NCT06264817

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

A Multicenter, Single-blinded, Randomized Controlled Study to Assess the Efficacy of Auto-Adjustable MOBIDERL Autofit Armsleeve in the Management of Upper Limb Lymphedema. (LyberT)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Thuasne · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Lymphedema of Upper Limb

Interventions

Type	Name	Description
DEVICE	MOBIDERM Autofit Armsleeve	In the intervention group, during the intensive phase, patients wear day and night MOBIDERM AUTOFIT during 3 weeks. During the maintenance phase, patients wear usual compression sleeve during the day and MOBIDERM Autofit Armsleeve at night during 5 weeks
DEVICE	Compressive bandaging	In the control group, during the intensive phase, patients wear compressive bandaging day and night-time, according to the usual practice during 3 weeks. During the maintenance phase, patients wear usual compression sleeve during the day and self bandages at night during 5 weeks

Timeline

• Start date: 2024-03-15
• Primary completion: 2025-03-15
• Completion: 2025-04-15
• First posted: 2024-02-20
• Last updated: 2024-09-23

Locations

2 sites across 1 country: Turkey (Türkiye)