18 and older, any sex, with Foot Injury or Foot Deformity. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Foot Health Status Questionnaire (FHSQ) - Pain Sub-domainPrimary· 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.
12 weeks following intervention
Group
Value
95% CI
Insoles Manufactured From Foam-box Cast
78.13
53.75 – 92.97
Insoles Manufactured From Direct 3D Scan
78.75
53.75 – 93.75
8 weeks following intervention
Group
Value
95% CI
Insoles Manufactured From Foam-box Cast
72.50
49.53 – 84.38
Insoles Manufactured From Direct 3D Scan
78.13
54.06 – 85.00
4 weeks following intervention
Group
Value
95% CI
Insoles Manufactured From Foam-box Cast
72.50
57.19 – 84.38
Insoles Manufactured From Direct 3D Scan
78.13
48.13 – 84.38
Baseline
Group
Value
95% CI
Insoles Manufactured From Foam-box Cast
48.13
29.38 – 71.88
Insoles Manufactured From Direct 3D Scan
53.75
27.19 – 72.50
Foot Health Status Questionnaire (FHSQ) - Function Sub-domainSecondary· 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 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.
12 weeks following intervention
Group
Value
95% CI
Insoles Manufactured From Foam-box Cast
87.50
68.75 – 100.00
Insoles Manufactured From Direct 3D Scan
93.75
65.63 – 100.0
8 weeks following intervention
Group
Value
95% CI
Insoles Manufactured From Foam-box Cast
75.00
51.56 – 93.75
Insoles Manufactured From Direct 3D Scan
93.75
59.38 – 100.00
4 weeks following intervention
Group
Value
95% CI
Insoles Manufactured From Foam-box Cast
87.50
57.81 – 93.75
Insoles Manufactured From Direct 3D Scan
87.50
62.50 – 100.00
Baseline
Group
Value
95% CI
Insoles Manufactured From Foam-box Cast
68.75
43.75 – 87.50
Insoles Manufactured From Direct 3D Scan
62.50
37.50 – 90.63
Foot Health Status Questionnaire - Foot Health Sub-domainSecondary· 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 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.
12 weeks following intervention
Group
Value
95% CI
Insoles Manufactured From Foam-box Cast
60.00
25.00 – 81.88
Insoles Manufactured From Direct 3D Scan
72.50
25.00 – 85.00
8 weeks following intervention
Group
Value
95% CI
Insoles Manufactured From Foam-box Cast
46.25
25.00 – 69.38
Insoles Manufactured From Direct 3D Scan
72.50
25.00 – 85.00
4 weeks following intervention
Group
Value
95% CI
Insoles Manufactured From Foam-box Cast
42.50
25.00 – 72.50
Insoles Manufactured From Direct 3D Scan
60.00
25.00 – 85.00
Baseline
Group
Value
95% CI
Insoles Manufactured From Foam-box Cast
25.00
0.00 – 60.00
Insoles Manufactured From Direct 3D Scan
42.50
0.00 – 72.50
Orthotic and Prosthetic User Survey9-12 (Satisfaction With Device Survey)Secondary· Measured 12 weeks after being fitted with insoles
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.
Group
Value
95% CI
Insoles Manufactured From Foam-box Cast
69.48
64.59 – 74.36
Insoles Manufactured From Direct 3D Scan
76.35
71.84 – 80.86
Differential Cost AnalysisSecondary· Costs were calculated per participant from baseline until their completion of the trial at week 12.
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.
Group
Value
95% CI
Insoles Manufactured From Foam-box Cast
55.46
51.28 – 60.36
Insoles Manufactured From Direct 3D Scan
44.94
39.98 – 48.12
Tertiary Outcome Measure - Hours of Insole Wear Time Per DaySecondary· Measured from baseline until completion of the trial at week 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
Group
Value
95% CI
Insoles Manufactured From Foam-box Cast
5.08
4.66 – 5.50
Insoles Manufactured From Direct 3D Scan
6.09
5.68 – 6.51
Tertiary Outcome Measure - Dropout RateSecondary· Measured from baseline to completion of the trial at 12 weeks, for each participant
Dropout rate = n dropout at end of trial
Group
Value
95% CI
Insoles Manufactured From Foam-box Cast
2
Insoles Manufactured From Direct 3D Scan
0
Adverse events — posted to ClinicalTrials.gov
Time frame: 14 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NHS Greater Glasgow and Clyde
Last refreshed: 23 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05444192.