NCT03329430

Brief Summary

The purpose of the research is to compare the influence of customized foot orthoses use on the venous status among healthy female and male subjects. This is a quasi-experimental study which included 20 healthy subjects. Sociodemographic and medical record data are registered. Furthermore,venous function is evaluated by plethysmography, first, without orthoses and, after 20 days, with orthoses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

October 30, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

November 5, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2017

Completed
Last Updated

December 11, 2017

Status Verified

December 1, 2017

Enrollment Period

1 month

First QC Date

October 30, 2017

Last Update Submit

December 8, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Venous filling time

    Seconds

    Change from Baseline venous filling time at 1 month

Study Arms (1)

Foot orthoses

EXPERIMENTAL

Customize foot orthoses

Other: Foot orthoses

Interventions

Customized foot orthoses

Foot orthoses

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects.

You may not qualify if:

  • Prior diagnosed conditions such as neurological, vascular or traumatic disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior de Saúde do Vale do Ave

Vila Nova de Famalicão, Vila Nova de Famalicão, 4760-409, Portugal

Location

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MSc, PT

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 6, 2017

Study Start

November 5, 2017

Primary Completion

December 6, 2017

Study Completion

December 6, 2017

Last Updated

December 11, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations