Clinical trial NCT04901962: Study to Evaluate Made-to-measure Compression Garments
Official title: Prospective Multicentre Study to Evaluate the Clinical Performance and Safety of Innovative, Made-to-measure Compression Garments in Daily Routine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Lead sponsor: BSN Medical GmbH
Sponsor class: INDUSTRY
First posted: 2021-05-26
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical performance: circumference of the edema
timeFrame: change from baseline after a treatment duration of 7, 14, and 21 days
measure: Clinical performance: edema status
timeFrame: change from baseline after a treatment duration of 7, 14, and 21 days
Secondary outcomes:
measure: Quality of Life assessed by patient questionnaire
timeFrame: assessed before treatment and after 21 days of treatments with JC
measure: Quality of Life assessed by patient questionnaire
timeFrame: assessed before treatment and after 21 days of treatments with JC
measure: Quality of Life assessed by patient questionnaire
timeFrame: assessed before treatment and after 21 days of treatments with JC
measure: Patient satisfaction assessed by patient questionnaire
timeFrame: assessed before treatment and after 21 days of treatments with JC
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Gefäßkrankheiten Rhein-Ruhr
state: Nordrhein-Westfalen
city: Werl
country: Germany
facility: Dr. Hans-Walter Fiedler
state: North Rhine-Westphalia
city: Halle (Saale)
country: Germany
facility: Praxis für Innere Medizin und Gefäßkrankheiten
state: Sachsen-Anhalt
city: Lützen
country: Germany
facility: Dr. med. Jörg Schleinitz Facharzt für Allgemeinmedizin
state: Sachsen-Anhalt
Study officials:
affiliation: Praxis für Innere Medizin und Gefäßkrankheiten
name: Tobias Hirsch, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: