Back to resultsStudy to Evaluate Made-to-measure Compression Garments
Primary Purpose
Lymphedema
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
JOBST® Confidence compression garments
Sponsored by
About this trial
This is an interventional treatment trial for Lymphedema
Eligibility Criteria
Inclusion Criteria:
- 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)
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Gefäßkrankheiten Rhein-Ruhr
- Dr. Hans-Walter Fiedler
- Praxis für Innere Medizin und Gefäßkrankheiten
- Dr. med. Jörg Schleinitz Facharzt für Allgemeinmedizin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
JOBST® Confidence compression garments
Arm Description
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.
Outcomes
Primary Outcome Measures
Clinical performance: circumference of the edema
Circumference measurements at selected points of the limb (taken manually using measuring tape) [cm]
Clinical performance: edema status
Evaluation of edema (visual inspection and palpitation) according to standardized criteria
Secondary Outcome Measures
Quality of Life assessed by patient questionnaire
extend of restrictions regarding work due to the lymphoedema (indicated on a 5-point scale)
Quality of Life assessed by patient questionnaire
extend of restrictions regarding leisure time due to the lymphoedema (indicated on a 5-point scale)
Quality of Life assessed by patient questionnaire
extend of restrictions regarding psychological well-being due to the lymphoedema (indicated on a 5-point scale)
Patient satisfaction assessed by patient questionnaire
Comparison of patient reported outcomes regarding previously worn compressions garments and JC
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04901962
Brief Title
Study to Evaluate Made-to-measure Compression Garments
Official Title
Prospective Multicentre Study to Evaluate the Clinical Performance and Safety of Innovative, Made-to-measure Compression Garments in Daily Routine
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
December 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BSN Medical GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JOBST® Confidence compression garments
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
JOBST® Confidence compression garments
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical performance: circumference of the edema
Description
Circumference measurements at selected points of the limb (taken manually using measuring tape) [cm]
Time Frame
change from baseline after a treatment duration of 7, 14, and 21 days
Title
Clinical performance: edema status
Description
Evaluation of edema (visual inspection and palpitation) according to standardized criteria
Time Frame
change from baseline after a treatment duration of 7, 14, and 21 days
Secondary Outcome Measure Information:
Title
Quality of Life assessed by patient questionnaire
Description
extend of restrictions regarding work due to the lymphoedema (indicated on a 5-point scale)
Time Frame
assessed before treatment and after 21 days of treatments with JC
Title
Quality of Life assessed by patient questionnaire
Description
extend of restrictions regarding leisure time due to the lymphoedema (indicated on a 5-point scale)
Time Frame
assessed before treatment and after 21 days of treatments with JC
Title
Quality of Life assessed by patient questionnaire
Description
extend of restrictions regarding psychological well-being due to the lymphoedema (indicated on a 5-point scale)
Time Frame
assessed before treatment and after 21 days of treatments with JC
Title
Patient satisfaction assessed by patient questionnaire
Description
Comparison of patient reported outcomes regarding previously worn compressions garments and JC
Time Frame
assessed before treatment and after 21 days of treatments with JC
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Hirsch, Dr. med.
Organizational Affiliation
Praxis für Innere Medizin und Gefäßkrankheiten
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gefäßkrankheiten Rhein-Ruhr
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45131
Country
Germany
Facility Name
Dr. Hans-Walter Fiedler
City
Werl
State/Province
North Rhine-Westphalia
ZIP/Postal Code
59457
Country
Germany
Facility Name
Praxis für Innere Medizin und Gefäßkrankheiten
City
Halle (Saale)
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06108
Country
Germany
Facility Name
Dr. med. Jörg Schleinitz Facharzt für Allgemeinmedizin
City
Lützen
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06686
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate Made-to-measure Compression Garments
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