CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 114 enrolled
Drug / intervention
CAD/CAM insolesdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05444192
NCT05444192N/ACompleted

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

NHS Greater Glasgow and Clyde·interventional·Posted Jul 5, 2022·Updated May 23, 2025

In Brief

A clinical study evaluating CAD/CAM insoles for Foot Injury and 4 related conditions. Completed, enrolled 114 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
2023202420252026
First PostedJul 5, 2022
Enrollment StartSep 29, 2022
Primary CompletionNov 24, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.0 years ago

Interventions

CAD/CAM insolesdevice

computer-aided-design computer-aided-manufacture (CAD/CAM) insoles