Evaluation of Additive Manufacture in the Production of Orthotic Insoles

Summary

This study will assess the ability of different orthotic insole treatments to reduce pressure under the ball of the foot. This is important for people who have diabetes because their feet are at higher risk of foot problems in this area. This study will involve the participants wearing a a range of insoles produced by milling, handmade processes and additive manufacture along with normal orthotic footwear. A researcher will measure the pressures under the feet while the participants walk wearing the orthotic insoles.

Conditions

• Diabetes

Interventions

DEVICE

Additive Manufactured Orthotic Device

The 3D foot scan data will be used to generate a 3D model of the foot orthotic which will then be adapted to be suitable for solid printing. The final model will be saved in .stl format for use in the printing software. The additive manufactured orthotic insoles and all features or additions will be produced in a single build from additive materials matched for hardness to medium density EVA. Post production the orthotic will be cleaned to remove support material and a top cover will be attached to the final additive manufactured orthotic insole.

DEVICE

Moulded orthotic

The foam impression box and prescription will be sent to an external company for production of the handmade moulded orthotics. Handmade moulded orthotics will be produced by heating and wrapping medium density Ethylene-vinyl acetate (EVA) around plaster casts of the impression boxes. The orthotic insoles may be manually adapted to meet the requirements of the prescription, this could include cut out sections designed to offload regions of the foot or the addition of features such as metatarsal bars which provide varied support. Features and additions will be added in post manually by cutting and gluing onto the moulded orthotic insole. A top cover will be attached to the final moulded orthotic insole.

DEVICE

Milled orthotic

The 3D foot scan data will be used to generate a 3D model of the foot orthotic. This will then be saved in .pan format for use in a CNC milling software. Orthotics and all features will be milled in a single mill from a block of medium density EVA. Post milling the orthotics will be cleaned. The orthotic insoles may be manually adapted to meet the requirements of the prescription, this could include cut out sections designed to offload regions of the foot or the addition of features such as metatarsal bars which provide varied support. Features and additions will be added in post manually by cutting and gluing onto the milled orthotic insole. A top cover will be attached to the final milled orthotic insole.

Sponsors & Collaborators

• FDM Digital Solutions Ltd

  collaborator UNKNOWN

• East Lancashire Hospitals NHS Trust

  collaborator OTHER

• Salford Insole

  collaborator UNKNOWN

• Bangor University

  collaborator OTHER

• iBusiness Flo

  collaborator UNKNOWN

• University of Salford

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

40 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-07-31

Primary Completion

2017-01-31

Completion

2017-01-31

Countries

• United Kingdom

Study Locations