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Comparing Clinical Outcomes Using Two Insole Manufacture Techniques

NCT05444192 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2025-05-23

Study results available
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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.

Conditions

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

Interventions

DEVICE

CAD/CAM insoles

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

Sponsors & Collaborators

  • University of Central Lancashire

    collaborator OTHER

  • NHS Greater Glasgow and Clyde

    lead OTHER

Principal Investigators

  • Graham Chapman · University of Central Lancashire

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-29
Primary Completion
2023-11-24
Completion
2023-11-24

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05444192 on ClinicalTrials.gov