Footwear and insole design parameters to prevent occurrence and recurrence of neuropathic plantar forefoot ulcers in patients with diabetes: a series of N-of-1 trial study protocol

Trials

Study Protocol

Anita Sharma¹  Susan Nancarrow²  Sayed Ahmed²  Paul Butterworth²  Alex Barwick²  Md Zobaer Hasan³ 

[1] Department of Geriatric Medicine, Nepean Hospital, Penrith, New South Wales, Australia;Nepean Clinical School, Faculty of Medicine and Health, University of Sydney, Camperdown, New South Wales, Australia;School of Health and Human Sciences, Southern Cross University, 4225, Billinga, Queensland, Australia;School of Science, Monash University Malaysia, Jalan Lagoon Selatan, 47500, Bandar Sunway, Selangor Darul Ehsan, Malaysia;General Educational Development, Daffodil International University, Daffodil Smart City, Ashulia, Dhaka, Bangladesh;

关键词: Diabetes;    Polyneuropathy;    Foot ulcer;    Footwear;    Insoles;   

DOI  :  10.1186/s13063-022-06968-5

 received in 2022-05-07, accepted in 2022-11-28,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundFoot complications occur in conjunction with poorly controlled diabetes. Plantar forefoot ulceration contributes to partial amputation in unstable diabetics, and the risk increases with concomitant neuropathy. Reducing peak plantar forefoot pressure reduces ulcer occurrence and recurrence. Footwear and insoles are used to offload the neuropathic foot, but the success of offloading is dependent on patient adherence. This study aims to determine which design and modification features of footwear and insoles improve forefoot plantar pressure offloading and adherence in people with diabetes and neuropathy.MethodsThis 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.DiscussionThis 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.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000699965p. Registered on June 23, 2020

【 授权许可】

CC BY   
© The Author(s) 2022