LymphedemaNCT04901962
Study to Evaluate Made-to-measure Compression Garments
A study testing JOBST® Confidence compression garments in people with Lymphedema, run by BSN Medical GmbH at 4 sites in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymphedema
- What is being tested?
- JOBST® Confidence compression garments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 4 sitesGermany
- Study dates
- 21 Jul 2021to 22 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- Men, women or diverse aged 18 years or up to 70 years with full legal competence
- Patient is mentally and physically able to participate in the study
- Capability to understand the subject information and to provide conscious informed consent
- Capability and willingness to follow protocol requirements
- 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)
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- Mild to moderate lymphedema of the lower and/or upper extremities (ISL stage I or II)
- Indication and possibility of treatment with a flat-knitted compression garment during the day
- Patients who are familiar with wearing compression garments
- Indicated Complete Decongestive Therapy Phase II (Maintenance phase)
- Willingness to wear the study product at least 5 days a week for at least 6 hours a day
Who cannot join
- Pregnant or lactating women or diverse subjects
- Alcohol abuse (mentioned by the patient and/or suspected by the investigator)
- Drug abuse (mentioned by the patient and/or suspected by the investigator)
- Patients who need a different compression class (higher or lower than CCL 2)
- Pronounced skin folds
- Pronounced shape distortions
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- cG (lymphatic measure of the thigh) >90 cm for AG stocking
- Indicated Complete Decongestive Therapy Phase I
- Known allergy or intolerance to one or more components of the product
- Advanced arterial insufficiency including ischemia
- Uncontrolled congestive heart failure
- Untreated septic phlebitis
- Phlegmasia coerulea dolens
- Immobility (confinement to bed).
- Conditions in which increased venous and lymphatic return is not desired.
- Weeping dermatosis
- Cutaneous infections
- Severely compromised skin sensibility and impaired sensitivity of the limb
- Advanced peripheral neuropathy
- Rheumatoid arthritis
- Complex regional pain syndrome (CRPS, M. Sudeck)
- Malignant lymphedema
- Gangrene
- Sponsors or manufacturers staff
- Open wounds in the test area
- Diuretics, except low doses for treatment of hypertension (≤ 12.5 mg Hydrochlorothiazide)
- Nephrotic syndrome
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Gefäßkrankheiten Rhein-Ruhr
Essen, North Rhine-Westphalia, 45131
Praxis für Innere Medizin und Gefäßkrankheiten
Halle, Saxony-Anhalt, 06108
Dr. med. Jörg Schleinitz Facharzt für Allgemeinmedizin
Lützen, Saxony-Anhalt, 06686
Dr. Hans-Walter Fiedler
Werl, North Rhine-Westphalia, 59457
About this study
Official title: 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.
Read the 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.
- Conditions
- Lymphedema
- Being tested
- JOBST® Confidence compression garments
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JOBST® Confidence compression garmentsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| JOBST® Confidence compression garments | Experimental | 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. Receives: Device: JOBST® Confidence compression garments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance: circumference of the edema
Circumference measurements at selected points of the limb (taken manually using measuring tape) [cm]
Measured: 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
Measured: change from baseline after a treatment duration of 7, 14, and 21 days
Secondary outcomes (4)
Quality of Life assessed by patient questionnaire
extend of restrictions regarding work due to the lymphoedema (indicated on a 5-point scale)
Measured: 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)
Measured: 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)
Measured: 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
Measured: assessed before treatment and after 21 days of treatments with JC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start21 Jul 2021
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- BSN Medical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tobias Hirsch, Dr. med., Principal investigator, Praxis für Innere Medizin und Gefäßkrankheiten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901962
- Sponsor's protocol ID
- C2612
- Status last verified
- Feb 2022
- First submitted
- 17 May 2021
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentre Study to Evaluate the Clinical Performance and Safety of Innovative, Made-to-measure Compression Garments in Daily Routine
- ClinicalTrials.gov ID
- NCT04901962
- Acronym / sponsor ID
- C2612
- Conditions
- Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- BSN Medical GmbHIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JOBST® Confidence compression garments | Experimental | Device: JOBST® Confidence compression garmentsThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed Informed Consent Form
- Men, women or diverse aged 18 years or up to 70 years with full legal competence
- Patient is mentally and physically able to participate in the study
- Capability to understand the subject information and to provide conscious informed consent
- Capability and willingness to follow protocol requirements
Key exclusion criteria (27 listed)
- Pregnant or lactating women or diverse subjects
- Alcohol abuse (mentioned by the patient and/or suspected by the investigator)
- Drug abuse (mentioned by the patient and/or suspected by the investigator)
- Patients who need a different compression class (higher or lower than CCL 2)
- Pronounced skin folds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JOBST® Confidence compression garmentsJOBST® 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. | Device | JOBST® Confidence compression garments |
Primary outcome
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]
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
4 secondary outcomes
Quality of Life assessed by patient questionnaire
Time frame: 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
Quality of Life assessed by patient questionnaire
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Hirsch, Dr. med. principal investigator
Praxis für Innere Medizin und Gefäßkrankheiten
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JOBST® Confidence compression garments in people with Lymphedema, run by BSN Medical GmbH at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance: circumference of the edema (time frame: change from baseline after a treatment duration of 7, 14, and 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.