NCT02621632

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

1.8 years

First QC Date

May 22, 2015

Last Update Submit

December 1, 2015

Conditions

Venous Insufficiency

Keywords

Compression therapy

Outcome Measures

Primary Outcomes (1)

  • Donning success.

    Ability to fully done the investigated compression devices.

    Successful donning has to be completed within 5 minutes.

Secondary Outcomes (1)

  • Interface pressure

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

Study Arms (1)

Healthy subjects and patients

OTHER

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.

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

Interventions

(Socknleg)To done of a novel compression systemDEVICE

To done a novel compression system.

Healthy subjects and patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Active venous ulcer
  • Peripheral arterial disease
  • Peripheral neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, University Hospital of Zurich, Switzerland

Zurich, Canton of Zurich, CH-8091, Switzerland

Location

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Juerg Hafner, Prof. (MD)

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2015

First Posted

December 3, 2015

Study Start

March 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

CH(1)