{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,8]],"date-time":"2026-02-08T08:55:42Z","timestamp":1770540942536,"version":"3.49.0"},"reference-count":66,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2023,1,30]],"date-time":"2023-01-30T00:00:00Z","timestamp":1675036800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100007434","name":"Ag\u00eancia Nacional de Inova\u00e7\u00e3o","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100007434","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Public Health"],"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>The incidence of diabetic foot ulceration (DFU) is increasing worldwide. Therapeutic footwear is usually recommended in clinical practice for preventing foot ulcers in persons with diabetes. The project Science DiabetICC Footwear aims to develop innovative footwear to prevent DFU, specifically a shoe and sensor-based insole, which will allow for monitoring pressure, temperature, and humidity parameters.<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<\/jats:title><jats:p>This study presents a three-step protocol for the development and evaluation of this therapeutic footwear, specifically: (i) a first observational study will specify the user requirements and contexts of use; (ii) after the design solutions were developed for shoe and insole, the semi-functional prototypes will be evaluated against the initial requirements; (iii) and a pre-clinical study protocol will enable the evaluation of the final functional prototype. The eligible diabetic participants will be involved in each stage of product development. The data will be collected using interviews, clinical evaluation of the foot, 3D foot parameters and plantar pressure evaluation. This three-step protocol was defined according to the national and international legal requirements, ISO norms for medical devices development, and was also reviewed and approved by the Ethics Committee of the Health Sciences Research Unit: Nursing (UICISA: E) of the Nursing School of Coimbra (ESEnfC).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The involvement of end-users (diabetic patients) will enable the definition of user requirements and contexts of use to develop design solutions for the footwear. Those design solutions will be prototyped and evaluated by end-users to achieve the final design for therapeutic footwear. The final functional prototype will be evaluated in pre-clinical studies to ensure that the footwear meets all the requirements to move forward to clinical studies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>The three-step study outlined in this protocol will provide the necessary insights during the product development, ensuring this new therapeutic footwear's main functional and ergonomic features for DFU prevention.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fpubh.2023.1061383","type":"journal-article","created":{"date-parts":[[2023,1,30]],"date-time":"2023-01-30T05:35:15Z","timestamp":1675056915000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":10,"title":["A three step protocol for the development of an innovative footwear (shoe and sensor based insole) to prevent diabetic foot ulceration"],"prefix":"10.3389","volume":"11","author":[{"given":"Liliana B.","family":"Sousa","sequence":"first","affiliation":[]},{"given":"In\u00eas","family":"Almeida","sequence":"additional","affiliation":[]},{"given":"Rafael A.","family":"Bernardes","sequence":"additional","affiliation":[]},{"given":"Te\u00f3filo R.","family":"Leite","sequence":"additional","affiliation":[]},{"given":"Rui","family":"Negr\u00e3o","sequence":"additional","affiliation":[]},{"given":"Jo\u00e3o","family":"Ap\u00f3stolo","sequence":"additional","affiliation":[]},{"given":"Anabela","family":"Salgueiro-Oliveira","sequence":"additional","affiliation":[]},{"given":"Pedro","family":"Parreira","sequence":"additional","affiliation":[]}],"member":"1965","published-online":{"date-parts":[[2023,1,30]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"9502","DOI":"10.1186\/s12889-020-09502-x","article-title":"Trends in the incidence of diabetes mellitus: results from the Global Burden of Disease Study 2017 and implications for diabetes mellitus prevention","volume":"20","author":"Liu","year":"2020","journal-title":"BMC Public Health"},{"key":"B2","year":"2016","journal-title":"Global Report on Diabetes"},{"key":"B3","doi-asserted-by":"publisher","first-page":"624","DOI":"10.1016\/S2213-8587(15)00129-1","article-title":"Effects of diabetes definition on global surveillance of diabetes prevalence and diagnosis: a pooled analysis of 96 population-based studies with 331,288 participants","volume":"3","author":"Danaei","year":"2015","journal-title":"Lancet Diab Endocrinol."},{"key":"B4","year":"2017"},{"key":"B5","doi-asserted-by":"publisher","first-page":"e1002751","DOI":"10.1371\/journal.pmed.1002751","article-title":"Health system performance for people with diabetes in 28 low- and middle-income countries: a cross-sectional study of nationally representative surveys","volume":"16","author":"Manne-Goehler","year":"2019","journal-title":"PLoS Med."},{"key":"B6","first-page":"168","article-title":"P\u00e9 Diab\u00e9tico: doen\u00e7a complexa, abordagem simples","volume":"8","author":"Ferreira","year":"2013","journal-title":"Revista Portuguesa de Diabetes."},{"key":"B7","doi-asserted-by":"publisher","first-page":"10","DOI":"10.5603\/EP.2015.0003","article-title":"Risk factors of diabetic foot of neuropathic origin in patients with type 2 diabetes","volume":"66","author":"Nehring","year":"2015","journal-title":"Endokrynol Pol."},{"key":"B8","doi-asserted-by":"publisher","first-page":"99","DOI":"10.1002\/dmrr.2702","article-title":"Footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in patients with diabetes: a systematic review","volume":"32","author":"Bus","year":"2016","journal-title":"Diabetes Metab Res Rev."},{"key":"B9","doi-asserted-by":"publisher","first-page":"4","DOI":"10.1002\/edm2.132","article-title":"Footwear and insole design features for offloading the diabetic at risk foot\u2014A systematic review and meta-analyses","volume":"11","author":"Collings","year":"2020","journal-title":"Endocrinol Diab Metabol"},{"key":"B10","doi-asserted-by":"publisher","first-page":"391","DOI":"10.1016\/j.jdiacomp.2013.03.001","article-title":"The effectiveness of footwear as an intervention to prevent or to reduce biomechanical risk factors associated with diabetic foot ulceration: a systematic review","volume":"27","author":"Healy","year":"2013","journal-title":"J Diabetes Complications."},{"key":"B11","doi-asserted-by":"publisher","first-page":"236","DOI":"10.11124\/JBISRIR-2016-003013","article-title":"Effectiveness of offloading methods in preventing primary diabetic foot ulcers in adults with diabetes. 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