Evaluation of Additive Manufacture in the Production of Orthotic Insoles
- Conditions
- Diabetes
- Interventions
- Device: Additive Manufactured Orthotic DeviceDevice: Moulded orthoticDevice: Milled orthotic
- Registration Number
- NCT02895139
- Lead Sponsor
- University of Salford
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Additive Manufactured Orthotic Device 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. Moulded Orthotic Device Moulded orthotic Historic control collected using same protocol. Intervention was a moulded orthotic device produced from an impression box of the foot shape. Milled Orthotic Device Milled orthotic 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.
- Primary Outcome Measures
Name Time Method Reduction of forefoot pressure to below safety threshold 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.
- Secondary Outcome Measures
Name Time Method Patient Outcomes - Capability 6 months Capability and well being measure - ICEpop CAPability measure for Adults (ICECAP-A)
Patient experience and satisfaction with orthotics 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
Patient engagement with health service 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
Organisation outcome - Products 6 months Number of footwear products provided by orthotics service. This will be measured over 6 months of trial.
Clinician confidence in orthotics service 6 months measured through structured focus group/interviews and narrative analysis: Improved evidence base to inform service improvements
Change in forefoot pressure 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.
Patient Outcomes - Quality of Life 6 months Quality of life measure - EuroQol five dimensions questionnaire (EQ-5D)
Patient Outcomes - Orthotic Fit 6 months Percentage of participants own footwear that the orthotics fit into (self-reported %) Compliance (Telephone monitoring)
Organisation outcome - Appointments 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.
Patient Confidence 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
Patient Outcomes - Foot Health 6 months Foot/Pathology status - Foot health status questionnaire.
Organisation outcome - Enquiries 6 months Number of enquiries (e.g. telephone) from patients post dispensing of the orthotics (over 6 months of trial)
Organisation outcome - Impact on wider healthcare use 6 months Clinical Service Receipt Inventory - primary and secondary health and social care use. This will be measured over 6 months of trial.
Trial Locations
- Locations (1)
Royal Blackburn Hospital
🇬🇧Blackburn, Lancashire, United Kingdom