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To develop anatomically layered polyurethane phantom models mimicking healthy and diabetic plantar soft tissues and evaluate the reliability and concurrent validity of four mechanical stiffness assessment tools, [MyotonPRO, Shore Durometer, IndentoPRO, and Tissue Compliance Meter (TCM)] against Shear Wave Elastography (SWE). Six regional phantom models (calcaneus, midfoot, forefoot) with skin, fat pad, fascia, and muscle layers were fabricated. SWE was performed in no-contact mode to eliminate surface compression, improving measurement consistency. A total of 162 configurations were tested under blinded and randomized conditions. Intra- and inter-rater reliability was assessed using ICCs; concurrent validity was evaluated via correlation and regression analyses with SWE. All devices demonstrated excellent reliability (ICC range: 0.88\u20130.99). SWE-derived stiffness was significantly higher in diabetic models, especially in the calcaneal and midfoot regions (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). IndentoPRO showed the highest correlation with SWE (r\u2009=\u20090.91), followed by MyotonPRO (r\u2009=\u20090.87), TCM (r\u2009=\u20090.85), and Durometer (r\u2009=\u20090.78). TCM exhibited the highest predictive value (R<jats:sup>2<\/jats:sup>\u2009=\u20090.502) and most consistent performance across diabetic regions. The developed phantom models offer a standardized platform for evaluating stiffness assessment tools. While SWE remains the reference standard, mechanical devices, particularly TCM and IndentoPRO, demonstrated valid and reproducible performance. This phantom-based approach holds promise for supporting medical device development, regulatory validation, and preclinical testing in diabetic foot biomechanics.<\/jats:p>","DOI":"10.1038\/s41598-025-21084-5","type":"journal-article","created":{"date-parts":[[2025,9,30]],"date-time":"2025-09-30T16:58:10Z","timestamp":1759251490000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Validation and reliability of mechanical stiffness assessment tools in multilayered polyurethane phantom models of healthy and diabetic plantar soft tissues"],"prefix":"10.1038","volume":"15","author":[{"given":"T\u00fclay","family":"\u00c7evik Sald\u0131ran","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Schleip","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katja","family":"Bartsch","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wolfgang","family":"Bauermeister","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Torsten","family":"Pohl","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Horstmann","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,9,30]]},"reference":[{"key":"21084_CR1","volume-title":"IDF Diabetes Atlas","author":"International Diabetes Federation","year":"2025","unstructured":"International Diabetes Federation. 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