- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02895139
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is divided into multiple appointments over which the investigators assess the performance of the orthotic insoles the participants are using.
Screening Appointment (1 hour): The participants will be asked to come to the orthotics department at the Royal Blackburn Hospital. A clinician will perform a routine clinical foot assessment, which will include taking photographs of the feet, to ensure it is safe for the participants to participate in the study. If the participants are not eligible they will not be able to participate in the study, this will not affect the participants normal orthotic care. If the participants are eligible, information on the shape of their feet will be taken using a 3D foot scanner to allow the investigators to produce suitable insoles.
Supply Appointment (1 hour): When the insole is ready the participants will come in for a supply appointment the investigators will check that the insoles and shoes the participants will receive are the correct shape, design and are suitable to wear. At this appointment the investigators will measure the pressure under the feet whilst walking wearing the insoles to check the insole is working correctly. This is done using a thin layer of flexible sensors which go into the participants shoes. The participants will then receive insoles to take home and wear as normal.
After the participants have been supplied with orthotic insoles, a member of the National Health Service (NHS) clinical team will contact them by telephone. This will be each week for the first 4 weeks and then once a month until six months. The call will last no more than 15 minutes and the participants will be asked about their general health, the NHS foot care services they may have used and about the orthotic insoles. In addition at 3 and 6 months after the participants received their orthotic insoles they will be asked to come back into the clinic for a review appointment which will take approximately 1 hour. At these appointments the investigators will measure the pressure under their feet again, using a thin layer of flexible sensors that go into the participants shoes on top of the orthotic insole.
The investigators will also be asking some participants if they would be willing to take part in focus group discussions which will allow more detailed questions to be asked about the participants experiences wearing the orthotic insoles. The participants can decide whether to be involved in these independent of the primary trial. These will be held at the Royal Blackburn Hospital.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lancashire
-
Blackburn, Lancashire, United Kingdom, BB2 3HH
- Royal Blackburn Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Additive Manufactured Orthotic Device
Device 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.
|
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.
|
Other: Moulded Orthotic Device
Historic control collected using same protocol.
Intervention was a moulded orthotic device produced from an impression box of the foot shape.
|
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.
|
Other: Milled Orthotic Device
Historic 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of forefoot pressure to below safety threshold
Time Frame: 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in forefoot pressure
Time Frame: 6 months
|
The affect of the orthotic on forefoot plantar pressure (kPa) at each forefoot site which is above 200kPa without orthotic in participants own footwear.
This will be measured over 6 months of trial to assess if product performance is maintained over duration of use.
|
6 months
|
Patient Outcomes - Quality of Life
Time Frame: 6 months
|
Quality of life measure - EuroQol five dimensions questionnaire (EQ-5D)
|
6 months
|
Patient Outcomes - Capability
Time Frame: 6 months
|
Capability and well being measure - ICEpop CAPability measure for Adults (ICECAP-A)
|
6 months
|
Patient Outcomes - Foot Health
Time Frame: 6 months
|
Foot/Pathology status - Foot health status questionnaire.
|
6 months
|
Patient Outcomes - Orthotic Fit
Time Frame: 6 months
|
Percentage of participants own footwear that the orthotics fit into (self-reported %) Compliance (Telephone monitoring)
|
6 months
|
Organisation outcome - Enquiries
Time Frame: 6 months
|
Number of enquiries (e.g.
telephone) from patients post dispensing of the orthotics (over 6 months of trial)
|
6 months
|
Organisation outcome - Appointments
Time Frame: 6 months
|
Number of clinical appointments required by patients to address an issue related to the orthotic after fitting.
This will be measured over 6 months of trial.
|
6 months
|
Organisation outcome - Products
Time Frame: 6 months
|
Number of footwear products provided by orthotics service.
This will be measured over 6 months of trial.
|
6 months
|
Organisation outcome - Impact on wider healthcare use
Time Frame: 6 months
|
Clinical Service Receipt Inventory - primary and secondary health and social care use.
This will be measured over 6 months of trial.
|
6 months
|
Patient Confidence
Time Frame: 6 months
|
measured through structured focus group/interviews and narrative analysis: Confidence in products and supply Confidence in prescription and control over design Confidence in colleagues / service provision
|
6 months
|
Patient experience and satisfaction with orthotics
Time Frame: 6 months
|
measured through structured focus group/interviews and narrative analysis: Changes in footwear experiences over 6 months of orthotic use Comfort of orthotics over 6months of orthotic use Satisfaction with orthotics and the service
|
6 months
|
Patient engagement with health service
Time Frame: 6 months
|
measured through structured focus group/interviews and narrative analysis: Need to adjust health behaviour over 6 months of orthotic use Need to seek further assistance for footwear and foot health over 6 months of orthotic use
|
6 months
|
Clinician confidence in orthotics service
Time Frame: 6 months
|
measured through structured focus group/interviews and narrative analysis: Improved evidence base to inform service improvements
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AM-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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