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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | Patients wear, for 90 days, the experimental Auto-Adjustable MOBIDERM® Armsleeve during night-time and a usual custom-made compressive armsleeve during Day-time. |
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| Group II | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auto-Adjustable MOBIDERM Armsleeve | Device |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle Quere, Prof | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires | Montpellier | 34295 | France |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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