Prospective Multicentre Study to Evaluate the Clinical Performance and Safety of Innovative, Made-to-measure Compression Garments in Daily Routine
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lymphedema
- Sponsor
- BSN Medical GmbH
- Enrollment
- 99
- Locations
- 4
- Primary Endpoint
- Clinical performance: circumference of the edema
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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)
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
Outcomes
Primary Outcomes
Clinical performance: circumference of the edema
Time Frame: 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
Time Frame: 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 Outcomes
- Patient satisfaction assessed by patient questionnaire(assessed before treatment and after 21 days of treatments with JC)
- Quality of Life assessed by patient questionnaire(assessed before treatment and after 21 days of treatments with JC)