Lymphedema
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEJOBST® Confidence compression garments
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.
Sponsors
BSN Medical GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Signed Informed Consent Form 2. Men, women or diverse aged 18 years or up to 70 years with full legal competence 3. Patient is mentally and physically able to participate in the study 4. Capability to understand the subject information and to provide conscious informed consent 5. Capability and willingness to follow protocol requirements 6. All female or diverse subjects of childbearing potential must agree to use a reliable method of contraception with a Pearl-Index of less than 1% per year when used consistently and correctly\* (\*such as hormone implants,injectables, combined oral contraceptives (combined gestagen-estrogen pills), some intra uterine devices (IUDs), surgically sterility (hysterectomy or tubal ligation), sexual abstinence or vasectomized partner for at least 4 weeks) 7. Mild to moderate lymphedema of the lower and/or upper extremities (ISL stage I or II) 8. Indication and possibility of treatment with a flat-knitted compression garment during the day 9. Patients who are familiar with wearing compression garments 10. Indicated Complete Decongestive Therapy Phase II (Maintenance phase) 11. Willingness to wear the study product at least 5 days a week for at least 6 hours a day
Exclusion criteria
1. Pregnant or lactating women or diverse subjects 2. Alcohol abuse (mentioned by the patient and/or suspected by the investigator) 3. Drug abuse (mentioned by the patient and/or suspected by the investigator) 4. Patients who need a different compression class (higher or lower than CCL 2) 5. Pronounced skin folds 6. Pronounced shape distortions 7. cG (lymphatic measure of the thigh) \>90 cm for AG stocking 8. Indicated Complete Decongestive Therapy Phase I 9. Known allergy or intolerance to one or more components of the product 10. Advanced arterial insufficiency including ischemia 11. Uncontrolled congestive heart failure 12. Untreated septic phlebitis 13. Phlegmasia coerulea dolens 14. Immobility (confinement to bed). 15. Conditions in which increased venous and lymphatic return is not desired. 16. Weeping dermatosis 17. Cutaneous infections 18. Severely compromised skin sensibility and impaired sensitivity of the limb 19. Advanced peripheral neuropathy 20. Rheumatoid arthritis 21. Complex regional pain syndrome (CRPS, M. Sudeck) 22. Malignant lymphedema 23. Gangrene 24. Sponsors or manufacturers staff 25. Open wounds in the test area 26. Diuretics, except low doses for treatment of hypertension (≤ 12.5 mg Hydrochlorothiazide) 27. Nephrotic syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical performance: circumference of the edema | change from baseline after a treatment duration of 7, 14, and 21 days | Circumference measurements at selected points of the limb (taken manually using measuring tape) \[cm\] |
| Clinical performance: edema status | change from baseline after a treatment duration of 7, 14, and 21 days | Evaluation of edema (visual inspection and palpitation) according to standardized criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life assessed by patient questionnaire | assessed before treatment and after 21 days of treatments with JC | extend of restrictions regarding work due to the lymphoedema (indicated on a 5-point scale) |
| Patient satisfaction assessed by patient questionnaire | assessed before treatment and after 21 days of treatments with JC | Comparison of patient reported outcomes regarding previously worn compressions garments and JC |
Countries
Germany
Outcome results
None listed