NCT04181580

Feasibility Study Focusing on Fit of Made-to-measure Compression Garments in Healthy Subjects

Explorative, Monocentric, Feasibility Study Focusing on Fit of Innovative, Made-to-measure Compression Garments in Healthy Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: BSN Medical GmbH · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Fit of made-to-measure compression garments in healthy subjects will be tested on one day, simulating daily activities.

Detailed description

Lower and upper extremities of 36 health subjects will be measured be trained experts to collect measures for made-to-measure compression garments. Fit of made-to-measure compression garments, which are not on the market yet, among healthy subjects will be tested on one day, simulating daily activities. Fit will be assessed directly after donning and after a wearing period of maximum 7 hours at the study site by trained experts. Healthy subjects will give back study products at the end of the wearing period. AEs will be documented throughout the study.

Conditions

• Product Use Issue

Interventions

Type	Name	Description
DEVICE	Made-to-measure compression garment	Made-to-measure compression garment

Timeline

• Start date: 2019-11-28
• Primary completion: 2019-12-13
• Completion: 2019-12-13
• First posted: 2019-11-29
• Last updated: 2020-01-18

Locations

1 site across 1 country: Germany