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

NCT ID: NCT02621632

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Venous Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Healthy subjects and patients

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.

Group Type OTHER

(Socknleg)To done of a novel compression system

Intervention Type DEVICE

To done a novel compression system.

Interventions

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(Socknleg)To done of a novel compression system

To done a novel compression system.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juerg Hafner, Prof. (MD)

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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Department of Dermatology, University Hospital of Zurich, Switzerland

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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KEK-ZH-Nr. 2013-091

Identifier Type: -

Identifier Source: org_study_id