Abstract

Abstract

Abstract

Abstract

Abstract
Diabetic foot is a serious complication that poses significant risks for diabetic patients. The resulting reduction in protective sensitivity in the plantar region requires early detection to prevent ulceration and ultimately amputation. The primary method employed for evaluating this sensitivity loss is the 10 gf Semmes-Weinstein monofilament test, commonly used as a first-line procedure. However, the lack of calibration in existing devices often introduces decision errors due to unreliable feedback. In this article, the mechanical behavior of a monofilament was analytically modeled, seeking to promote awareness of the impact of different factors on clinical decisions. Furthermore, a new device for the automation of the metrological evaluation of the monofilament is described. Specific testing methodologies, used for the proposed equipment, are also described, creating a solid base for the establishment of future calibration guidelines. The obtained results showed that the tested monofilaments had a very high error compared to the 10 gf declared by the manufacturers. To improve the precision and reliability of assessing the sensitivity loss, the frequent metrological calibration of the monofilament is crucial. The integration of automated verification, simulation capabilities, and precise measurements shows great promise for diabetic patients, reducing the likelihood of adverse outcomes.

Abstract
Diabetic foot is a complication that carries a considerable risk in diabetic patients. The consequent loss of protective sensitivity in the lower limbs requires an early diagnosis due to the imminent possibility of ulceration or amputation of the affected limb. To assess the loss of protective sensitivity, the 10 gf Semmes-Weinstein (SW) monofilament is the most used first-line procedure. However, the used device is most often non-calibrated and its feedback can lead to decision errors. In this paper we present an equipment that is able to automatically conduct a metrological verification and evaluation of the 10 gf SW monofilament in the assessment of the loss of protective sensitivity. Additionally, the proposed equipment is able to simulate the practicioner's procedure, or can be used for training purposes, providing force-feedback information. After calibration, displacement vs. buckling force contours were plotted for three distinct monofilaments, confirming then ability of the equipment to provide fast, detailed and precise information.