Diabetes Clinical Trial
— AMinOOfficial title:
Efficacy of Additive Manufactured Orthotic Insoles for the Reduction of Forefoot Plantar Pressure in the Diabetic Foot.
Verified date | February 2017 |
Source | University of Salford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Blackburn Hospital | Blackburn | Lancashire |
Lead Sponsor | Collaborator |
---|---|
University of Salford | Bangor University, East Lancashire Hospitals NHS Trust, FDM Digital Solutions Ltd, iBusiness Flo, Salford Insole |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 6 months | |
Secondary | Patient Outcomes - Quality of Life | Quality of life measure - EuroQol five dimensions questionnaire (EQ-5D) | 6 months | |
Secondary | Patient Outcomes - Capability | Capability and well being measure - ICEpop CAPability measure for Adults (ICECAP-A) | 6 months | |
Secondary | Patient Outcomes - Foot Health | Foot/Pathology status - Foot health status questionnaire. | 6 months | |
Secondary | Patient Outcomes - Orthotic Fit | Percentage of participants own footwear that the orthotics fit into (self-reported %) Compliance (Telephone monitoring) | 6 months | |
Secondary | Organisation outcome - Enquiries | Number of enquiries (e.g. telephone) from patients post dispensing of the orthotics (over 6 months of trial) | 6 months | |
Secondary | 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. | 6 months | |
Secondary | Organisation outcome - Products | Number of footwear products provided by orthotics service. This will be measured over 6 months of trial. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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 | 6 months | |
Secondary | 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 | 6 months | |
Secondary | 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 | 6 months | |
Secondary | Clinician confidence in orthotics service | measured through structured focus group/interviews and narrative analysis: Improved evidence base to inform service improvements | 6 months |
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