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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lymphedema

Intervention / Treatment
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* Device: Auto-Adjustable MOBIDERM Armsleeve


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>Patients wear, for 90 days, the experimental Auto-Adjustable MOBIDERM® Armsleeve during night-time and a usual custom-made compressive armsleeve during Day-time. | Device: Auto-Adjustable MOBIDERM Armsleeve<br> <br> * Other names: MOBIDERM Autofit;|
| No Intervention: Group II<br>Patients wear, for 30 days, only a usual custom-made compressive armsleeve during Day-time and no garment during night-time. Then, for the next 60 days, patients wear the experimental Auto-Adjustable MOBIDERM® Armsleeve during night-time and a usual custom-made compressive armsleeve during Day-time. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in excess arm volume | Excess arm volume is defined as the volumetric difference between the affected upper limb compared to the contralateral upper limb, calculated with truncated cone formula | between Day 0 and Day 30 |