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.
<h4>Background</h4>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-m...
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doaj-1a06fdc796c74eee8b784e9afec3edc42021-03-18T05:31:26ZengPublic Library of Science (PLoS)PLoS ONE1932-62032021-01-01163e024791510.1371/journal.pone.0247915Data-driven CAD-CAM vs traditional total contact custom insoles: A novel quantitative-statistical framework for the evaluation of insoles offloading performance in diabetic foot.Moreno D'AmicoEdyta KinelPiero RoncolettaAndrea GnaldiCeleste CeppitelliFederico BelliGiuseppe MurdoloCristiana Vermigli<h4>Background</h4>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' 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.<h4>Methods</h4>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 ≥200kPa were identified for each patients' foot as determined on the average of peak pressure maps ascertained per each stance phase. Repeated measures Friedman test compared R-ROIs' areas in three different walking condition: flat insole (FI); TCCI and CAD-CAM insoles.<h4>Results</h4>As compared with FI (20.6±12.9 cm2), both the TCCI (7±8.7 cm2) and the CAD-CAM (5.5±7.3 cm2) 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.<h4>Conclusions</h4>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's 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.https://doi.org/10.1371/journal.pone.0247915 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Moreno D'Amico Edyta Kinel Piero Roncoletta Andrea Gnaldi Celeste Ceppitelli Federico Belli Giuseppe Murdolo Cristiana Vermigli |
spellingShingle |
Moreno D'Amico Edyta Kinel Piero Roncoletta Andrea Gnaldi Celeste Ceppitelli Federico Belli Giuseppe Murdolo Cristiana Vermigli 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. PLoS ONE |
author_facet |
Moreno D'Amico Edyta Kinel Piero Roncoletta Andrea Gnaldi Celeste Ceppitelli Federico Belli Giuseppe Murdolo Cristiana Vermigli |
author_sort |
Moreno D'Amico |
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. |
title_short |
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. |
title_full |
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. |
title_fullStr |
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. |
title_full_unstemmed |
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. |
title_sort |
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. |
publisher |
Public Library of Science (PLoS) |
series |
PLoS ONE |
issn |
1932-6203 |
publishDate |
2021-01-01 |
description |
<h4>Background</h4>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' 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.<h4>Methods</h4>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 ≥200kPa were identified for each patients' foot as determined on the average of peak pressure maps ascertained per each stance phase. Repeated measures Friedman test compared R-ROIs' areas in three different walking condition: flat insole (FI); TCCI and CAD-CAM insoles.<h4>Results</h4>As compared with FI (20.6±12.9 cm2), both the TCCI (7±8.7 cm2) and the CAD-CAM (5.5±7.3 cm2) 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.<h4>Conclusions</h4>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's 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. |
url |
https://doi.org/10.1371/journal.pone.0247915 |
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