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.

METHODS: This study, involving a series of N-of-1 trials, included 21 participants who had a history of neuropathic plantar forefoot ulcers. Participants were recruited from two public hospitals and one private podiatry clinic in Sydney, New South Wales, Australia. This trial is non-randomised and unblinded. Participants will be recruited from three sites, including two high-risk foot services and a private podiatry clinic in Sydney, Australia. Mobilemat™ and F-Scan® plantar pressure mapping systems by TekScan® (Boston, USA) will be used to measure barefoot and in-shoe plantar pressures. Participants' self-reports will be used to quantify the wearing period over a certain period of between 2 and 4 weeks during the trial. Participant preference toward footwear, insole design and quality-of-life-related information will be collected and analysed. The descriptive and inferential statistical analyses will be performed using IBM SPSS Statistics (version 27). And the software NVivo (version 12) will be utilised for the qualitative data analysis.

DISCUSSION: This is the first trial assessing footwear and insole interventions in people with diabetes by using a series of N-of-1 trials. Reporting self-declared wearing periods and participants' preferences on footwear style and aesthetics are the important approaches for this trial. Patient-centric device designs are the key to therapeutic outcomes, and this study is designed with that strategy in mind.