Foot InjuryNCT05444192
Comparing Clinical Outcomes Using Two Insole Manufacture Techniques
A study testing CAD/CAM insoles in people with Foot Injury and Foot Deformity, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Injury, Foot Deformity, Foot Sprain
- What is being tested?
- CAD/CAM insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Sep 2022to 24 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Orthotics Department, Glasgow Royal Infirmary
Glasgow, G4 0SF
About this study
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
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.
Read the 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
- Being tested
- CAD/CAM insoles
- Medical subject headings
- Foot Injuries, Foot Deformities, Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/CAM insolesDevice
computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: CAD/CAM insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
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: 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: 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: 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.
Measured: Costs were calculated per participant from baseline until their completion of the trial at week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start29 Sep 2022
- Primary completion24 Nov 2023
- Study completion24 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Foot InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Central Lancashire
- Responsible party
- Sponsor
- Investigators
- Graham Chapman, Principal investigator, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444192
- Sponsor's protocol ID
- GN22OR165
- Status last verified
- May 2025
- First submitted
- 16 Jun 2022
- Last updated
- 23 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data available on request via email to the corresponding author
Publications
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.
PubMed 40121418Barr 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.
PubMed 38569685
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05444192
- Acronym / sponsor ID
- GN22OR165
- Conditions
- Foot Injury, Foot Deformity, Foot Sprain, Feet, Flat, Foot Ankle Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Central Lancashire
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 5 Jul 2022 (actual)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insoles manufactured from foam-box cast | Active comparator | Device: CAD/CAM insolesBoth arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study. |
| insoles manufactured from direct 3D scan | Active comparator | Device: CAD/CAM insolesBoth arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAD/CAM insolescomputer-aided-design computer-aided-manufacture (CAD/CAM) insoles | Device | insoles manufactured from direct 3D scan, insoles manufactured from foam-box cast |
Primary outcome
Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain
Time frame: 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
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.
4 secondary outcomes
Foot Health Status Questionnaire (FHSQ) - Function Sub-domain
Time frame: 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
Time frame: 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)
Time frame: Measured 12 weeks after being fitted with insoles
Differential Cost Analysis
Time frame: Costs were calculated per participant from baseline until their completion of the trial at week 12.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40121418Barr 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.
- Derived from this study: PubMed 38569685Barr 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.
- Individual participant dataSharing planned: Yes. Anonymised data available on request via email to the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham Chapman principal investigator
University of Central Lancashire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAD/CAM insoles in people with Foot Injury and Foot Deformity, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05444192, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.