Search Results (60)

Diabetic foot ulcers (DFUs) are a serious complication of diabetes, associated with high recurrence and amputation rates. Adherence to offloading devices is critical for wound healing but remains inadequately monitored in real-world settings. This study evaluates the SmartBoot edge-computing system—a wearable, real-time remote monitoring solution integrating an inertial measurement unit (Sensoria Core) and smartwatch—for its validity in quantifying cadence and step count as digital biomarkers of frailty, and for detecting adherence. Twelve healthy adults wore two types of removable offloading boots (Össur and Foot Defender) during walking tasks at varied speeds; system outputs were validated against a gold-standard wearable and compared with staff-recorded adherence logs. Additionally, user experience was assessed using the Technology Acceptance Model (TAM) in healthy participants (n = 12) and patients with DFU (n = 81). The SmartBoot demonstrated high accuracy in cadence and step count across conditions (bias < 5.5%), with an adherence detection accuracy of 96% (Össur) and 97% (Foot Defender). TAM results indicated strong user acceptance and perceived ease of use across both cohorts. These findings support the SmartBoot system’s potential as a valid, scalable solution for real-time remote monitoring of adherence and mobility in DFU management. Further clinical validation in ongoing studies involving DFU patients is underway. Full article

Diabetic foot ulcers (DFUs), which affect approximately 15% of individuals with diabetes mellitus (DM), result from complex molecular disturbances involving chronic hyperglycemia, immune dysfunction, and infection. At the molecular level, chronic hyperglycemia promotes the formation of advanced glycation end products (AGEs), activates the AGE-RAGE-NF-κB axis, increases oxidative stress, and impairs macrophage polarization from the pro-inflammatory M1 to the reparative M2 phenotype, collectively disrupting normal wound healing processes. The local wound environment is further worsened by antibiotic-resistant polymicrobial infections, which sustain inflammatory signaling and promote extracellular matrix degradation. The rising threat of antimicrobial resistance complicates infection management even further. Recent studies emphasize that optimal glycemic control using antihyperglycemic agents such as metformin, Glucagon-like Peptide 1 receptor agonists (GLP-1 receptor agonists), and Dipeptidyl Peptidase 4 enzyme inhibitors (DPP-4 inhibitors) improves overall metabolic balance. These agents also influence angiogenesis, inflammation, and tissue regeneration through pathways including AMP-activated protein kinase (AMPK), mechanistic target of rapamycin (mTOR), and vascular endothelial growth factor (VEGF) signaling. Evidence indicates that maintaining glycemic stability through continuous glucose monitoring (CGM) and adherence to antihyperglycemic treatment enhances antibiotic effectiveness by improving immune cell function and reducing bacterial virulence. This review consolidates current molecular evidence on the combined effects of glycemic and antibiotic therapies in DFUs. It advocates for an integrated approach that addresses both metabolic and microbial factors to restore wound homeostasis and minimize the risk of severe outcomes such as amputation. Full article

Diabetic foot ulcers (DFUs) represent a critical global health issue, necessitating the development of advanced smart, flexible, and wearable sensors for continuous monitoring that are reimbursable within foot orthotics. This study presents the design and characterization of a pressure sensor implemented into a shoe insole to monitor diabetic wound pressures, emphasizing the need for a high sensitivity, durability under cyclic mechanical loading, and a rapid response time. This investigation focuses on the electrical and mechanical properties of carbon nanotube (CNT) composites utilizing Ecoflex and polydimethylsiloxane (PDMS). Morphological characterization was conducted using Transmission Electron Microscopy (TEM), Laser Confocal Microscopy, and Scanning Electron Microscopy (SEM). The electrical and mechanical properties of the CNT/Ecoflex- and the CNT/PDMS-based sensor composites were then investigated. CNT/Ecoflex was then further evaluated due to its lower variability performance between cycles at the same pressure, as well as its consistently higher capacitance values across all trials in comparison to CNT/PDMS. The CNT/Ecoflex composite sensor showed a high sensitivity (2.38 to 3.40 kPa⁻¹) over a pressure sensing range of 0 to 68.95 kPa. The sensor’s stability was further assessed under applied pressures simulating human weight. A custom insole prototype, incorporating 12 CNT/Ecoflex elastomeric matrix-based sensors (as an example) distributed across the metatarsal heads, midfoot, and heel regions, was developed and characterized. Capacitance measurements, ranging from 0.25 pF to 60 pF, were obtained across N = 3 feasibility trials, demonstrating the sensor’s response to varying pressure conditions linked to different body weights. These results highlight the potential of this flexible insole prototype for precise and real-time plantar surface monitoring, offering an approachable avenue for a challenging diabetic orthotics application. Full article

