Comparing Clinical Outcomes Using Two Insole Manufacture Techniques

NCT05444192 | Completed Results

• 1 other identifier: GN22OR165
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Foot Health Status Questionnaire (FHSQ) - Function Sub-domain

  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

  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)

  Measured 12 weeks after being fitted with insoles

• Differential Cost Analysis

  Costs were calculated per participant from baseline until their completion of the trial at week 12.

Other Outcomes (2)

• Tertiary Outcome Measure - Hours of Insole Wear Time Per Day

  Measured from baseline until completion of the trial at week 12

• Tertiary Outcome Measure - Dropout Rate

  Measured from baseline to completion of the trial at 12 weeks, for each participant

Study Arms (2)

insoles manufactured from foam-box cast

ACTIVE COMPARATOR

Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.

Device: CAD/CAM insoles

insoles manufactured from direct 3D scan

ACTIVE COMPARATOR

Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.

Device: CAD/CAM insoles

Interventions

CAD/CAM insoles DEVICE

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

insoles manufactured from direct 3D scan; insoles manufactured from foam-box cast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Central Lancashire: collaborator

Study Sites (1)

Orthotics Department, Glasgow Royal Infirmary

Glasgow, G4 0SF, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 40121418 DERIVED

• 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.

  PMID: 38569685 DERIVED

MeSH Terms

Conditions

Foot Injuries; Foot Deformities; Flatfoot

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Musculoskeletal Diseases; Talipes; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr Graham Chapman
• Organization: University of Central Lancashire

gchapman2@uclan.ac.uk

01772894949

Study Officials

• Graham Chapman

  University of Central Lancashire

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: July 5, 2022
• Study Start: September 29, 2022
• Primary Completion: November 24, 2023
• Study Completion: November 24, 2023
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data is available after publication
• Access Criteria: For academic and research purposes

Locations

GB (1)