63
Participants
Start Date
July 1, 2020
Primary Completion Date
December 30, 2023
Study Completion Date
September 15, 2024
Control group : Day-time compression sleeve
"In the control group, patients wear only day-time compression garment : lymphatrex during 3 months.~The protocol will require 3 visits during the maintenance phase.~Visit 1 at day 0 (until 5 days after the end of hospital): includes the inclusion visit with the reception of devices and some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group).~Visit 2 at 30 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group)~Visite 3 at 90 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group)."
Intervention group : Day-time compression sleeve and Night-time MOBIDERM® Autofit
"In the intervention group, patients wear a day-time compression garment : lymphatrex and the night-time compression garment : MOBIDERM AUTOFIT during 3 months.~The protocol will require 3 visits during the maintenance phase.~Visit 1 at day 0 (until 5 days after the end of hospital): includes the inclusion visit with the reception of devices and some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group).~Visit 2 at 30 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group)~Visite 3 at 90 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group)."
CHRU Tours, Tours
Chu Grenoble, Grenoble
Chu Montpellier, Montpellier
Ghr Mulhouse, Mulhouse
CHU NICE, Nice
Nimes, Nîmes
Chu Toulouse, Toulouse
Turkey, Ankara
International Clinical Trials Association
OTHER
Thuasne
INDUSTRY