Status:
COMPLETED
Study to Evaluate Made-to-measure Compression Garments
Lead Sponsor:
BSN Medical GmbH
Conditions:
Lymphedema
Eligibility:
All Genders
18-70 years
Phase:
NA
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...
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 previous...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2022
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT04901962
Start Date
July 21 2021
End Date
December 22 2022
Last Update
January 5 2023
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Gefäßkrankheiten Rhein-Ruhr
Essen, North Rhine-Westphalia, Germany, 45131
2
Dr. Hans-Walter Fiedler
Werl, North Rhine-Westphalia, Germany, 59457
3
Praxis für Innere Medizin und Gefäßkrankheiten
Halle, Saxony-Anhalt, Germany, 06108
4
Dr. med. Jörg Schleinitz Facharzt für Allgemeinmedizin
Lützen, Saxony-Anhalt, Germany, 06686