Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
NCT ID:
NCT05444192
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05444192
Study Brief:
Protocol Section:
NCT05444192