Lymphedema
Conditions
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.
Interventions
DEVICEAuto-Adjustable MOBIDERM Armsleeve
Sponsors
Thuasne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in excess arm volume | 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 |
Countries
France
Outcome results
None listed