METHODS: In this prospective, randomised, proof-of-concept study, patients with diabetes, and with peripheral neuropathy and a recent history of plantar foot ulceration were recruited from two multidisciplinary outpatient diabetic foot clinics in the UK, and were randomly assigned to either intervention or control. All patients received an insole system, which measured plantar pressure continuously during daily life. The intervention group received audiovisual alerts via a smartwatch linked to the insole system and offloading instructions when aberrant pressures were detected; the control group did not receive any alerts. The primary outcome was plantar foot ulcer occurrence within 18 months. This trial is registered with ISRCTN, ISRCTN05585501, and is closed to accrual and complete.
FINDINGS: Between March 18, 2014, and Dec 20, 2016, 90 patients were recruited and consented to the study, and 58 completed the study. At follow-up, ten ulcers from 8638 person-days were recorded in the control group and four ulcers from 11 835 person-days in the intervention group: a 71% reduction in ulcer incidence in the intervention group compared with the control group (incidence rate ratio 0·29, 95% CI, 0·09-0·93; p=0·037). The number of patients who ulcerated was similar between groups (six of 26 [control group] vs four of 32 [intervention group]; p=0·29); however, individual plantar sites ulcerated more often in the control group (ten of 416) than in the intervention group (four of 512; p=0·047). In an exploratory analysis of good compliers (n=40), ulcer incidence was reduced by 86% in the intervention group versus control group (incidence rate ratio 0·14, 95% CI 0·03-0·63; p=0·011). In the exploratory analysis, plantar callus severity (change from baseline to 6 months) was greater in re-ulcerating patients (6·5, IQR 4·0-8·3) than non-re-ulcerating patients (2·0, 0·0-4·8; p=0·040).
INTERPRETATION: To our knowledge, this study is the first to show that continuous plantar pressure monitoring and dynamic offloading guidance, provided by an innovative intelligent insole system, can lead to a reduction in diabetic foot ulcer site recurrence.
FUNDING: Diabetes UK and Orpyx Medical Technologies.
Methods: Eighteen male subjects ran on three different surfaces (i.e., concrete, artificial grass, and rubber) in both heeled running shoes (HS) and minimal running shoes (MS). Both these shoes had dissimilar sole profiles. The heeled shoes had a higher sole at the heel, a thick base, and arch support, whereas the minimal shoes had a flat base sole. Indeed, the studied biomechanical parameters responded differently in the different footwear during running. Subjects ran in recreational mode speed while 3D foot kinematics (i.e., joint rotation and peak medial longitudinal arch (MLA) angle) were determined using a motion capture system (Qualysis, Gothenburg, Sweden). Information on stance time and plantar fascia strain (PFS) was also collected.
Results: Running on different surface stiffness was found to significantly affect the peak MLA angles and stance times for both HS and MS conditions. However, the results showed that the joint rotation angles were not sensitive to surface stiffness. Also, PFS showed no relationship with surface stiffness, as the results were varied as the surface stiffness was changed.
Conclusion: The surface stiffness significantly contributed towards the effects of peak MLA angle and stance time. These findings may enhance the understanding of biomechanical responses on various running surfaces stiffness in different shoe conditions.
OBJECTIVES:: To test the hypothesis that toe-out gait will reduce second peak knee adduction moment further and increase fall risk when combined with knee brace and laterally wedged insole in knee osteoarthritis patients.
STUDY DESIGN:: Single visit study with repeated measures.
METHODS:: First and second peak knee adduction moments, fall risk and comfort level. First and second peak knee adduction moments were determined from three-dimensional gait analysis, completed under six randomized conditions: (1) natural, (2) knee brace, (3) knee brace + toe-out gait, (4) laterally wedged insole, (5) laterally wedged insole + toe-out gait, and (6) knee brace + laterally wedged insole + toe-out gait. Fall risk was assessed by Biodex Balance System using three randomized stability settings: (1) static, (2) moderate dynamic setting (FR12), and (3) high dynamic setting (FR8).
RESULTS:: The reduction in first peak knee adduction moment and second peak knee adduction moment was greatest (7.16% and 25.55%, respectively) when toe-out gait combine with knee brace and laterally wedged insole. Significant increase in fall risk was observed with knee brace + laterally wedged insole + toe-out gait (42.85%) at FR12. Similar significant balance reductions were found at FR8 condition for knee brace + toe-out gait (35.71%), laterally wedged insole + toe-out gait (28.57%), and knee brace + laterally wedged insole + toe-out gait (50%) as compared to natural. However, knee brace decreased fall risk at FR12 by 28.57%.
CONCLUSION:: There is a synergistic effect of toe-out when combined with knee brace and laterally wedged insole concurrently in second peak knee adduction moment reduction but with a greater degree of fall risk. Simultaneous use of conservative treatments also decreases comfort level.
CLINICAL RELEVANCE: Patients with mild and moderate knee osteoarthritis are usually prescribed conservative treatment techniques. This study will provide an insight whether or not a combination of these techniques have a synergistic effect in reducing knee joint load.