SocknLeg - a User Friendly Medical Compression Study of a Modified Application of a Medical Device

Venous Insufficiency Clinical Trial

— Socknleg  

Official title:

SocknLeg - a User Friendly Medical Compression Study of a Modified Application of a Medical Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621632
• Other study ID #: KEK-ZH-Nr. 2013-091
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2015
• Last updated: December 1, 2015
• Start date: March 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The study intends to investigate a novel compression system termed Socknleg composed of an understocking covering the foot with three added stockings extending from the ankle to the knee without covering the foot. The novel Socknleg system is compared to a standard class III compression stocking.

Description:

The investigator tests a novel compression system termed Socknleg in 20 healthy individuals and 20 patients with chronic venous disease. Socknleg is composed of an understocking covering the foot with three added stockings extending from the ankle to the knee without covering the foot. The novel Socknleg system is compared to a standard class III compression stocking. Outcome measures are successful donning and the comparison of interface pressure measured on the level of the ankle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Healthy volunteers: age > 18 years, proband information read, consent form signed

• Patients: age > 18 years, chronic venous insufficiency CEAP C5 (healed venous ulcer).Age > 18 year, patient information read, consent signed.

Exclusion Criteria:

• Active venous ulcer

• Peripheral arterial disease

• Peripheral neuropathy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Venous Insufficiency

Intervention

Device:
• (Socknleg)To done of a novel compression system
To done a novel compression system.

Locations

Country	Name	City	State
Switzerland	Department of Dermatology, University Hospital of Zurich, Switzerland	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Donning success.	Ability to fully done the investigated compression devices.	Successful donning has to be completed within 5 minutes.	No
Secondary	Interface pressure	Interface pressure of the compression systems is measured at level cB1 (transition of the Achilles tendon to the calf muscle) in mmHg by a pressure measuring device termed Picopress® . Interface pressure is compared between the novel compression system and the comparator, a class III compression stocking.	Interface pressure is measured within 5 minutes of complete donning of the stocking.	No