Evaluation of Additive Manufacture in the Production of Orthotic Insoles

NACompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

July 31, 2016

Primary Completion Date

January 31, 2017

Study Completion Date

January 31, 2017

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.

Trial Locations (1)

BB2 3HH

Royal Blackburn Hospital, Blackburn

All Listed Sponsors
collaborator

FDM Digital Solutions Ltd

UNKNOWN

collaborator

East Lancashire Hospitals NHS Trust

OTHER

collaborator

Salford Insole

UNKNOWN

collaborator

Bangor University

OTHER

collaborator

iBusiness Flo

UNKNOWN

lead

University of Salford

OTHER

NCT02895139 - Evaluation of Additive Manufacture in the Production of Orthotic Insoles | Biotech Hunter | Biotech Hunter