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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JOBST® Confidence compression garments | Experimental | The CE-marked class I medical devices JOBST® Confidence compression garments for lower and upper extremities will be tested under routine conditions according to their selected intended use. Subjects will be treated with either thigh-high compression stockings (AG) or arm compression garments without hand part (CG1), depending on their indication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JOBST® Confidence compression garments | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical performance: circumference of the edema | Circumference measurements at selected points of the limb (taken manually using measuring tape) [cm] | 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 | change from baseline after a treatment duration of 7, 14, and 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life assessed by patient questionnaire | extend of restrictions regarding work due to the lymphoedema (indicated on a 5-point scale) | assessed before treatment and after 21 days of treatments with JC |
| Quality of Life assessed by patient questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Hirsch, Dr. med. | Praxis für Innere Medizin und Gefäßkrankheiten | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gefäßkrankheiten Rhein-Ruhr | Essen | North Rhine-Westphalia | 45131 | Germany | ||
| Dr. Hans-Walter Fiedler |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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|
extend of restrictions regarding leisure time due to the lymphoedema (indicated on a 5-point scale) |
| 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) | 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 | assessed before treatment and after 21 days of treatments with JC |
| Werl |
| North Rhine-Westphalia |
| 59457 |
| Germany |
| Praxis für Innere Medizin und Gefäßkrankheiten | Halle | Saxony-Anhalt | 06108 | Germany |
| Dr. med. Jörg Schleinitz Facharzt für Allgemeinmedizin | Lützen | Saxony-Anhalt | 06686 | Germany |