Comparing Clinical Outcomes Using Two Insole Manufacture Techniques

Foot Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05444192
• Other study ID #: GN22OR165
• Status: Completed
• Phase: N/A
• Start date: September 29, 2022
• Est. completion date: November 24, 2023

Study information

• Verified date: January 2024
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: November 24, 2023
• Est. primary completion date: November 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ankle Injuries
• Flatfoot
• Foot Ankle Injuries
• Foot Deformities
• Foot Deformity
• Foot Injuries
• Foot Injury
• Wounds and Injuries

Intervention

Device:
• CAD/CAM insoles
computer-aided-design computer-aided-manufacture (CAD/CAM) insoles

Locations

Country	Name	City	State
United Kingdom	Orthotics Department, Glasgow Royal Infirmary	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Central Lancashire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tertiary outcome measure - Recruitment rate	Recruitment rate = n/recruitment period	Measured from the date of 1st participant being recruited, until recruitment completed. Anticipated 9 months.
Other	Tertiary outcome measure - Participant compliance with the study protocol / Adherence	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 the date of 1st participant being recruited, until trial completed. Anticipated 12 months.
Other	Tertiary outcome measure - Dropout rate	Dropout rate = n dropout/duration of trial	Measured from the date of 1st participant being recruited, until trial completed. Anticipated 12 months.
Primary	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	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	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	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	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	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	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	Measured 12 weeks after being fitted with insoles
Secondary	time-in-transit	Measurement of transit times associated with each arm of the trial will be compared. This will be measured in days. Measuring the number of days for each insole to be delivered after foot shape capture.	Measured for each participant, from the day of foot-shape-capture to the time of insoles being delivered to the Glasgow Royal Infirmary, up to 42 days.