Evaluation of Additive Manufacture in the Production of Orthotic Insoles
AMinO
Efficacy of Additive Manufactured Orthotic Insoles for the Reduction of Forefoot Plantar Pressure in the Diabetic Foot.
1 other identifier
interventional
25
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes
Started Jul 2016
Shorter than P25 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 26, 2016
CompletedFirst Posted
Study publicly available on registry
September 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFebruary 28, 2017
February 1, 2017
6 months
August 26, 2016
February 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of forefoot pressure to below safety threshold
Number of participants with all forefoot plantar pressure \< 200kPa when wearing the orthotic compared to without the orthotic. This will be measured over 6 months of trial to assess if product performance is maintained over duration of use.
6 months
Secondary Outcomes (13)
Change in forefoot pressure
6 months
Patient Outcomes - Quality of Life
6 months
Patient Outcomes - Capability
6 months
Patient Outcomes - Foot Health
6 months
Patient Outcomes - Orthotic Fit
6 months
- +8 more secondary outcomes
Study Arms (3)
Additive Manufactured Orthotic Device
EXPERIMENTALDevice will be produced via additive manufacture to the specification of a Health and Care Professions Council (HCPC) registered orthotist based on a digital foot scan.
Moulded Orthotic Device
OTHERHistoric control collected using same protocol. Intervention was a moulded orthotic device produced from an impression box of the foot shape.
Milled Orthotic Device
OTHERHistoric control collected using same protocol. Device will be produced via Computer Aided Design/Computer Aided Manufacture (CAD/CAM) milling to the specification of a HCPC registered orthotist based on a digital foot scan.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Are aged between 40 and 85
- Have diabetes
- Have all normal foot structures
- Have sensory neuropathy
- Have detectable pulses in feet
- Have non-standard footwear provided by the orthotics department
- Able to walk 50 meters unaided without stopping
You may not qualify if:
- Pregnant or Nursing
- Had prior major injuries to the lower limb (eg. Fractures, skin graft)
- Have active persistent foot or leg ulceration within last 2 years.
- The participant may also not be suitable to participate if they have any of the following conditions:
- Ischemia or poor blood supply to your feet
- Charcot Arthropathy
- Connective tissue diseases (for example scleroderma, systemic lupus erythematosus).
- Autoimmune diseases (e.g. rheumatoid arthritis).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Salfordlead
- FDM Digital Solutions Ltdcollaborator
- East Lancashire Hospitals NHS Trustcollaborator
- Salford Insolecollaborator
- Bangor Universitycollaborator
- iBusiness Flocollaborator
Study Sites (1)
Royal Blackburn Hospital
Blackburn, Lancashire, BB2 3HH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
August 26, 2016
First Posted
September 9, 2016
Study Start
July 1, 2016
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
February 28, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share