in millimetre (skin deformation, skin relaxation, skin extensibility) and will be presented as quantitative data.
Number of type of serious and non-serious Adverse Device Effects
Number and type of serious and non-serious Adverse Device Effects (ADE) will be reported during the study
Satisfaction regarding MOBIDERM
Satisfaction is measured by a satisfaction questionnaire wrote specifically for the study. This questionnaire is focused on positioning the product, comfort, esthetic and global satisfaction.

Full Information

First Posted
January 17, 2020
Last Updated
April 25, 2023
Sponsor
Thuasne
Collaborators
University Hospital, Tours, Delta Consultants
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1. Study Identification

Unique Protocol Identification Number
NCT04252690
Brief Title
Physiological Study to Assess Mechanism of Action of MOBIDERM® in Lower-limb Lymphedema Patients
Acronym
ACTIODERM
Official Title
Physiological Study to Assess Mechanism of Action of MOBIDERM® in Lower-limb Lymphedema Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
June 23, 2022 (Actual)
Study Completion Date
June 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thuasne
Collaborators
University Hospital, Tours, Delta Consultants

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema of Leg, Lymphedema Congenital, Lymphedema Primary, Lymphedema, Secondary
Keywords
lymphedema,, auto-adjustable MOBIDERM® Autofit stocking, lymphoscintigraphy, mechanism of action

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
non-randomized, open-labelled, monocentric study
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobiderm
Arm Type
Experimental
Arm Description
MOBIDERM® autofit : auto-adjustable compression stocking
Intervention Type
Device
Intervention Name(s)
MOBIDERM® autofit : auto-adjustable compression stocking
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from baseline extraction rates at 3 days after wearing MOBIDERM
Description
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®
Time Frame
Day : 3
Secondary Outcome Measure Information:
Title
Change of vascular lymphatic activity between D1 and D3
Description
Assess change of vascular lymphatic activity based on qualitative data (activity YES/NO ; quality of activity : usual - semi usual - unusual) obtained during dynamic acquisition of lymphoscintigraphy from baseline to D3
Time Frame
Day : 3
Title
Change of lymphatic vascular flow between D1 and D3
Description
Assess change of amplitude vascular flow : important - medium- weak ; and of flow velocity : normal, slow, inexistent from baseline to D3
Time Frame
Day : 3
Title
Change on lymphatic system between D1 and D3 : short term effect
Description
Assess change on lymphatic system from baseline to D3 (short term effect) , based on quantitative data : number of lympho node fixation ; and qualitative data: lympho node fixation intensity : important - medium - low ; tortuous appearance of the lymphatic vessels : YES/NO ; presence of collateral : YES/NO ; presence of dermal reflux : YES/NO ; presence of popliteal ganglion : YES/NO.
Time Frame
Day : 3
Title
Change on lymphatic system between H2 and H4 : immediate effect
Description
Assess change on lymphatic system from baseline to 2 and 4 hours : immediate effect, based on quantitative data : number of lympho node fixation ; and qualitative data: lympho node fixation intensity : important - medium - low ; tortuous appearance of the lymphatic vessels : YES/NO ; presence of collateral : YES/NO ; presence of dermal reflux : YES/NO ; presence of popliteal ganglion : YES/NO.
Time Frame
Hours : 2 and 4
Title
Lymphedema volume reduction between D1 and D3
Description
Leg perimeters (cm) of 7 part of leg will be measured (ankle, patella, +10cm +20cm +30cm and -10cm -20cm and -30cm of patella). Based on truncated cone formula, volume (mL) of each leg will be calculated. These volumes will be compared between D1 and D3 in order to assess lymphedema volume reduction.
Time Frame
Days : 1 and 3
Title
Skin condition evolution between D1 and D3
Description
Skin condition will be assessed by cutaneous ultrasound scan (skin thickness (mm) , skin echogenicity (hypoechogenicity - isoechogenicity, hyperechogenicity) , oedema distribution in the dermis (superficial dermis - deep dermis - overall of dermis -hypodermis and dermis) performed on 3 areas : ankle, leg and thigh. Skin condition evolution will be assessed at D1 and D3.
Time Frame
Days : 1 and 3
Title
Cutaneous suppleness between D1 and D3
Description
Cutaneous suppleness evolution is assessed with a cutometer. Cutaneous suppleness is described by skin elasticity, elastic capacity and viscoelasticity. Cutometer measurements are expressed in millimetre (skin deformation, skin relaxation, skin extensibility) and will be presented as quantitative data.
Time Frame
Days : 1 and 3
Title
Number of type of serious and non-serious Adverse Device Effects
Description
Number and type of serious and non-serious Adverse Device Effects (ADE) will be reported during the study
Time Frame
Day : 3
Title
Satisfaction regarding MOBIDERM
Description
Satisfaction is measured by a satisfaction questionnaire wrote specifically for the study. This questionnaire is focused on positioning the product, comfort, esthetic and global satisfaction.
Time Frame
Day : 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loïc VAILLANT, MD
Organizational Affiliation
University Hospital of Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28281052
Citation
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.
Results Reference
background
PubMed Identifier
24931830
Citation
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.
Results Reference
background

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

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