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

University of Zurich (UZH)

Status and phase: Completed; Phase 4

Conditions: Venous Insufficiency

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02621632

KEK-ZH-Nr. 2013-091

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Healthy subjects and patients

Other group

Description:

To done a novel compression system. 20 healthy subjects and 20 patients done a novel compression system termed Socknleg and a compression class III stocking as a comparator.The Socknleg compression system was developed by the investigator and produced by Sigvaris AG, St. Gallen, Switzerland.

Treatment:

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