Study to Evaluate Made-to-measure Compression Garments

Not Applicable

Completed

• Conditions: Lymphedema
• Interventions: Device: JOBST® Confidence compression garments

• Registration Number: NCT04901962
• Lead Sponsor: BSN Medical GmbH

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.

Study Timeline

• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-26
• Study Start: 2021-07-21
• Status Verified: 2022-02
• Primary Completion: 2022-12-22
• Study Completion: 2022-12-22
• Last Update Submitted: 2023-01-04
• Last Update Posted: 2023-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JOBST® Confidence compression garments	JOBST® Confidence compression garments	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.

Primary Outcome Measures

Name	Time	Method
Clinical performance: circumference of the edema	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	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 Outcome Measures

Name	Time	Method
Patient satisfaction assessed by patient questionnaire	assessed before treatment and after 21 days of treatments with JC	Comparison of patient reported outcomes regarding previously worn compressions garments and JC
Quality of Life assessed by patient questionnaire	assessed before treatment and after 21 days of treatments with JC	extend of restrictions regarding psychological well-being due to the lymphoedema (indicated on a 5-point scale)

Trial Locations

Locations (4)

Praxis für Innere Medizin und Gefäßkrankheiten; 🇩🇪 Halle (Saale), Sachsen-Anhalt, Germany

Gefäßkrankheiten Rhein-Ruhr; 🇩🇪 Essen, Nordrhein-Westfalen, Germany

Dr. med. Jörg Schleinitz Facharzt für Allgemeinmedizin; 🇩🇪 Lützen, Sachsen-Anhalt, Germany

Dr. Hans-Walter Fiedler; 🇩🇪 Werl, North Rhine-Westphalia, Germany