{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T18:39:04Z","timestamp":1791052744326,"version":"4.1.0"},"reference-count":47,"publisher":"Public Library of Science (PLoS)","issue":"3","license":[{"start":{"date-parts":[[2021,3,4]],"date-time":"2021-03-04T00:00:00Z","timestamp":1614816000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"Background<\/jats:title>Elevated plantar pressures represent a significant risk factor for neuropathic diabetic foot (NDF) ulceration. Foot offloading, through custom-made insoles, is essential for prevention and healing of NDF ulcerations. Objective quantitative evaluation to design custom-made insoles is not a standard method. Aims: 1) to develop a novel quantitative-statistical framework (QSF) for the evaluation and design of the insoles\u2019 offloading performance through in-shoe pressure measurement; 2) to compare the pressure-relieving efficiency of traditional shape-based total contact customised insoles (TCCI) with a novel CAD-CAM approach by the QSF.<\/jats:p><\/jats:sec>Methods<\/jats:title>We recruited 30 neuropathic diabetic patients in cross-sectional study design. The risk-regions of interest (R-ROIs) and their areas with in-shoe peak pressure statistically \u2265200kPa were identified for each patients\u2019 foot as determined on the average of peak pressure maps ascertained per each stance phase. Repeated measures Friedman test compared R-ROIs\u2019 areas in three different walking condition: flat insole (FI); TCCI and CAD-CAM insoles.<\/jats:p><\/jats:sec>Results<\/jats:title>As compared with FI (20.6\u00b112.9 cm2<\/jats:sup>), both the TCCI (7\u00b18.7 cm2<\/jats:sup>) and the CAD-CAM (5.5\u00b17.3 cm2<\/jats:sup>) approaches provided a reduction of R-ROIs mean areas (p<0.0001). The CAD-CAM approach performed better than the TCCI with a mean pressure reduction of 37.3 kPa (15.6%) vs FI.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>The CAD-CAM strategy achieves better offloading performance than the traditional shape-only based approach. The introduced QSF provides a more rigorous method to the direct 200kPa cut-off approach outlined in the literature. It provides a statistically sound methodology to evaluate the offloading insoles design and subsequent monitoring steps. QSF allows the analysis of the whole foot\u2019s plantar surface, independently from a predetermined anatomical identification\/masking. QSF can provide a detailed description about how and where custom-made insole redistributes the underfoot pressure respect to the FI. Thus, its usefulness extends to the design step, helping to guide the modifications necessary to achieve optimal offloading insole performances.<\/jats:p><\/jats:sec>","DOI":"10.1371\/journal.pone.0247915","type":"journal-article","created":{"date-parts":[[2021,3,4]],"date-time":"2021-03-04T19:03:32Z","timestamp":1614884612000},"page":"e0247915","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":16,"title":["Data-driven CAD-CAM vs traditional total contact custom insoles: A novel quantitative-statistical framework for the evaluation of insoles offloading performance in diabetic foot"],"prefix":"10.1371","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6754-3603","authenticated-orcid":true,"given":"Moreno","family":"D\u2019Amico","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9106-8016","authenticated-orcid":true,"given":"Edyta","family":"Kinel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piero","family":"Roncoletta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Gnaldi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Celeste","family":"Ceppitelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federico","family":"Belli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Murdolo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristiana","family":"Vermigli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2021,3,4]]},"reference":[{"key":"pone.0247915.ref001","unstructured":"IDF Diabetes Atlas 9th edition Brussels, Belgium: 2019. 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