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Comparing Clinical Outcomes Using Two Insole Manufacture Techniques

Primary Purpose

Foot Injury, Foot Deformity, Foot Sprain

Status

Recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

CAD/CAM insoles

About this trial

This is an interventional treatment trial for Foot Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Orthotics Department, Glasgow Royal InfirmaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

insoles manufactured from foam-box cast

insoles manufactured from direct 3D scan

Arm Description

Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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.

Full Information

NCT ID

NCT05444192

First Posted

June 16, 2022

Last Updated

March 2, 2023

Sponsor

NHS Greater Glasgow and Clyde

Collaborators

University of Central Lancashire

1. Study Identification

Unique Protocol Identification Number

NCT05444192

Brief Title

Comparing Clinical Outcomes Using Two Insole Manufacture Techniques

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 29, 2022 (Actual)

Primary Completion Date

November 24, 2023 (Anticipated)

Study Completion Date

November 24, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NHS Greater Glasgow and Clyde

Collaborators

University of Central Lancashire

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

insoles manufactured from foam-box cast

Arm Type

Active Comparator

Arm Description

Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.

Arm Title

insoles manufactured from direct 3D scan

Arm Type

Active Comparator

Arm Description

Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.

Intervention Type

Device

Intervention Name(s)

CAD/CAM insoles

Intervention Description

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

Primary Outcome Measure Information:

Title

Foot Health Status Questionnaire (FHSQ) - Pain sub-domain

Description

To compare the changes in pain in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods

Time Frame

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 Outcome Measure Information:

Title

Foot Health Status Questionnaire (FHSQ) - Function sub-domain

Description

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

Time Frame

Title

Foot Health Status Questionnaire - foot health sub-domain

Description

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

Time Frame

Title

Orthotic and Prosthetic User Survey9-12 (Satisfaction with device survey)

Description

To compare the patient satisfaction in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods

Time Frame

Measured 12 weeks after being fitted with insoles

Title

time-in-transit

Description

Time Frame

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.

Other Pre-specified Outcome Measures:

Title

Tertiary outcome measure - Recruitment rate

Description

Recruitment rate = n/recruitment period

Time Frame

Measured from the date of 1st participant being recruited, until recruitment completed. Anticipated 9 months.

Title

Tertiary outcome measure - Participant compliance with the study protocol / Adherence

Description

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

Time Frame

Measured from the date of 1st participant being recruited, until trial completed. Anticipated 12 months.

Title

Tertiary outcome measure - Dropout rate

Description

Dropout rate = n dropout/duration of trial

Time Frame

Measured from the date of 1st participant being recruited, until trial completed. Anticipated 12 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Laura Barr

Phone

0141 211 1459

laura.barr@ggc.scot.nhs.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Graham Chapman

Phone

01772 894949

gchapman2@uclan.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Graham Chapman

Organizational Affiliation

University of Central Lancashire

Official's Role

Principal Investigator

Facility Information:

Facility Name

Orthotics Department, Glasgow Royal Infirmary

City

Glasgow

ZIP/Postal Code

G4 0SF

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pamela Sandu

Phone

01413144414

pamela.sandu@ggc.scot.nhs.uk

First Name & Middle Initial & Last Name & Degree

Laura Barr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparing Clinical Outcomes Using Two Insole Manufacture Techniques

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