Technical Feasibility of Custom-Fabricated Auxetic Foam Insoles for Plantar Pressure Redistribution: An Exploratory Pilot and Bootstrap Resampling Investigation
LaBreesha Batey, Enrique M. Jackson, Changchun Zeng, Selvum PillayPeripheral neuropathy degrades gait mechanics, elevating peak plantar pressures (PPP) and tissue ulceration risks. This exploratory pilot study evaluates custom orthotics using thermo-mechanically synthesized re-entrant auxetic foam insoles with targeted dome-shaped inserts. Bilateral dynamic gait analysis was conducted across a heterogeneous cohort (N = 9) utilizing a P-Walk 600 pressure plate and a MARVUE 2D motion capture system inside standardized footwear. To address small-sample limits, a non-parametric bootstrap resampling analysis (B = 1000) was executed. Native auxetic foam demonstrated high internal consistency ((σ*) = 12.063 kPa, Consistency Rank = 1), showing a strong numerical propensity to restrict load distribution variability compared to factory-installed over-the-counter (OTC) memory foam controls. While initial cell-adaptation cycles were observed, custom insoles reduced PPP by up to 62.2% in systemic polyneuropathies, shifting signatures beneath the exploratory clinical safety target (<200 kPa) in 55% of simulated cases. Conversely, customization triggered an adverse volumetric crowding effect in focal mononeuropathies, suggesting un-customized native auxetic foam as the preferred structural configuration for this specific cohort to avoid premature cell densification. Re-entrant cellular structures accommodate heterogeneous pathomechanics, offering an exploratory pathway for patient-specific orthotic optimization.