Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema.
ConditionLymphedema of Upper Limb
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThuasne
About this trial
This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess compared to the compression bandages to manage the volume of upper limb lymphedema in patients with breast cancer related lymphedema
Eligibility criteria
Qualifiers
Unilateral secondary upper limb lymphedema of stage II or III according to the criteria defined by the International Society of Lymphology, following breast cancer
Volume difference between affected and healthy arm ≥ 10%
Affected arm that fits with one of the 6 standard sizes of the Auto- Adjustable MOBIDERM Autofit armsleeve provided.
Signed informed consent prior to any study-mandated procedure.
Disqualifiers
Stage I lymphedema or located in several places.
Patients for whom compression is contraindicated.
Lymphedema associated with active cancer needing acute chemotherapy or having recurrence or metastasis.
Motor and sensitive neurological deficiency / psychiatric or addictive disorders
Trial design
Treatments tested in this trial
- MOBIDERM Autofit Armsleeve
- Compressive bandaging
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov