Comparing Clinical Outcomes Using Two Insole Manufacture Techniques

NCT ID: NCT05444192

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-29
• Study Completion Date: 2023-11-24

Brief 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.

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.

Conditions

Foot Injury; Foot Deformity; Foot Sprain; Feet, Flat; Foot Ankle Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

CAD/CAM insoles

Intervention Type: DEVICE

computer-aided-design computer-aided-manufacture (CAD/CAM) insoles

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.

Group Type: ACTIVE_COMPARATOR

CAD/CAM insoles

Intervention Type: DEVICE

computer-aided-design computer-aided-manufacture (CAD/CAM) insoles

Interventions

CAD/CAM insoles

computer-aided-design computer-aided-manufacture (CAD/CAM) insoles

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Central Lancashire

OTHER

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Graham Chapman

Role: PRINCIPAL_INVESTIGATOR

University of Central Lancashire

Locations

Orthotics Department, Glasgow Royal Infirmary

Glasgow, , United Kingdom

Countries

United Kingdom

References

Barr L, Richards J, Dickson C, Tawse J, Munro N, Scott H, Holland A, Chapman GJ. To scan or not to scan? Comparing the effectiveness and cost differential of insoles manufactured from foam-box casts versus direct scans in treating musculoskeletal conditions of the foot and ankle: a double-blinded, randomised controlled trial. BMC Musculoskelet Disord. 2025 Mar 22;26(1):282. doi: 10.1186/s12891-025-08513-2.

Reference Type: DERIVED

PMID: 40121418 (View on PubMed)

Barr L, Richards J, Chapman GJ. Comparing the effectiveness of computer-aided design/computer-aided manufacturing (CAD/CAM) of insoles manufactured from foam box cast versus direct scans on patient-reported outcome measures: a protocol for a double-blinded, randomised controlled trial. BMJ Open. 2024 Apr 2;14(4):e078240. doi: 10.1136/bmjopen-2023-078240.

Reference Type: DERIVED

PMID: 38569685 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

GN22OR165

Identifier Type: -

Identifier Source: org_study_id