SocknLeg - a User Friendly Medical Compression Study of a Modified Application of a Medical Device
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Zurich
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Donning success.
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Donning success.
Time Frame: Successful donning has to be completed within 5 minutes.
Ability to fully done the investigated compression devices.
Secondary Outcomes
- Interface pressure(Interface pressure is measured within 5 minutes of complete donning of the stocking.)