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In-shoe pressure measurement devices are used in research and clinic to quantify plantar foot pressures. Various devices are available, differing in size, sensor number and type; therefore accuracy and repeatability. Three devices (Medilogic, Tekscan and Pedar) were examined in a 2 day x 3 trial design, quantifying insole response to regional and whole insole loading. The whole insole protocol applied an even pressure (50-600 kPa) to the insole surface for 0-30 seconds in the Novel TruBlue TM device. The regional protocol utilised cylinders with contact surfaces of 3.14 and 15.9cm 2 to apply pressures of 50 and 200 kPa. The validity (% difference and Root Mean Square Error: RMSE) and repeatability (Intra-Class Correlation Coefficient: ICC) of the applied pressures (whole insole) and contact area (regional) were outcome variables. Validity of the Pedar system was highest (RMSE 2.6 kPa; difference 3.9%), with the Medilogic (RMSE 27.0 kPa; difference 13.4%) and Tekscan (RMSE 27.0 kPa; difference 5.9%) systems displaying reduced validity. The average and peak pressures demonstrated high between-day repeatability for all three systems and each insole size (ICC≥0.859). The regional protocol contact area % difference ranged from -97 to +249%, but the ICC demonstrated medium to high between-day repeatability (ICC≥0.797). Due to the varying responses of the systems, the choice of an appropriate pressure measurement device must be based on the loading characteristics and the outcome variables sought. Medilogic and Tekscan were most effective between 200-300 kPa; Pedar performed well across all pressures. Contact area was less precise, but relatively repeatable for all systems.3

BackgroundDiabetic foot ulceration is a considerable cost to the NHS and foot orthotic provision is a core strategy for the management of the people with diabetes and a moderate to high risk of foot ulceration. The traditional process to produce a custom-made foot orthotic device is to use manual casting of foot shape and physical moulding of orthoses materials. Parts of this process can be undertaken using digital tools rather than manual processes with potential advantages. The aim of this trial was to provide the first comparison of a traditional orthoses supply chain to a digital supply chain over a 6 month period. The trial used plantar pressure, health status, and health service time and cost data to compare the two supply chains.MethodsFifty-seven participants with diabetes were randomly allocated to each supply chain. Plantar pressure data and health status (EQ5D, ICECAP) was assessed at point of supply and at six-months. The costs for orthoses and clinical services accessed by participants were assessed over the 6 months of the trial. Primary outcomes were: reduction in peak plantar pressure at the site of highest pressure, assessed for non-inferiority to current care. Secondary outcomes were: reduction in plantar pressure at foot regions identified as at risk (> 200 kPa), cost-consequence analysis (supply chain, clinician time, service use) and health status.ResultsAt point of supply pressure reduction for the digital supply chain was non-inferior to a predefined margin and superior (p < 0.1) to the traditional supply chain, but both supply chains were inferior to the margin after 6 months. Custom-made orthoses significantly reduced pressure for at risk regions compared to a flat control (traditional − 13.85%, digital − 20.52%). The digital supply chain was more expensive (+£13.17) and required more clinician time (+ 35 min). There were no significant differences in health status or service use between supply chains.ConclusionsCustom made foot orthoses reduce pressure as expected. Given some assumptions about the cost models we used, the supply chain process adopted to produce the orthoses seems to have marginal impact on overall costs and health status.Trial registrationRetrospectively registered on ISRCTN registry (ISRCTN10978940, 04/11/2015).Electronic supplementary materialThe online version of this article (10.1186/s13047-018-0311-0) contains supplementary material, which is available to authorized users.

The plantar soft tissue is a highly functional viscoelastic structure involved in transferring load to the human body during walking. A Soft Tissue Response Imaging Device was developed to apply a vertical compression to the plantar soft tissue whilst measuring the mechanical response via a combined load cell and ultrasound imaging arrangement. Accuracy of motion compared to input profiles; validation of the response measured for standard materials in compression; variability of force and displacement measures for consecutive compressive cycles; and implementation in vivo with five healthy participants. Static displacement displayed average error of 0.04 mm (range of 15 mm), and static load displayed average error of 0.15 N (range of 250 N). Validation tests showed acceptable agreement compared to a Houndsfield tensometer for both displacement (CMC > 0.99 RMSE > 0.18 mm) and load (CMC > 0.95 RMSE < 4.86 N). Device motion was highly repeatable for bench-top tests (ICC = 0.99) and participant trials (CMC = 1.00). Soft tissue response was found repeatable for intra (CMC > 0.98) and inter trials (CMC > 0.70). The device has been shown to be capable of implementing complex loading patterns similar to gait, and of capturing the compressive response of the plantar soft tissue for a range of loading conditions in vivo.

Detailed information about the biomechanical behaviour of plantar heel pad tissue contributes to our understanding of load transfer when the foot impacts the ground. The objective of this work was to obtain the hyperelastic and viscoelastic material properties of heel pad sub-layers (skin, micro-chamber and macro-chamber layers) in-vivo. An anatomically detailed 3D Finite Element model of the human heel was used to derive the sub-layer material properties. A combined ultrasound imaging and motorised platform system was used to compress heel pad and to create input data for the Finite Element model. The force-strain responses of the heel pad and its sub-layers under slow compression (5mm/s) and rapid loading-hold-unloading cycles (225mm/s), were measured and hyperelastic and viscoelastic properties of the three heel pad sub-layers were estimated by the model. The loaded (under ∼315N) thickness of the heel pad was measured from MR images and used for hyperelastic model validation. The capability of the model to predict peak plantar pressure was used for further validation. Experimental responses of the heel pad under different dynamic loading scenarios (loading-hold-unloading cycles at 141mm/s and sinusoidal loading with maximum velocity of 300mm/s) were used to validate the viscoelastic model. Good agreement was achieved between the predicted and experimental results for both hyperelastic (<6.4% unloaded thickness, 4.4% maximum peak plantar pressure) and viscoelastic (Root Mean Square errors for loading and unloading periods <14.7%, 5.8% maximum force) simulations. This paper provides the first definition of material properties for heel pad sub-layers by using in-vivo experimental force-strain data and an anatomically detailed 3D Finite Element model of the heel.

Background In-shoe pressure measurement systems are used in research and clinical practice to quantify areas and levels of pressure underfoot whilst shod. Their validity and reliability across different pressures, durations of load and contact areas determine their appropriateness to address different research questions or clinical assessments. XSENSOR is a relatively new pressure measurement device and warrants assessment. Research question Does the XSENSOR in-shoe pressure measurement device have sufficient validity and reliability for clinical assessments in diabetes? Methods Two XSENSOR insoles were examined across two days with two lab-based protocols to assess regional and whole insole loading. The whole insole protocol applied 50–600 kPa of pressure across the insole surface for 30 seconds and measured at 0, 2, 10 and 30 seconds. The regional protocol used two (3.14 and 15.9 cm2 surface area) cylinders to apply pressures of 50, 110 and 200 kPa to each insole. Three trials of all conditions were averaged. The validity (% difference and Root Mean Square Error: RMSE) and repeatability (Bland Altman, Intra-Class Correlation Coefficient: ICC) of the target pressures (whole insole) and contact area (regional) were outcome variables. Results Regional results demonstrated mean contact area errors of less than 1 cm2 for both insoles and high repeatability (≥0.939). Whole insole measurement error was higher at higher pressures but resulted in average peak and mean pressures error < 10%. Reliability error was 3–10% for peak pressure, within the 15% defined as an analytical goal. Significance Errors associated with the quantification of pressure are low enough that they are unlikely to influence the assessments of interventions or screening of the at-risk-foot considering clinically relevant thresholds. Contact area is accurate due to a high spatial resolution and the repeatability of the XSENSOR system likely makes it appropriate for clinical applications that require multiple assessments.

Background Peripheral vascular diseases have a significant impact on functional quality of life. Previous research has demonstrated the complex, limiting and costly economic implications of these conditions such as lower limb ulceration chronicity and ischaemic amputation. These complex, limb and life threatening conditions demand the development of novel interventions with objective research as part of that development. Hence, a novel intermittent negative pressure medical device in the form of a wearable boot (FlowOx™) was developed. As part of the development process, this study aimed to explore patient and clinician opinions of the boot. Methods A qualitative approach was used to collect patient and clinician experiences in Norway. An advisory group informed the semi-structured questions used in seven patient interviews and one clinician focus group (n = 5). The data were recorded digitally and transcribed verbatim. Patient and clinician data were analysed as distinct groups using a thematic process. Results Data analysis resulted in five themes from the patients which gave insight into; the impact of the disease process; practicalities of using the boot, positive experiences of use; perceived outcomes; reflecting on use. Six themes were created from the clinicians. These gave insight into; ideal outcomes and how to measure them; ways to potentially use the boot; using research in healthcare; positives of the device; observed effects and next steps; potential improvements to the device. Conclusion This study provides insight into the experiences and opinions of FlowOx™. Patients and clinicians were positive about the device due to its ease of use. Those patients with peripheral arterial disease experienced significantly more benefit, especially for ischaemic ulceration than those with a chronic venous condition. Clinicians placed value on the patient reported outcomes in the treatment decision-making process. This preliminary study into experiences of FlowOx™ use provides valuable feedback that will inform design modification and ongoing research into implementation points and prospective user groups. FlowOx™ demonstrates potential as a conservative therapy offering users a convenient, home use, self-care management solution for improving symptomatic peripheral arterial disease and quality of life.