MedTrace Logo

SOCKNLEG Compression Stocking Kit : User Friendliness

NCT03429959 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2019-06-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Juerg Hafner, Prof. · Department of Dermatology, University Hospital Zurich, Zurich, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-10
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03429959 on ClinicalTrials.gov