RecruitingNot ApplicableNCT06264817

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

A Multicenter, Single-blinded, Randomized Controlled Study to Assess the Efficacy of Auto-Adjustable MOBIDERL Autofit Armsleeve in the Management of Upper Limb Lymphedema. (LyberT)

Sponsor

Thuasne

Enrollment

40 participants

Start Date

Mar 15, 2024

Study Type

INTERVENTIONAL

Conditions

Lymphedema of Upper Limb

Summary

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

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

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 Criteria8

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEMOBIDERM 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

DEVICECompressive 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