N/A
N=114
Comparing Clinical Outcomes Using Two Insole Manufacture Techniques
Foot Injury · Foot Deformity · Foot Sprain · Feet, Flat · Foot Ankle Injuries
Bottom Line
View on ClinicalTrials.gov: NCT05444192 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain — 78.13; 78.75; 72.50; 78.13 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CAD/CAM insoles (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NHS Greater Glasgow and Clyde
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain |
78.13; 78.75; 72.50; 78.13; 72.50; 78.13 | — |
| SECONDARY Foot Health Status Questionnaire (FHSQ) - Function Sub-domain |
87.50; 93.75; 75.00; 93.75; 87.50; 87.50 | — |
| SECONDARY Foot Health Status Questionnaire - Foot Health Sub-domain |
60.00; 72.50; 46.25; 72.50; 42.50; 60.00 | — |
| SECONDARY Orthotic and Prosthetic User Survey9-12 (Satisfaction With Device Survey) |
69.48; 76.35 | — |
| SECONDARY Differential Cost Analysis |
55.46; 44.94 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05444192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.