Study to Evaluate Made-to-measure Compression Garments

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Multicentre Study to Evaluate the Clinical Performance and Safety of Innovative, Made-to-measure Compression Garments in Daily Routine

Conditions
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Lymphedema

Intervention / Treatment
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* Device: JOBST® Confidence compression garments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Form Men, women or diverse aged 18 years or up to 70 years with full legal competence Patient is mentally and physically able to participate in the study Capability to understand the subject information and to provide conscious informed consent Capability and willingness to follow protocol requirements 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) Mild to moderate lymphedema of the lower and/or upper extremities (ISL stage I or II) Indication and possibility of treatment with a flat-knitted compression garment during the day Patients who are familiar with wearing compression garments Indicated Complete Decongestive Therapy Phase II (Maintenance phase) Willingness to wear the study product at least 5 days a week for at least 6 hours a day Exclusion Criteria: Pregnant or lactating women or diverse subjects Alcohol abuse (mentioned by the patient and/or suspected by the investigator) Drug abuse (mentioned by the patient and/or suspected by the investigator) Patients who need a different compression class (higher or lower than CCL 2) Pronounced skin folds Pronounced shape distortions cG (lymphatic measure of the thigh) >90 cm for AG stocking Indicated Complete Decongestive Therapy Phase I Known allergy or intolerance to one or more components of the product Advanced arterial insufficiency including ischemia Uncontrolled congestive heart failure Untreated septic phlebitis Phlegmasia coerulea dolens Immobility (confinement to bed). Conditions in which increased venous and lymphatic return is not desired. Weeping dermatosis Cutaneous infections Severely compromised skin sensibility and impaired sensitivity of the limb Advanced peripheral neuropathy Rheumatoid arthritis Complex regional pain syndrome (CRPS, M. Sudeck) Malignant lymphedema Gangrene Sponsors or manufacturers staff Open wounds in the test area Diuretics, except low doses for treatment of hypertension (≤ 12.5 mg Hydrochlorothiazide) Nephrotic syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JOBST® Confidence compression garments<br>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. | Device: JOBST® Confidence compression garments<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |