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

THUASNE

Status: Enrolling

Conditions: Lymphedema of Upper Limb

Treatments: Device: Compressive bandaging; Device: MOBIDERM Autofit Armsleeve

Study type: Interventional

Funder types: Industry

Identifiers

NCT06264817

EC 48 LyberT

Details and patient eligibility

About

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

Full description

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Control group : compressive bandaging

Active Comparator group

Description:

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

Treatment:

Device: Compressive bandaging

Intervention group: MOBIDERM Autofit Armsleeve

Experimental group

Description:

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

Treatment:

Device: MOBIDERM Autofit Armsleeve