NCT02253186
Completed
Not Applicable
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
ConditionsLymphedema
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Thuasne
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in excess arm volume
Overview
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 hosiery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in excess arm volume
Time Frame: between Day 0 and Day 30
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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