NCT04714476

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

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

• 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 extremities of 36 healthy subjects will be measured by 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	Subjects will wear one of two made-to-measure compression garments: (1) JOBST® Confidence leggins (BT) and (2) JOBST® Confidence Bermuda (ET)

Timeline

• Start date: 2021-02-23
• Primary completion: 2021-03-12
• Completion: 2021-03-12
• First posted: 2021-01-19
• Last updated: 2025-02-05

Locations

1 site across 1 country: Germany