Study to Evaluate Made-to-measure Compression Garments

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

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.

Study Overview

• Status: Completed
• Conditions: Lymphedema
• Intervention / Treatment: Device: JOBST® Confidence compression garments

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 Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45131
      • Gefäßkrankheiten Rhein-Ruhr
  • North Rhine-Westphalia
    • Werl, North Rhine-Westphalia, Germany, 59457
      • Dr. Hans-Walter Fiedler
  • Sachsen-Anhalt
    • Halle (Saale), Sachsen-Anhalt, Germany, 06108
      • Praxis für Innere Medizin und Gefäßkrankheiten
    • Lützen, Sachsen-Anhalt, Germany, 06686
      • Dr. med. Jörg Schleinitz Facharzt für Allgemeinmedizin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: BSN Medical GmbH
• Investigators: Principal Investigator: Tobias Hirsch, Dr. med., Praxis für Innere Medizin und Gefäßkrankheiten

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Actual): December 22, 2022
• Study Completion (Actual): December 22, 2022

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: C2612

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No