Moreno D'Amico1,2, Edyta Kinel3, Piero Roncoletta1, Andrea Gnaldi4, Celeste Ceppitelli5, Federico Belli6, Giuseppe Murdolo5, Cristiana Vermigli5. 1. SMART Lab (Skeleton Movement Analysis and Advanced Rehabilitation Technologies)-Bioengineering & Biomedicine Company Srl, Pescara, Italy. 2. Department of Neuroscience, Imaging and Clinical Sciences University G. D'Annunzio, Chieti-Pescara, Italy. 3. Department of Rehabilitation, Chair of Rehabilitation and Physiotherapy, University of Medical Sciences, Poznan, Poland. 4. Guantificio Altotiberino Ecosanit Calzature Snc, Anghiari, Italy. 5. Department of Medicine, Unit of Endocrinology and Metabolism, S. Maria della Misericordia, Perugia Hospital, Perugia, Italy. 6. Independent Researcher, Perugia, Italy.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
BACKGROUND: 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. METHODS: We recruited 30 neuropathic diabeticpatients 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. RESULTS: 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. CONCLUSIONS: 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.
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