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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02621632
Acronym
Socknleg
Enrollment
40
Registered
2015-12-03
Start date
2013-03-31
Completion date
2014-12-31
Last updated
2015-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Insufficiency

Keywords

Compression therapy

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.

Interventions

DEVICE(Socknleg)To done of a novel compression system

To done a novel compression system.

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

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

Design outcomes

Primary

MeasureTime frameDescription
Donning success.Successful donning has to be completed within 5 minutes.Ability to fully done the investigated compression devices.

Secondary

MeasureTime frameDescription
Interface pressureInterface pressure is measured within 5 minutes of complete donning of the stocking.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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026