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

NCT02253186 | Completed

• 1 other identifier: 2014-A01008-39
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (1)

• Change in excess arm volume

  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

  between Day 0 and Day 30

Study Arms (2)

Group I

EXPERIMENTAL

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

Device: Auto-Adjustable MOBIDERM Armsleeve

Group II

NO INTERVENTION

Patients wear, for 30 days, only a usual custom-made compressive armsleeve during Day-time and no garment during night-time. Then, for the next 60 days, patients wear the experimental Auto-Adjustable MOBIDERM® Armsleeve during night-time and a usual custom-made compressive armsleeve during Day-time.

Interventions

Auto-Adjustable MOBIDERM Armsleeve DEVICE

Also known as: MOBIDERM Autofit

Group I

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thuasne: lead

Study Sites (1)

CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Isabelle Quere, Prof

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: October 1, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 7, 2015

Record last verified: 2015-12

Locations

FR (1)