Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema

Not Applicable

Completed

• Conditions: Lymphedema
• Interventions: Device: Auto-Adjustable MOBIDERM Armsleeve

• Registration Number: NCT02253186
• Lead Sponsor: Thuasne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-24
• Study First Submitted QC: 2014-09-30
• Study First Posted: 2014-10-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-04
• Last Update Posted: 2015-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Auto-Adjustable MOBIDERM Armsleeve	Patients wear, for 90 days, the experimental Auto-Adjustable MOBIDERM® Armsleeve during night-time and a usual custom-made compressive armsleeve during Day-time.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires; 🇫🇷 Montpellier Cedex 5, France