3D Foot Scanner Reliability for Footwear Fit and Design | NCT05676619

Studies
3D Foot Scanner Reliability for Footwear Fit and Design

NCT05676619

Sponsor

University of Leicester

Status

Completed

Last Update Posted

May 8, 2024Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Diabetes Complications

Interventions

3D foot scanner

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 16, 2023Actual

Primary Completion Date

Apr 14, 2024Actual

Completion Date

Apr 14, 2024Actual

First Submitted Date

Dec 19, 2022

First Submission Date that Met QC Criteria

Jan 4, 2023

First Posted Date

Jan 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2024

Last Update Posted Date

May 8, 2024Actual

Name	Class
University Hospitals, Leicester	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators will carry out a proof-of-concept study in 20 adult healthy male and female volunteers in order to: assess a 3D foot scanner's reliability. Specifically, the investigators will assess its variability during repeated foot scans of the same subject's foot. Three repeated foot scans will be carried out by two different examiners to measure intrarater and interrater reliability (Intraclass Correlation Coefficient

Detailed Description

Evidence of reliability is essential for use of a 3D foot scanner in diabetes footwear fit evaluation and orthopaedic footwear design. The investigators will carry out a proof-of-concept study in 20 healthy adult male and female volunteers in order to: assess the 3D foot scanner's reliability. Specifically, the investigators will assess its variability during three repeated foot scans of the same subject's foot. Three half weightbearing foot scans will be carried out by two different examiners to measure intrarater and interrater reliability (Intraclass Correlation Coefficient).

The investigators will carry out a proof-of-concept study in 20 healthy adult male and female volunteers (10 each) in order to assess the Elinvision 3D foot scanner's (i) intra-rater reliability through repeated foot scans (3 times each) and (ii) inter-rater reliability of these scans as carried out by two independent examiners whilst participants are half weightbearing to establish adequate reliability (0.80+ ICC) for use in subsequent diabetes footwear fit assessment and orthopaedic footwear design and manufacture.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single cohort of healthy volunteers	Other	Single cohort of healthy volunteers	Device: 3D foot scanner

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3D foot scanner	Device	Reliability of 3D foot scanner during repeated scans	Single cohort of healthy volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intrarater reliability (Intraclass Correlation Coefficient) of 3D foot scans repeated at baseline (change)	(i) Intrarater reliability (Intraclass Correlation Coefficient) based on three scans of the same subject's foot whilst half-weightbearing carried out by the same 'rater' i.e. person using the 3D foot scanner;	Repeated scans at baseline
Interrater reliability (Intraclass Correlation Coefficient) of 3D foot scans repeated at baseline (change)	(ii) Interrater reliability (Intraclass Correlation Coefficient) based on three scans of the same subject's foot first by one rater (as above) and then by a second rater	Repeated scans at baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy men and women aged 18 years or over
Able to walk unaided
Able to walk up steps (the 3D scanner requires a small step on to the device to enter the correct position for measurement)
Willingness and capacity to participate in the study and to sign the informed consent form

Exclusion Criteria:

Diabetes mellitus diagnosis
Inability to ambulate independently without walking aids
No obvious foot deformities
No history of foot surgery
No pain, injuries or medical conditions affecting the legs or lower back
Any issues around balance (participants must remain standing in position for the approximately fifteen seconds required to obtain the 3D scan of their feet)
Health conditions that impact foot morphology

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Petra J Jones	University Hospitals, Leicester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leicester General Hospital		Leicester		LE5 4PW	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

There is no plan to make individual participant data (IPD) available to other researchers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D048909	Diabetes Complications

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D004700	Endocrine System Diseases

Browse Leaves

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Browse Branches

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