Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema

Monocentre, Controlled, Randomized, Open Label, Clinical Study to Assess Safety and Efficacy of Auto-Adjustable MOBIDERM(R) Arm Sleeve in the Management of Upper Limb Lymphoedema During Night-time of Maintenance Phase

The objective of the study is to assess the effect of a new Armsleeve, worn during the night during maintenance phase of upper limb lymphoedema treatment in combination with Day-time usual lymphology hosiery.

Inclusion Criteria:

• Unilateral secondary upper limb lymphoedema of stage II or III, following breast cancer
• Patients hospitalized for an intensive phase of decongestive lymphoedema therapy (DLT) for whom a decrease of lymphoedema volume has been achieved during hospitalization
• Lymphoedema with evident pitting sign (assessed as ++ or +++)
• Requiring compression therapy for, at least, the next 3 months.
• Affected arm that fits with one of the 6 standard sizes of the Auto-Adjustable MOBIDERM® armsleeve provided.
• Signed informed consent prior to any study-mandated procedure.
• Not under any administrative or legal supervision.
• Covered by a health insurance system

Exclusion Criteria:

• Stage I lymphoedema
• Active cellulitis
• Lymphoedema associated with active cancer needing acute chemotherapy
• Motor and sensitive neurological deficiency
• Post-operative oedema (i.e acute oedema following breast cancer-related surgery)
• Patient participating in any other clinical study
• Unlikely to be followed up to 3 months with clinical assessment