Comparing Clinical Outcomes Using Two Insole Manufacture Techniques

Comparing the Effectiveness of Computer-aided-design Computer-aided-manufacture (CAD/CAM) Insoles Manufactured From Foam-box Cast vs Direct Scan on Patient Reported Outcome Measures: A Double-blinded, Randomised Controlled Trial

The main purpose of this study is to find out if scanning the foot using a 3D scanner influences the effectiveness of custom made insoles, compared to the more traditional approach of taking a foam-box impression cast of the foot. Both of these methods are currently used as standard care in the NHS Greater Glasgow and Clyde (GGC) Orthotic Department. In this study, insoles will be manufactured either from a direct 3D scan of the foot, or from a foam-box impression cast, and a series of questionnaires will be used to measure any changes in foot pain and foot function. The results from this study will be used to develop an information resource for both patients and Orthotists which will fill gaps in our current knowledge and hopefully guide us further in providing the best possible care for future patients who require insoles.

Study Overview

• Status: Completed
• Conditions: Foot Ankle Injuries; Foot Injury; Foot Deformity; Foot Sprain; Feet, Flat
• Intervention / Treatment: Device: CAD/CAM insoles

Detailed Description

A single centre, double blinded, randomised controlled trial. Interventional, equivalence Trial design.

Participants will be asked to attend 2 face-to-face appointments for assessing and fitting of insoles, which is standard practice in the NHS GGC Orthotic Department. Each face-to-face appointment will take approximately 40 minutes. Following the fitting of the insoles, participants will be asked to participate in 3 telephone calls over 12-weeks, during which they will be asked to answer questions from two questionnaires (the "Foot Health Status Questionnaire", and the "Orthotic and Prosthetic User Survey"). Each telephone appointment will take approximately 15 minutes. Once participants receive their insoles, they will also be asked to keep a diary detailing the number of hours that they wore the insoles each day over 12-weeks. This information will be collected by the Orthotist involved with the trial during the telephone review appointments.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G4 0SF
    • Orthotics Department, Glasgow Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Are aged 18 years or above
• Are referred to the NHS GGC Orthotic service requiring a new assessment for insoles
• are deemed suitable for CAD/CAM insoles as assessed by the PI or Co-I on clinical assessment
• Are able to commit to five appointments over a 16-week period (two Face-to-Face appointments, three Telephone Appointments)
• Have suitable own footwear that can accommodate a CAD/CAM insole as assessed by the PI or Co-I, and as per standard practice can wear these for 12-weeks
• Is willing to allow their General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
• An adequate understanding of written and verbal information in English in order to provide informed consent and answer the study questionnaires

Exclusion Criteria:

• Scheduled elective surgery or other procedures which is likely to affect mobility during the trial.
• Scheduled steroid injection of the foot or ankle up to 3 months prior to joining the trial, or during participation in the trial
• Age <18 years
• Adult with Incapacity, under The Adults with Incapacity (Scotland) Act 2000
• Participant unable or unwilling to consent
• Medial longitudinal Arch height of the foot exceeds depth of EVA blank (35mm)
• Clinical assessment concludes that the participant requires an insole material other than EVA
• Clinical assessment concludes that the participant does not require or will be unlikely to benefit from CAD/CAM insoles.
• The participant is unable to commit to the trial conditions.
• Peripheral Neuropathy present
• Active foot ulceration present
• Participant with life expectancy of less than 6 months.
• Any other significant disease or disorder which, in the opinion of the PI or Co-I, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
• Participants who have participated in another research trial involving an investigational foot orthosis in the past 12 weeks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: insoles manufactured from foam-box cast; Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.	Device: CAD/CAM insoles; computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
Active Comparator: insoles manufactured from direct 3D scan; Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.	Device: CAD/CAM insoles; computer-aided-design computer-aided-manufacture (CAD/CAM) insoles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain	To compare the changes in pain in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.	Measured 4 times throughout the 12-week period that the participant is wearing the insoles: Baseline immediately after receiving intervention (insoles). 4 weeks after intervention. 8 weeks after intervention. And 12 weeks after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot Health Status Questionnaire (FHSQ) - Function Sub-domain	To compare the changes in foot function in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.	Measured 4 times throughout the 12-week period that the participant is wearing the insoles: Baseline immediately after receiving intervention (insoles). 4 weeks after intervention. 8 weeks after intervention. And 12 weeks after intervention
Foot Health Status Questionnaire - Foot Health Sub-domain	To compare the changes in foot health in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.	Measured 4 times throughout the 12-week period that the participant is wearing the insoles: Baseline immediately after receiving intervention (insoles). 4 weeks after intervention. 8 weeks after intervention. And 12 weeks after intervention
Orthotic and Prosthetic User Survey9-12 (Satisfaction With Device Survey)	To compare the patient satisfaction in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.	Measured 12 weeks after being fitted with insoles
Differential Cost Analysis	A differential cost analysis was undertaken. This involved calculating the total cost for each participant using a calculation of transit costs, staff time, and physical resources for each participant throughout their time in the trial.	Costs were calculated per participant from baseline until their completion of the trial at week 12.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tertiary Outcome Measure - Hours of Insole Wear Time Per Day	Patients will keep a diary of daily wear time in hours, in accordance with prior publications on measuring Orthotic Adherence. The minimum threshold for adherence is >21 hours per week	Measured from baseline until completion of the trial at week 12
Tertiary Outcome Measure - Dropout Rate	Dropout rate = n dropout at end of trial	Measured from baseline to completion of the trial at 12 weeks, for each participant

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: University of Central Lancashire
• Investigators: Principal Investigator: Graham Chapman, University of Central Lancashire

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2022
• Primary Completion (Actual): November 24, 2023
• Study Completion (Actual): November 24, 2023

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Talipes; Musculoskeletal Diseases; Leg Injuries; Musculoskeletal Abnormalities; Congenital Abnormalities; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Foot Deformities, Acquired; Ankle Injuries; Wounds and Injuries; Foot Deformities; Foot Deformities, Congenital; Flatfoot; Foot Injuries
• Other Study ID Numbers: GN22OR165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised data available on request via email to the corresponding author
• IPD Sharing Time Frame: Data is available after publication
• IPD Sharing Access Criteria: For academic and research purposes
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No