The primary objective is to collect real-life data to evaluate the clinical performance and safety of innovative, made-to-measure, flat knitted, CE-marked compression garments for daytime treatment of leg or arm lymphedema (ISL stage I-II) in daily routine by analysing performance parameters and safety parameters reported during the investigation.
The secondary objective is to evaluate (1) patients' quality of life QoL before and after having tested JOBST Confidence and (2) patient satisfaction focussing on patient reported outcomes of previously worn garments and JOBST® Confidence by analysing patient questionnaires parameters completed at the beginning and in the end of the wearing period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
99
JOBST® Confidence (JC) compression garments will be used for daytime treatment of leg or arm lymphedema. JC compression garments exert a specific therapeutic external, physical compression level and are therefore intended to use for the management of edema. JC comprise non-invasive medical devices with no direct contact with injured skin or mucous membranes and are intended for use on intact skin only.
Gefäßkrankheiten Rhein-Ruhr
Essen, North Rhine-Westphalia, Germany
Dr. Hans-Walter Fiedler
Werl, North Rhine-Westphalia, Germany
Praxis für Innere Medizin und Gefäßkrankheiten
Halle, Saxony-Anhalt, Germany
Dr. med. Jörg Schleinitz Facharzt für Allgemeinmedizin
Lützen, Saxony-Anhalt, Germany
Clinical performance: circumference of the edema
Circumference measurements at selected points of the limb (taken manually using measuring tape) \[cm\]
Time frame: change from baseline after a treatment duration of 7, 14, and 21 days
Clinical performance: edema status
Evaluation of edema (visual inspection and palpitation) according to standardized criteria
Time frame: change from baseline after a treatment duration of 7, 14, and 21 days
Quality of Life assessed by patient questionnaire
extend of restrictions regarding work due to the lymphoedema (indicated on a 5-point scale)
Time frame: assessed before treatment and after 21 days of treatments with JC
Quality of Life assessed by patient questionnaire
extend of restrictions regarding leisure time due to the lymphoedema (indicated on a 5-point scale)
Time frame: assessed before treatment and after 21 days of treatments with JC
Quality of Life assessed by patient questionnaire
extend of restrictions regarding psychological well-being due to the lymphoedema (indicated on a 5-point scale)
Time frame: assessed before treatment and after 21 days of treatments with JC
Patient satisfaction assessed by patient questionnaire
Comparison of patient reported outcomes regarding previously worn compressions garments and JC
Time frame: assessed before treatment and after 21 days of treatments with JC
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.