NCT05444192

Comparing Clinical Outcomes Using Two Insole Manufacture Techniques

Comparing the Effectiveness of Computer-aided-design Computer-aided-manufacture (CAD/CAM) Insoles Manufactured From Foam-box Cast vs Direct Scan on Patient Reported Outcome Measures: A Double-blinded, Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: NHS Greater Glasgow and Clyde · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Foot Injury
• Foot Deformity
• Foot Sprain
• Feet, Flat
• Foot Ankle Injuries

Interventions

Type	Name	Description
DEVICE	CAD/CAM insoles	computer-aided-design computer-aided-manufacture (CAD/CAM) insoles

Timeline

• Start date: 2022-09-29
• Primary completion: 2023-11-24
• Completion: 2023-11-24
• First posted: 2022-07-05
• Last updated: 2025-05-23
• Results posted: 2025-05-23

Locations

1 site across 1 country: United Kingdom