3D Foot Scanner Reliability for Footwear Fit and Design

Diabetes Complications Clinical Trial

Official title:

Reliability of 3D Foot Scanner for Use in Diabetes Fit Evaluation and Footwear Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05676619
• Other study ID #: 0865
• Status: Completed
• Phase: N/A
• Start date: February 16, 2023
• Est. completion date: April 14, 2024

Study information

• Verified date: May 2023
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 14, 2024
• Est. primary completion date: April 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Complications

Intervention

Device:
• 3D foot scanner
Reliability of 3D foot scanner during repeated scans

Locations

Country	Name	City	State
United Kingdom	Leicester General Hospital	Leicester

Sponsors (2)

Lead Sponsor	Collaborator
University of Leicester	University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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