NCT03429959: SOCKNLEGZH

SOCKNLEG Compression Stocking Kit : User Friendliness

Completed NA Last updated 27 June 2019

What this trial tests

NA trial testing SOCKNLEG in Venous Insufficiency of Leg in 47 participants. Completed in 30 June 2018.

Timeline

10 January 2018

Primary endpoint
30 June 2018

30 June 2018

Quick facts

Lead sponsor	University of Zurich
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	47
Start date	10 January 2018
Primary completion	30 June 2018
Estimated completion	30 June 2018
Sites	1 location across Switzerland

Drugs / interventions tested

• SOCKNLEG
• SIGVARIS Cotton

Conditions studied

• Venous Insufficiency of Leg — all drugs for Venous Insufficiency of Leg →

Sponsor

University of Zurich

Who can join

65 and older, any sex, with Venous Insufficiency of Leg. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Graduated compression stockings for the initial treatment of varicose veins in people without venous ulceration.
   Knight Nee Shingler SL, Robertson L, Stewart M. · · 2021 · cited 9× · PMID 34271595 · DOI 10.1002/14651858.cd008819.pub4