NCT04901962

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: BSN Medical GmbH · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphedema

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-21
• Primary completion: 2022-12-22
• Completion: 2022-12-22
• First posted: 2021-05-26
• Last updated: 2023-01-05

Locations

4 sites across 1 country: Germany