Study to Evaluate Made-to-measure Compression Garments

Lymphedema Clinical Trial

Official title:

Prospective Multicentre Study to Evaluate the Clinical Performance and Safety of Innovative, Made-to-measure Compression Garments in Daily Routine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04901962
• Other study ID #: C2612
• Status: Completed
• Phase: N/A
• Start date: July 21, 2021
• Est. completion date: December 22, 2022

Study information

• Verified date: February 2022
• Source: BSN Medical GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 22, 2022
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphedema

Intervention

Device:
• JOBST® Confidence compression garments
JOBST® Confidence (JC) compression garments will be used for daytime treatment of leg or arm lymphedema. JC compression garments exert a specific therapeutic external, physical compression level and are therefore intended to use for the management of edema. JC comprise non-invasive medical devices with no direct contact with injured skin or mucous membranes and are intended for use on intact skin only.

Locations

Country	Name	City	State
Germany	Gefäßkrankheiten Rhein-Ruhr	Essen	Nordrhein-Westfalen
Germany	Praxis für Innere Medizin und Gefäßkrankheiten	Halle (Saale)	Sachsen-Anhalt
Germany	Dr. med. Jörg Schleinitz Facharzt für Allgemeinmedizin	Lützen	Sachsen-Anhalt
Germany	Dr. Hans-Walter Fiedler	Werl	North Rhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
BSN Medical GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performance: circumference of the edema	Circumference measurements at selected points of the limb (taken manually using measuring tape) [cm]	change from baseline after a treatment duration of 7, 14, and 21 days
Primary	Clinical performance: edema status	Evaluation of edema (visual inspection and palpitation) according to standardized criteria	change from baseline after a treatment duration of 7, 14, and 21 days
Secondary	Quality of Life assessed by patient questionnaire	extend of restrictions regarding work due to the lymphoedema (indicated on a 5-point scale)	assessed before treatment and after 21 days of treatments with JC
Secondary	Quality of Life assessed by patient questionnaire	extend of restrictions regarding leisure time due to the lymphoedema (indicated on a 5-point scale)	assessed before treatment and after 21 days of treatments with JC
Secondary	Quality of Life assessed by patient questionnaire	extend of restrictions regarding psychological well-being due to the lymphoedema (indicated on a 5-point scale)	assessed before treatment and after 21 days of treatments with JC
Secondary	Patient satisfaction assessed by patient questionnaire	Comparison of patient reported outcomes regarding previously worn compressions garments and JC	assessed before treatment and after 21 days of treatments with JC