Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema
NCT ID: NCT02253186
Last Updated: 2015-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2014-09-30
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group I
Patients wear, for 90 days, the experimental Auto-Adjustable MOBIDERM® Armsleeve during night-time and a usual custom-made compressive armsleeve during Day-time.
Auto-Adjustable MOBIDERM Armsleeve
Group II
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.
No interventions assigned to this group
Interventions
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Auto-Adjustable MOBIDERM Armsleeve
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Thuasne
INDUSTRY
Responsible Party
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Principal Investigators
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Isabelle Quere, Prof
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Locations
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CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires
Montpellier, , France
Countries
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Other Identifiers
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2014-A01008-39
Identifier Type: -
Identifier Source: org_study_id