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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05444192
Other study ID # GN22OR165
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 29, 2022
Est. completion date November 24, 2023

Study information

Verified date January 2024
Source NHS Greater Glasgow and Clyde
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


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Study Design


Intervention

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

Locations

Country Name City State
United Kingdom Orthotics Department, Glasgow Royal Infirmary Glasgow

Sponsors (2)

Lead Sponsor Collaborator
NHS Greater Glasgow and Clyde University of Central Lancashire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Tertiary outcome measure - Recruitment rate Recruitment rate = n/recruitment period Measured from the date of 1st participant being recruited, until recruitment completed. Anticipated 9 months.
Other Tertiary outcome measure - Participant compliance with the study protocol / Adherence Patients will keep a diary of daily wear time in hours, in accordance with prior publications on measuring Orthotic Adherence. The minimum threshold for adherence is >21 hours per week Measured from the date of 1st participant being recruited, until trial completed. Anticipated 12 months.
Other Tertiary outcome measure - Dropout rate Dropout rate = n dropout/duration of trial Measured from the date of 1st participant being recruited, until trial completed. Anticipated 12 months.
Primary Foot Health Status Questionnaire (FHSQ) - Pain sub-domain To compare the changes in pain in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods 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
Secondary Foot Health Status Questionnaire (FHSQ) - Function sub-domain To compare the changes in foot function in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods 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
Secondary Foot Health Status Questionnaire - foot health sub-domain To compare the changes in foot health in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods 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
Secondary Orthotic and Prosthetic User Survey9-12 (Satisfaction with device survey) To compare the patient satisfaction in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods Measured 12 weeks after being fitted with insoles
Secondary time-in-transit Measurement of transit times associated with each arm of the trial will be compared. This will be measured in days. Measuring the number of days for each insole to be delivered after foot shape capture. Measured for each participant, from the day of foot-shape-capture to the time of insoles being delivered to the Glasgow Royal Infirmary, up to 42 days.
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