Study to Evaluate Made-to-measure Compression Garments

NCT04901962 | Completed

• 1 other identifier: C2612
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 4

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.

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Quality of Life assessed by patient questionnaire

  assessed before treatment and after 21 days of treatments with JC

• Quality of Life assessed by patient questionnaire

  assessed before treatment and after 21 days of treatments with JC

• Quality of Life assessed by patient questionnaire

  assessed before treatment and after 21 days of treatments with JC

• Patient satisfaction assessed by patient questionnaire

  assessed before treatment and after 21 days of treatments with JC

Study Arms (1)

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.

Device: JOBST® Confidence compression garments

Interventions

JOBST® Confidence compression garments DEVICE

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.

JOBST® Confidence compression garments

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• BSN Medical GmbH: lead

Study Sites (4)

Gefäßkrankheiten Rhein-Ruhr

Essen, North Rhine-Westphalia, 45131, Germany

Location

Dr. Hans-Walter Fiedler

Werl, North Rhine-Westphalia, 59457, Germany

Location

Praxis für Innere Medizin und Gefäßkrankheiten

Halle, Saxony-Anhalt, 06108, Germany

Location

Dr. med. Jörg Schleinitz Facharzt für Allgemeinmedizin

Lützen, Saxony-Anhalt, 06686, Germany

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Tobias Hirsch, Dr. med.

  Praxis für Innere Medizin und Gefäßkrankheiten

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 26, 2021
• Study Start: July 21, 2021
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: January 5, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)