DiabetesAMinONCT02895139
Evaluation of Additive Manufacture in the Production of Orthotic Insoles
A study testing Additive Manufactured Orthotic Device, Moulded orthotic and Milled orthotic in people with Diabetes, run by University of Salford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Additive Manufactured Orthotic Device, Moulded orthotic and Milled orthotic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Blackburn Hospital
Blackburn, Lancashire, BB2 3HH
About this study
Official title: Efficacy of Additive Manufactured Orthotic Insoles for the Reduction of Forefoot Plantar Pressure in the Diabetic Foot.
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Additive Manufactured Orthotic Device, Moulded orthotic, Milled orthotic
- Keywords
- Additive Manufacture, Orthotic Insole
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additive Manufactured Orthotic DeviceDevice
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.
Moulded orthoticDevice
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.
Milled orthoticDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Additive Manufactured Orthotic Device | Experimental | 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. Receives: Device: Additive Manufactured Orthotic Device |
| Moulded Orthotic Device | Other | Historic control collected using same protocol. Intervention was a moulded orthotic device produced from an impression box of the foot shape. Receives: Device: Moulded orthotic |
| Milled Orthotic Device | Other | 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. Receives: Device: Milled orthotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (13)
Change in forefoot pressure
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.
Measured: 6 months
Patient Outcomes - Quality of Life
Quality of life measure - EuroQol five dimensions questionnaire (EQ-5D)
Measured: 6 months
Patient Outcomes - Capability
Capability and well being measure - ICEpop CAPability measure for Adults (ICECAP-A)
Measured: 6 months
Patient Outcomes - Foot Health
Foot/Pathology status - Foot health status questionnaire.
Measured: 6 months
Patient Outcomes - Orthotic Fit
Percentage of participants own footwear that the orthotics fit into (self-reported %) Compliance (Telephone monitoring)
Measured: 6 months
Organisation outcome - Enquiries
Number of enquiries (e.g. telephone) from patients post dispensing of the orthotics (over 6 months of trial)
Measured: 6 months
Organisation outcome - Appointments
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.
Measured: 6 months
Organisation outcome - Products
Number of footwear products provided by orthotics service. This will be measured over 6 months of trial.
Measured: 6 months
Organisation outcome - Impact on wider healthcare use
Clinical Service Receipt Inventory - primary and secondary health and social care use. This will be measured over 6 months of trial.
Measured: 6 months
Patient Confidence
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
Measured: 6 months
Patient experience and satisfaction with orthotics
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
Measured: 6 months
Patient engagement with health service
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
Measured: 6 months
Clinician confidence in orthotics service
measured through structured focus group/interviews and narrative analysis: Improved evidence base to inform service improvements
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Collaborators
- FDM Digital Solutions Ltd, East Lancashire Hospitals NHS Trust, Salford Insole, Bangor University, iBusiness Flo
- Responsible party
- Principal investigator, Daniel Parker, University of Salford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895139
- Sponsor's protocol ID
- AM-1
- Acronym
- AMinO
- Status last verified
- Feb 2017
- First submitted
- 26 Aug 2016
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Additive Manufactured Orthotic Insoles for the Reduction of Forefoot Plantar Pressure in the Diabetic Foot.
- ClinicalTrials.gov ID
- NCT02895139
- Acronym / sponsor ID
- AMinO / AM-1
- Conditions
- Diabetes
- Keywords
- Additive Manufacture, Orthotic Insole
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Collaborators
- FDM Digital Solutions Ltd, East Lancashire Hospitals NHS Trust, Salford Insole, Bangor University, iBusiness Flo
- Study start
- Jul 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Additive Manufactured Orthotic Device | Experimental | Device: Additive Manufactured Orthotic DeviceDevice 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 | Other | Device: Moulded orthoticHistoric control collected using same protocol. Intervention was a moulded orthotic device produced from an impression box of the foot shape. |
| Milled Orthotic Device | Other | Device: Milled orthoticHistoric 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are aged between 40 and 85
- Have diabetes
- Have all normal foot structures
- Have sensory neuropathy
- Have detectable pulses in feet
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additive Manufactured Orthotic DeviceThe 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 | Additive Manufactured Orthotic Device |
| Moulded orthoticThe 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 | Moulded Orthotic Device |
| Milled orthoticThe 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. | Device | Milled Orthotic Device |
Primary outcome
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.
13 secondary outcomes
Change in forefoot pressure
Time frame: 6 months
Patient Outcomes - Quality of Life
Time frame: 6 months
Patient Outcomes - Capability
Time frame: 6 months
Patient Outcomes - Foot Health
Time frame: 6 months
Patient Outcomes - Orthotic Fit
Time frame: 6 months
Organisation outcome - Enquiries
Time frame: 6 months
Organisation outcome - Appointments
Time frame: 6 months
Organisation outcome - Products
Time frame: 6 months
Organisation outcome - Impact on wider healthcare use
Time frame: 6 months
Patient Confidence
Time frame: 6 months
Patient experience and satisfaction with orthotics
Time frame: 6 months
Patient engagement with health service
Time frame: 6 months
Clinician confidence in orthotics service
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additive Manufactured Orthotic Device, Moulded orthotic and Milled orthotic in people with Diabetes, run by University of Salford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of forefoot pressure to below safety threshold (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.