NCT03429959

SOCKNLEG Compression Stocking Kit : User Friendliness

SOCKNLEG Compression Stocking Kit User Friendliness: Donning-Doffing-Edema Prevention An Open Monocentric Randomized Controlled Cross-over Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The investigators aim to evaluate the user friendliness of a newly designed leg compression stocking kit, the SOCKNLEG, compared to a standard leg compression stocking of the same compression strength, the SIGVARIS Cotton. The SOCKNLEG is not yet commercially available, whereas the SIGVARIS Cotton has been successfully commercialized for many years. After an initial screening visit, a computer generated list will allocate the participants in either the SOCKNLEG or the SIGVARIS Cotton group. All participants will try on both study stockings, in the order of their allocated group, and will rate their donning and doffing success with a questionnaire. The patients will then wear only the assigned study stocking of their allocated group, for a day and rate its comfort again at the end of the day. The donning and doffing success will also be rated by the study investigator. Leg volume measurements of the study leg will be taken at each visit to determine edema prevention.

Conditions

• Venous Insufficiency of Leg

Interventions

Type	Name	Description
DEVICE	SOCKNLEG	Donning and doffing success compared with the two study stockings, wearing the assigned study stocking for a day, Patient Quesationnaire on donning and doffing success and wearing comfort of each study stocking
DEVICE	SIGVARIS Cotton	SIGVARIS Cotton

Timeline

• Start date: 2018-01-10
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2018-02-12
• Last updated: 2019-06-27

Locations

1 site across 1 country: Switzerland