Diabetes Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
The LOMIS study is divided into three parts to allow safe and controlled development of a novel device to measure forces under the foot during footwear use in routine daily activities.
Participants a
Sponsors
University of Salford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 20/02/2024: 1. Have diabetes diagnosed by a medical practitioner 2. Are capable of providing informed consent to participate 3. Are aged between 18-85 years 4. Feet classified as a "low, moderate or high risk" by IWGDF Risk Stratification System 5. Have the self-reported capability to walk unaided and without stopping for 25 m Previous inclusion criteria: 1. Have diabetes diagnosed by a medical practitioner 2. Are capable of providing informed consent to participate 3. Are aged between 18-85 years 4. Have the self-reported capability to walk unaided and without stopping for 100 m 5. Have the self-reported capability to be physically active (either aided or unaided with breaks) for 2.5 hours per day 6. Can use a smartphone and its applications. 7. Have received two COVID-19 vaccinations
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 20/02/2024: 1. Are pregnant 2. Have active foot or leg ulceration 3. Have foot infection 4. Have active Charcot joint 5. Have prior major injuries to lower limb (e.g. fractures requiring internal fixation, skin grafts) 6. Have clinically relevant foot deformity which prevents orthotic provision (eg. Rigid plantarflexed heel) 7. Have major amputation of the lower limbs and foot, this does not include minor amputation of lesser toes 8. Have severe lower extremity artery disease (Peripheral Arterial Disease or Critical Limb Ischaemia) 9. Have any pathologic conditions limiting the participant’s ability to walk unaided and without stopping for 25m (eg, cerebrovascular diseases, cardiopulmonary, or other systemic diseases). 10. Have major vascular complications (e.g. Critical Limb Ischaemia) 11. Have severe retinopathy 12. Use walking aids that offload the foot (e.g. Aircast Boot) 13. Use lower limb orthosis during the intervention period which limit ankle movement (e.g. Ankle Foot Orthoses) 14. Have visual impairment that limits normal use of smartphones 15. Have dementia 16. Have uncorrected psychological impairment; psychiatric illnesses or social situations limiting compliance with the study 17. Have inner ear pathology or other serious underlying balance dysfunction 18. Have current participation in another clinical investigation of a medical device or a drug 19. Have a Body-mass index (BMI) of more than 50 kg/m² Previous exclusion criteria: 1. Have any of the symptoms related to COVID-19 2. Are pregnant 3. Have active foot or leg ulceration 4. Have foot infection 5. Have active Charcot joint 6. Have prior major injuries to lower limb (e.g., fractures requiring internal fixation, skin grafts) 7. Have clinically relevant foot deformity which prevents orthotic provision (e.g. rigid plantarflexed heel) 8. Have amputation of the lower limbs 9. Have severe lower extremity artery disease (Intermittent claudication or rest pain) 10. Have any pathologic conditions limiting the participant’s ability to walk unaided and without stopping for 100 m (e.g., cerebrovascular diseases, cardiopulmonary, or other systemic diseases) 11. Have major vascular complications 12. Have severe retinopathy 13. Use walking aids that offload the foot 14. Use lower limb orthosis during the intervention period 15. Have visual impairment that limits normal use of smartphones 16. Have dementia 17. Have uncorrected psychological impairment; psychiatric illnesses or social situations limiting compliance with the study 18. Have inner ear pathology or other serious underlying balance dysfunction 19. Have current participation in another clinical investigation of a medical device or a drug 20. Have a body mass index (BMI) of more than 40 kg/m²
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device functionality for application in a daily living environment for the intended purpose of capturing pressure and shear in a range of activities akin to normal and expected use will be assessed through gait lab assessment, and controlled dynamic activity at baseline. This will be further assessed through physical activity logs and device fault at 1, 2, 3, 6, 9 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Device functionality for real-time feedback is measured through a digital fault log captured by the LOMIS system and a fault log captured in assessment appointments at 1, 2, 3, 6, 9 and 12 months 2. Functionality for footwear fit is assessed through a footwear record, physical activity log, and device fault log at 1, 2, 3, 6, 9 and 12 months. Additionally, this will be assessed within an optional qualitative feedback interview 3. Safety of the LOMIS device is assessed through adverse event logs, device fault logs, clinical assessment at 1, 2, 3, 6, 9 and 12 months. Additional telephone reviews will occur at weeks 1, 2, 3, 5, 6, 7, 9, 10 and 11 and then monthly at months 4, 5, 7, 8, 10 and 11 4. Data validity will be assessed against force plate data within a gait lab assessment at baseline and by comparison of physical activity log and device data at 1, 2, 3, 6, 9 and 12 months 5. Feasibility of LOMIS device for application in daily living will be assessed by study recruitment/retention, device fault logs, physical activity logs, device usability questionnaire (QUEST) and mobility questionnaire at 1, 2, 3, 6, 9 and 12 months. Additionally, this will be assessed within an optional qualitative feedback interview 6. Usability of the LOMIS Device for application in daily living will be assessed by the device usability questionnaire (QUEST), mobility questionnaire, and device fault log at 1, 2, 3, 6, 9 and 12 months. Additionally, this will be assessed within an optional qualitative feedback interview | — |
Countries
England, United Kingdom
Outcome results
None listed