Back to resultsCustom Foot Orthoses & Venous Status
Primary Purpose
Foot, Foot Orthoses, Photoplethysmography
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Foot orthoses
Sponsored by
About this trial
This is an interventional treatment trial for Foot
Eligibility Criteria
Inclusion Criteria:
- Healthy subjects.
Exclusion Criteria:
- Prior diagnosed conditions such as neurological, vascular or traumatic disorders.
Sites / Locations
- Escola Superior de Saúde do Vale do Ave
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Foot orthoses
Arm Description
Customize foot orthoses
Outcomes
Primary Outcome Measures
Venous filling time
Seconds
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03329430
Brief Title
Custom Foot Orthoses & Venous Status
Official Title
Influence of Custom Foot Orthoses on Venous Status
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 5, 2017 (Actual)
Primary Completion Date
December 6, 2017 (Actual)
Study Completion Date
December 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de León
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot, Foot Orthoses, Photoplethysmography, Venous Stasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Foot orthoses
Arm Type
Experimental
Arm Description
Customize foot orthoses
Intervention Type
Other
Intervention Name(s)
Foot orthoses
Intervention Description
Customized foot orthoses
Primary Outcome Measure Information:
Title
Venous filling time
Description
Seconds
Time Frame
Change from Baseline venous filling time at 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subjects.
Exclusion Criteria:
Prior diagnosed conditions such as neurological, vascular or traumatic disorders.
Facility Information:
Facility Name
Escola Superior de Saúde do Vale do Ave
City
Vila Nova de Famalicão
State/Province
Vila Nova De Famalicão
ZIP/Postal Code
4760-409
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Custom Foot Orthoses & Venous Status
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