Lymphedema of LegACTIODERMNCT04252690
Physiological Study to Assess Mechanism of Action of MOBIDERM® in Lower-limb Lymphedema Patients
A study testing MOBIDERM® autofit : auto-adjustable compression stocking in people with Lymphedema of Leg and Lymphedema Congenital, run by Thuasne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema of Leg, Lymphedema Congenital, Lymphedema Primary
- What is being tested?
- MOBIDERM® autofit : auto-adjustable compression stocking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2020to 23 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- MOBIDERM® autofit : auto-adjustable compression stocking
- Keywords
- lymphedema,, auto-adjustable MOBIDERM® Autofit stocking, lymphoscintigraphy, mechanism of action
- Medical subject headings
- Lymphedema, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOBIDERM® autofit : auto-adjustable compression stockingDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Mobiderm | Experimental | MOBIDERM® autofit : auto-adjustable compression stocking Receives: Device: MOBIDERM® autofit : auto-adjustable compression stocking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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®
Measured: Day : 3
Secondary outcomes (9)
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
Measured: Day : 3
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
Measured: Day : 3
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.
Measured: Day : 3
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.
Measured: Hours : 2 and 4
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.
Measured: Days : 1 and 3
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.
Measured: Days : 1 and 3
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.
Measured: Days : 1 and 3
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
Measured: Day : 3
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.
Measured: Day : 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Jul 2020
- Primary completion23 Jun 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lymphedema of LegStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- non-randomized, open-labelled, monocentric study
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thuasne
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Tours, Delta Consultants
- Responsible party
- Sponsor
- Investigators
- Loïc VAILLANT, MD, Principal investigator, University Hospital of Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252690
- Sponsor's protocol ID
- EC18
- Other IDs
- ANSM
- Acronym
- ACTIODERM
- Status last verified
- Apr 2023
- First submitted
- 17 Jan 2020
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28281052Quere 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.
PubMed 24931830
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Study to Assess Mechanism of Action of MOBIDERM® in Lower-limb Lymphedema Patients
- ClinicalTrials.gov ID
- NCT04252690
- Acronym / sponsor ID
- ACTIODERM / EC18
- Keywords
- lymphedema,, auto-adjustable MOBIDERM® Autofit stocking, lymphoscintigraphy, mechanism of action
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- ThuasneIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Tours, Delta Consultants
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non-randomized, open-labelled, monocentric study
| Arm | Type | Receives |
|---|---|---|
| Mobiderm | Experimental | Device: MOBIDERM® autofit : auto-adjustable compression stockingMOBIDERM® autofit : auto-adjustable compression stocking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOBIDERM® autofit : auto-adjustable compression stockingThe 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). | Device | Mobiderm |
Primary outcome
Change from baseline extraction rates at 3 days after wearing MOBIDERM
Time frame: Day : 3
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®
9 secondary outcomes
Change of vascular lymphatic activity between D1 and D3
Time frame: Day : 3
Change of lymphatic vascular flow between D1 and D3
Time frame: Day : 3
Change on lymphatic system between D1 and D3 : short term effect
Time frame: Day : 3
Change on lymphatic system between H2 and H4 : immediate effect
Time frame: Hours : 2 and 4
Lymphedema volume reduction between D1 and D3
Time frame: Days : 1 and 3
Skin condition evolution between D1 and D3
Time frame: Days : 1 and 3
Cutaneous suppleness between D1 and D3
Time frame: Days : 1 and 3
Number of type of serious and non-serious Adverse Device Effects
Time frame: Day : 3
Satisfaction regarding MOBIDERM
Time frame: Day : 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Background: PubMed 28281052Mestre 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.
- Background: PubMed 24931830Quere 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loïc VAILLANT, MD principal investigator
University Hospital of Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOBIDERM® autofit : auto-adjustable compression stocking in people with Lymphedema of Leg and Lymphedema Congenital, run by Thuasne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline extraction rates at 3 days after wearing MOBIDERM (time frame: Day : 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04252690, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.