Status:
COMPLETED
Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema
Lead Sponsor:
Thuasne
Conditions:
Lymphedema
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02253186
Start Date
September 1 2014
End Date
June 1 2015
Last Update
December 7 2015
Active Locations (1)
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1
CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires
Montpellier, France, 34295