An interventional study of CAD/CAM insoles in Foot Injury, Foot Deformity and Foot Sprain, sponsored by NHS Greater Glasgow and Clyde. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-23.
Sponsored by NHS Greater Glasgow and Clyde · Not applicable, Interventional, and Treatment
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.
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.
60 studies on the registry are indexed under Foot Injuries; 15 are open to participants now.
This study's enrollment of 114 is above the median of 60 across 46 interventional studies indexed under Foot Injuries.
Browse Foot Injuries studies →NHS Greater Glasgow and Clyde is the lead sponsor of 220 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
Device: CAD/CAM insoles
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
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.
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 (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.
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
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.
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)
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.
Time frame: 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.
Time frame: Costs were calculated per participant from baseline until their completion of the trial at week 12.
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
Time frame: Measured from baseline until completion of the trial at week 12
Tertiary Outcome Measure - Dropout Rate
Dropout rate = n dropout at end of trial
Time frame: Measured from baseline to completion of the trial at 12 weeks, for each participant
| Milestone | Insoles Manufactured From Foam-box Cast | Insoles Manufactured From Direct 3D Scan |
|---|---|---|
| Started | 57 | 57 |
| Completed | 56 | 57 |
| Not completed | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
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.
| units on a scale | Insoles Manufactured From Foam-box Cast | Insoles Manufactured From Direct 3D Scan |
|---|---|---|
| 12 weeks following intervention | 78.13 (53.75 to 92.97) | 78.75 (53.75 to 93.75) |
| 8 weeks following intervention | 72.50 (49.53 to 84.38) | 78.13 (54.06 to 85.00) |
| 4 weeks following intervention | 72.50 (57.19 to 84.38) | 78.13 (48.13 to 84.38) |
| Baseline | 48.13 (29.38 to 71.88) | 53.75 (27.19 to 72.50) |
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.
| units on a scale | Insoles Manufactured From Foam-box Cast | Insoles Manufactured From Direct 3D Scan |
|---|---|---|
| 12 weeks following intervention | 87.50 (68.75 to 100.00) | 93.75 (65.63 to 100.0) |
| 8 weeks following intervention | 75.00 (51.56 to 93.75) | 93.75 (59.38 to 100.00) |
| 4 weeks following intervention | 87.50 (57.81 to 93.75) | 87.50 (62.50 to 100.00) |
| Baseline | 68.75 (43.75 to 87.50) | 62.50 (37.50 to 90.63) |
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.
| units on a scale | Insoles Manufactured From Foam-box Cast | Insoles Manufactured From Direct 3D Scan |
|---|---|---|
| 12 weeks following intervention | 60.00 (25.00 to 81.88) | 72.50 (25.00 to 85.00) |
| 8 weeks following intervention | 46.25 (25.00 to 69.38) | 72.50 (25.00 to 85.00) |
| 4 weeks following intervention | 42.50 (25.00 to 72.50) | 60.00 (25.00 to 85.00) |
| Baseline | 25.00 (0.00 to 60.00) | 42.50 (0.00 to 72.50) |
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.
| units on a scale | Insoles Manufactured From Foam-box Cast | Insoles Manufactured From Direct 3D Scan |
|---|---|---|
| Orthotic and Prosthetic User Survey9-12 (Satisfaction With Device Survey) | 69.48 (64.59 to 74.36) | 76.35 (71.84 to 80.86) |
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.
| cost in pounds and pence per participant | Insoles Manufactured From Foam-box Cast | Insoles Manufactured From Direct 3D Scan |
|---|---|---|
| Differential Cost Analysis | 55.46 (51.28 to 60.36) | 44.94 (39.98 to 48.12) |
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
| Hours | Insoles Manufactured From Foam-box Cast | Insoles Manufactured From Direct 3D Scan |
|---|---|---|
| Tertiary Outcome Measure - Hours of Insole Wear Time Per Day | 5.08 (4.66 to 5.50) | 6.09 (5.68 to 6.51) |
Dropout rate = n dropout at end of trial
| Participants | Insoles Manufactured From Foam-box Cast | Insoles Manufactured From Direct 3D Scan |
|---|---|---|
| Tertiary Outcome Measure - Dropout Rate | 2 | 0 |
Collected over 14 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Insoles Manufactured From Foam-box Cast | 0/57 (0%) | 0/57 (0%) | 7/57 (12.3%) |
| Insoles Manufactured From Direct 3D Scan | 0/57 (0%) | 0/57 (0%) | 2/57 (3.5%) |
| Event | Insoles Manufactured From Foam-box Cast | Insoles Manufactured From Direct 3D Scan |
|---|---|---|
| Advenrse eventSkin and subcutaneous tissue disorders | 7/57 | 2/57 |
| Age, Continuous(years) | Insoles Manufactured From Foam-box Cast | Insoles Manufactured From Direct 3D Scan | Total |
|---|---|---|---|
| Median | 50.0 (32.0 to 61.0) | 50.0 (34.0 to 59.0) | 50.0 (33.0 to 60.0) |
| Sex: Female, Male(Participants) | Insoles Manufactured From Foam-box Cast | Insoles Manufactured From Direct 3D Scan | Total |
|---|---|---|---|
| Female | 41 | 41 | 82 |
| Male | 16 | 16 | 32 |
| Race/Ethnicity, Customized(Participants) | Insoles Manufactured From Foam-box Cast | Insoles Manufactured From Direct 3D Scan | Total |
|---|---|---|---|
| Ethnicity — White | 56 | 56 | 112 |
| Ethnicity — Other (mixed) | 0 | 1 | 1 |
| Ethnicity — African | 1 | 0 | 1 |
| Area of primary musculoskeletal pathology(Participants) | Insoles Manufactured From Foam-box Cast | Insoles Manufactured From Direct 3D Scan | Total |
|---|---|---|---|
| Ankle | 21 | 24 | 45 |
| First ray | 3 | 10 | 13 |
| Forefoot | 17 | 10 | 27 |
| Lower leg | 0 | 1 | 1 |
| Midfoot | 4 | 1 | 5 |
| Plantar heel / plantar fascia | 12 | 11 | 23 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Anonymised data available on request via email to the corresponding author
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data is available after publication
Access criteria: For academic and research purposes
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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