Background and Clinical Significance: Kaposi sarcoma (KS) is a rare angio-proliferative mesenchymal tumor that predominantly affects the skin and mucous membranes but may involve lymph nodes and visceral organs. Clinically, it manifests as red-purple-brown papules, nodules, or plaques, either painless or painful, often with disfiguring potential. The diagnosis is traditionally based on clinical and histopathological evaluation, although non-invasive imaging techniques are increasingly used to support diagnosis and treatment monitoring. We report a case of HHV-8-negative Kaposi sarcoma evaluated with multiple non-invasive imaging modalities to highlight their diagnostic utility. Case Presentation: An 83-year-old man presented with multiple painful, violaceous papulo-nodular lesions, some ulcerated, on the lateral aspect of his left foot. Dermoscopy revealed the characteristic rainbow pattern. Dynamic Optical Coherence Tomography (D-OCT) allowed real-time visualization of microvascular abnormalities, identifying large serpentine and branching vessels with clearly delineated capsules. Line-field Optical Coherence Tomography (LC-OCT) showed irregular dermal collagen, vascular lacunae, and the presence of spindle cells and slit-like vessels. Histological analysis confirmed the diagnosis of Kaposi sarcoma, revealing a proliferation of spindle-shaped endothelial cells forming angulated vascular spaces, with red blood cell extravasation and a mixed inflammatory infiltrate. Conclusions: Non-invasive imaging tools, including dermoscopy, D-OCT, and LC-OCT, have emerged as valuable adjuncts in the diagnosis and monitoring of KS. These techniques enable in vivo assessment of vascular architecture and tissue morphology, enhancing clinical decision-making while reducing the need for immediate biopsy. Dermoscopy reveals polychromatic vascular features, such as the rainbow pattern, while D-OCT and LC-OCT provide high-resolution insights into vascular proliferation, tissue heterogeneity, and cellular morphology. Dermoscopy, dynamic OCT, and LC-OCT represent promising non-invasive diagnostic tools for the assessment of Kaposi sarcoma. These technologies provide detailed morphological and vascular information, enabling earlier diagnosis and more personalized management. While histopathology remains the gold standard, non-invasive imaging offers a valuable complementary approach for diagnosis and follow-up, particularly in complex or atypical presentations. Ongoing research and technological refinement are essential to improve accessibility and clinical applicability. Full article

Background: Chronic diabetic foot ulcers are a global health challenge, affecting approximately 18.6 million individuals each year. The timely and accurate prediction of wound healing paths is crucial for improving treatment outcomes and reducing complications. Methods: In this study, we apply predictive modeling to the case study of diabetic foot ulcers, analyzing and comparing multiple models based on Deep Neural Networks (DNNs) and Machine Learning (ML) algorithms to enhance wound prognosis and clinical decision making. Our approach leverages a dataset of 1766 diabetic foot wounds, each monitored for at least three visits, incorporating key clinical wound features such as WBP scores, wound area, depth, and tissue status. Results: Among the 12 models evaluated, the highest accuracy (80%) was achieved using a three-layer LSTM recurrent DNN trained on wound instances with four visits. The model performance was assessed through AUC (0.85), recall (0.80), precision (0.79), and F1-score (0.80). Our findings indicate that the wound depth and area at the first visit followed by the wound area and granulated tissue percentage at the second visit are the most influential factors in predicting the wound status. Conclusions: As future developments, we started building a weakly supervised semantic segmentation model that classifies wound tissues into necrosis, slough, and granulation, using tissue color proportions to further improve model performance. This research underscores the potential of predictive modeling in chronic wound management, specifically in the case of diabetic foot ulcers, offering a tool that can be seamlessly integrated into routine clinical practice. Full article

