Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2025-04-15

Brief Summary

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This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess compared to the compression bandages to manage the volume of upper limb lymphedema in patients with breast cancer related lymphedema

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Detailed Description

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The overall range of compression devices dedicated to lymphedema treatment offers standard or custom-made garments and different types of bandages. Indeed, bandages are not easy to put on, requiring specific patient's skills and/or assistance which is not optimal for long-term compliance. Moreover, they are composed of several layers forming a quite bulky multilayer bandage that limits limb function and does not contribute to a better quality of life. For all these reasons described, even if bandaging is the current reference of lymphedema treatment, they have disadvantages.

The day-time elastic compressive armsleeves are proposed as an alternative to bandages. However, whatever their standard or custom-made design, they cannot adapt to limb volume/morphology evolution on the long-term management of this chronic disease because they are not adjustable. Therefore, as the comfort of treatment is very important in improving compliance, armsleeves are sometimes poorly tolerated by patients resulting in decreasing compliance to treatment plan.

In order to optimize treatment of lymphedema efficacy, THUASNE developed the standard Auto-Adjustable Armsleeve using the MOBIDERM technology.

Conditions

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Lymphedema of Upper Limb

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, multi-center, interventional, controlled-randomized, single blinded study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

For the same patient, all measurements will be performed as far as possible by the same health professional who doesn't have the knowledge of patient's group.

Study Groups

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Control group : compressive bandaging

Control group : compressive bandaging:

* Intensive phase (3 weeks): compressive bandaging (day and night-time) according to the usual practice
* Maintenance phase (5 weeks): usual compression sleeve during the day + Self bandages at night

Group Type ACTIVE_COMPARATOR

Compressive bandaging

Intervention Type DEVICE

In the control group, during the intensive phase, patients wear compressive bandaging day and night-time, according to the usual practice during 3 weeks.

During the maintenance phase, patients wear usual compression sleeve during the day and self bandages at night during 5 weeks

Intervention group: MOBIDERM Autofit Armsleeve

Intervention group: MOBIDERM Autofit Armsleeve

* Intensive phase (3 weeks): MOBIDERM Autofit Armsleeve (day and night-time)
* Maintenance phase (5 weeks): usual compression sleeve during the day + MOBIDERM Autofit Armsleeve at night

Group Type EXPERIMENTAL

MOBIDERM Autofit Armsleeve

Intervention Type DEVICE

In the intervention group, during the intensive phase, patients wear day and night MOBIDERM AUTOFIT during 3 weeks.

During the maintenance phase, patients wear usual compression sleeve during the day and MOBIDERM Autofit Armsleeve at night during 5 weeks

Interventions

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MOBIDERM Autofit Armsleeve

In the intervention group, during the intensive phase, patients wear day and night MOBIDERM AUTOFIT during 3 weeks.

During the maintenance phase, patients wear usual compression sleeve during the day and MOBIDERM Autofit Armsleeve at night during 5 weeks

Intervention Type DEVICE

Compressive bandaging

In the control group, during the intensive phase, patients wear compressive bandaging day and night-time, according to the usual practice during 3 weeks.

During the maintenance phase, patients wear usual compression sleeve during the day and self bandages at night during 5 weeks

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Unilateral secondary upper limb lymphedema of stage II or III according to the criteria defined by the International Society of Lymphology, following breast cancer
* Volume difference between affected and healthy arm ≥ 10%
* Affected arm that fits with one of the 6 standard sizes of the Auto- Adjustable MOBIDERM Autofit armsleeve provided.
* Signed informed consent prior to any study-mandated procedure.

Exclusion Criteria

* Stage I lymphedema or located in several places.
* Patients for whom compression is contraindicated.
* Lymphedema associated with active cancer needing acute chemotherapy or having recurrence or metastasis.
* Motor and sensitive neurological deficiency / psychiatric or addictive disorders
* Pregnant or breastfeeding patient
* Patient intolerant to MOBIDERM Autofit or known allergies to the components used.
* Participation to any other clinical study which has an impact on the different endpoints
* Vulnerable patient, adults being the object of a legal protective measure or enable to express their consent.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No