Comparing Clinical Outcomes Using Two Insole Manufacture Techniques (NCT05444192) | Clinical Trial Compass
CompletedNot Applicable
Comparing Clinical Outcomes Using Two Insole Manufacture Techniques
United Kingdom114 participantsStarted 2022-09-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain
Timeframe: 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