Background/Objectives: Due to poor perfusion, diabetic foot ulcers (DFUs) create hypoxic environments, and their chronicity represents a negative factor in wound healing. Transcutaneous oxygen pressure (TcPO₂) is a non-invasive method that provides information on oxygen supply to microvascular circulation, useful for determining the severity and progression of peripheral arterial disease (PAD) as well as potentially predicting DFU healing. However, the current literature does not provide strong support for the use of TcPO₂ as an independent predictive tool. Methods: This protocol aims to systematically review the available evidence according to PRISMA (2020) guidelines, registered with the International Prospective Register of Systematic Reviews (registration number: CRD42024505907). The following databases will be used: Cochrane Library, EMBASE, Ovid Medline, PubMed, and Web of Science. Additionally, a manual search will be conducted through the references of the included articles. Results: The systematic review will summarize the current evidence on the prognostic value of TcPO₂ in DFU healing, identifying gaps in knowledge and potential areas for future research. Conclusions: The findings of this study may clarify the prognostic value of TcPO₂ in DFU healing, which could ultimately facilitate clinical management, decision-making, patient care, and potentially reduce treatment costs. Full article

A chronic wound is a wound that fails to progress through the normal stages of healing within a typical time frame, often remaining open and unhealed for more than 4 to 6 weeks. The delayed healing is often associated with comorbidities, and its clinical consequences have posed great concern to patients, caregivers, and researchers. The use of electrostimulation to enhance healing in chronic wounds has received attention in the last 20 years. Innovative wearable electroceutical devices are engineered to enhance the healing of chronic wounds while prioritizing patient convenience. These devices employ controlled micro-electrostimulation to reactivate endogenous bioelectric activities needed for cellular signaling. However, these devices and their mechanisms of electrostimulation have not been fully explored. In this systematic review, three databases with articles published between 2000 and 2023 were searched and screened using strict inclusion criteria while adhering to the PRISMA checklist. We identified direct, pulsed, and alternating electric currents as the primary modalities by electroceutical devices to deliver electrical stimulation in chronic wounds. Typical chronic wounds identified include diabetic foot ulcers, pressure ulcers, and diabetic venous ulcers. Additionally, a few materials crucial for chronic wound healing were reviewed, and recent devices in research were considered in this study. Various devices, including triboelectric and piezo-nanogenerators, were identified for their potential functionalities in generating electrical stimulation relevant to chronic wound applications. The literature lacked closed-loop electroceutical platforms for treatment and concurrent monitoring of wound healing. The analysis taken from this systematic review provides opportunities at the intersection of epidermal soft bioelectronics, wound care, and remote sensing. Full article

Diabetic Foot Ulcers (DFUs) are a significant health and economic burden, potentially leading to limb amputation, with a severe impact on a person’s quality of life. During active movements like gait, the monitoring of shear has been suggested as an important factor for effective prevention of DFUs. It is proposed that, in textiles, strain can be measured as a proxy for shear stress at the skin. This paper presents the conceptualisation and development of a novel strain-sensing approach that can be unobtrusively integrated within sock textiles and worn within the shoe. Working with close clinical and patient engagement, a sensor specification was identified, and 12 load-sensing approaches for the prevention of DFU were evaluated. A lead concept using a conductive adhesive was selected for further development. The method was developed using a Lycra sample, before being translated onto a knitted ‘sock’ substrate. The resultant strain sensor can be integrated within mass-produced textiles fabricated using industrial knitting machines. A case-study was used to demonstrate a proof-of-concept version of the strain sensor, which changes resistance with applied mechanical strain. A range of static and dynamic laboratory testing was used to assess the sensor’s performance, which demonstrated a resolution of 0.013 $\mathrm{\Omega }$ across a range of 0–430 $\mathrm{\Omega }$ and a range of interest of 0–20 $\mathrm{\Omega }$. In cyclic testing, the sensor exhibited a cyclic strain threshold of 6% and a sensitivity gradient of 0.3 ± 0.02, with a low dynamic drift of 0.039 to 0.045% of the total range. Overall, this work demonstrates a viable textile-based strain sensor capable of integration within worn knitted structures. It provides a promising first step towards developing a sock-based strain sensor for the prevention of DFU formation. Full article

