Study to Evaluate Made-to-measure Compression Garments

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.

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