Study to Evaluate Made-to-measure Compression Garments

January 4, 2023 updated by: BSN Medical GmbH

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical performance: circumference of the edema
Time Frame: 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]
change from baseline after a treatment duration of 7, 14, and 21 days
Clinical performance: edema status
Time Frame: change from baseline after a treatment duration of 7, 14, and 21 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life assessed by patient questionnaire
Time Frame: assessed before treatment and after 21 days of treatments with JC
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
Time Frame: assessed before treatment and after 21 days of treatments with JC
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
Time Frame: 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)
assessed before treatment and after 21 days of treatments with JC
Patient satisfaction assessed by patient questionnaire
Time Frame: assessed before treatment and after 21 days of treatments with JC
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BSN Medical GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tobias Hirsch, Dr. med., Praxis für Innere Medizin und Gefäßkrankheiten

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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