ArticlePloS one2021
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.
Article in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed, 15 citations in OpenAlex.
- To scan or not to scan? Comparing the effectiveness and cost differential of insoles manufactured from foam-box casts versus direct scans in treating musculoskeletal conditions of the foot and ankle: a double-blinded, randomised controlled trial.BMC musculoskeletal disorders · 2025Trial
- Hybrid Decision-Making Management for Material Selection in the Design of Wearable Pressure-Sensing Orthoses in Neurorehabilitation.Biomimetics (Basel, Switzerland) · 2026Article
- Recent Innovations in Footwear and the Role of Smart Footwear in Healthcare-A Survey.Sensors (Basel, Switzerland) · 2024Review
- Advancements in diabetic foot insoles: a comprehensive review of design, manufacturing, and performance evaluation.Frontiers in bioengineering and biotechnology · 2024Review
- Leg Length Discrepancy and Nonspecific Low Back Pain: 3-D Stereophotogrammetric Quantitative Posture Evaluation Confirms Positive Effects of Customized Heel-Lift Orthotics.Frontiers in bioengineering and biotechnology · 2021Article
- Design and evaluation of a custom contoured pneumatic insole for active plantar pressure offloading.Journal of rehabilitation and assistive technologies engineeringArticle
Corrections and comments
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Authors and funding
8 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundElevated 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.
methodsWe 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.
resultsAs 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.
conclusionsThe 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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