Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema.

Last updated: September 20, 2024
Sponsor: Thuasne
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphedema

Treatment

Compressive bandaging

MOBIDERM Autofit Armsleeve

Clinical Study ID

NCT06264817
EC 48 LyberT
  • Ages > 18
  • Female

Study Summary

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

Inclusion

Inclusion Criteria:

  • Unilateral secondary upper limb lymphedema of stage II or III according to thecriteria 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- AdjustableMOBIDERM Autofit armsleeve provided.

  • Signed informed consent prior to any study-mandated procedure.

Exclusion

Exclusion Criteria:

  • Stage I lymphedema or located in several places.

  • Patients for whom compression is contraindicated.

  • Lymphedema associated with active cancer needing acute chemotherapy or havingrecurrence or metastasis.

  • Motor and sensitive neurological deficiency / psychiatric or addictive disorders

  • Pregnant or breastfeeding patient

  • Patient intolerant to MOBIDERM Autofit or known allergies to the components used.

  • Participation to any other clinical study which has an impact on the differentendpoints

  • Vulnerable patient, adults being the object of a legal protective measure or enableto express their consent.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Compressive bandaging
Phase:
Study Start date:
March 15, 2024
Estimated Completion Date:
April 15, 2025

Study Description

The overall range of compression devices dedicated to lymphedema treatment offers standard or custom-made garments and different types of bandages. Indeed, bandages are not easy to put on, requiring specific patient's skills and/or assistance which is not optimal for long-term compliance. Moreover, they are composed of several layers forming a quite bulky multilayer bandage that limits limb function and does not contribute to a better quality of life. For all these reasons described, even if bandaging is the current reference of lymphedema treatment, they have disadvantages.

The day-time elastic compressive armsleeves are proposed as an alternative to bandages. However, whatever their standard or custom-made design, they cannot adapt to limb volume/morphology evolution on the long-term management of this chronic disease because they are not adjustable. Therefore, as the comfort of treatment is very important in improving compliance, armsleeves are sometimes poorly tolerated by patients resulting in decreasing compliance to treatment plan.

In order to optimize treatment of lymphedema efficacy, THUASNE developed the standard Auto-Adjustable Armsleeve using the MOBIDERM technology.

Connect with a study center

  • ANKARA

    Ankara,
    Turkey

    Active - Recruiting

  • Pinar BORMAN

    Ankara,
    Turkey

    Active - Recruiting

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