Background: Diabetic foot ulcers (DFUs) represent a significant challenge in managing diabetes, leading to higher patient complications and increased healthcare costs. Traditional approaches, such as manual wound assessment and diagnostic tool usage, often require significant resources, including skilled clinicians, specialized equipment, and extensive time. Artificial intelligence (AI) and generative AI offer promising solutions for improving DFU management. This study systematically reviews the role of AI in DFU classification, prediction, segmentation, and detection. Furthermore, it highlights the role of generative AI in overcoming data scarcity and potential of AI-based smartphone applications for remote monitoring and diagnosis. Methods: A systematic literature review was conducted following the PRISMA guidelines. Relevant studies published between 2020 and 2025 were identified from databases including PubMed, IEEE Xplore, Scopus, and Web of Science. The review focused on AI and generative AI applications in DFU and excluded non-DFU-related medical imaging articles. Results: This study indicates that AI-powered models have significantly improved DFU classification accuracy, early detection, and predictive modeling. Generative AI techniques, such as GANs and diffusion models, have demonstrated potential in addressing dataset limitations by generating synthetic DFU images. Additionally, AI-powered smartphone applications provide cost-effective solutions for DFU monitoring, potentially improving diagnosis. Conclusions: AI and generative AI are transforming DFU management by enhancing diagnostic accuracy and predictive capabilities. Future research should prioritize explainable AI frameworks and diverse datasets for AI-driven healthcare solutions to facilitate broader clinical adoption. Full article

Diabetic foot ulcers have an enormous impact on patients’ quality of life and represent a major economic burden. The cause is delayed and incomplete wound healing due to hyperglycemia, reduced blood flow, infections, oxidative stress and chronic inflammation. Plasma-activated water (PAW) is emerging as a new therapeutic approach in wound treatment, as it has many of the advantages of cold atmospheric plasma but is easier to apply, thus allowing for widespread use. The aim of this study was to investigate the potential of PAW to improve wound healing in diabetic rats, with a focus on uncovering the underlying mechanisms. Two full-thickness wounds in control and diabetic animals were treated with PAW, and healing was monitored for 15 days at five time points. PAW improved wound healing in diabetic rats and mainly affected the inflammatory phase of wound healing. Application of PAW decreased the number of inflammatory cells, myeloperoxidase (MPO) and N-acetyl-b-D-glycosaminidase (NAG) activity, as well as the mRNA expression of proinflammatory genes in diabetic rats. Ten days after injury, PAW treatment increased collagen deposition in the diabetic animals by almost 10% without affecting collagen mRNA expression, and this is in correlation with a decrease in the Mmp-9/Timp-1 ratio. In conclusion, PAW treatment affects wound healing by reducing the inflammatory response and influencing extracellular matrix turnover, suggesting that it has great potential to accelerate the healing of diabetic wounds. Full article

Background: Diabetic foot ulcers are a common complication of diabetes mellitus, often leading to progressive sensory deficits, impaired vascularization, and a predisposition to ulceration and gangrene. Untreated ulcers may cause recurrent infections that endanger a patient’s life. Amputation of part of the limb up to a well-vascularized level is one of the treatments employed for untreated ulcers. Objectives: Laboratory data were analyzed with the aim of identifying risk factors related to surgical amputation treatment of diabetic foot. We believe it is useful to identify risk factors that can be altered from a reversible condition in the clinical decision-making of treatment, thus manifesting themselves in a timely manner to provide the patient with an alternative to surgical amputation of the lower limb. Methods: Our retrospective study was conducted by the Department of Orthopedics and Traumatology at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome. We recruited 200 patients who underwent lower limb amputation for diabetic foot between 2017 and 2021 and had blood tests both 30 days and within 5 days before the first surgery. Results: This case–control study revealed a significant negative correlation between hemoglobin (Hb) levels and the occurrence of leg amputations. In contrast, C-reactive protein (CRP) levels, the neutrophil-to-lymphocyte ratio (NLR), and the platelet-to-lymphocyte ratio (PLR) showed significant positive correlations with leg amputations. A 3-year follow-up of the cases also revealed a significative positive correlation between age, white blood cells (WBC) count, NLR, PLR, and death at 3 years. Conclusions: Our findings suggested that lower Hb levels and elevated CRP, NLR, and PLR levels in patients with diabetic foot disease may be associated with a higher risk of lower-limb amputation. Unexpectedly, this study also demonstrated that elderly age, WBC, CRP, NLR and PLR levels may be associated with a negative prognosis for these patients. These findings highlighted the importance of monitoring these laboratory values in diabetic patients to identify individuals at higher risk of leg amputations and implement appropriate interventions to prevent or minimize the occurrence of this severe complication. Full article

The prevention of diabetic foot ulcers remains a critical challenge. This study evaluates a smart compression sock designed to address this issue by integrating temperature, plantar pressure, and blood oxygen sensors and monitoring data recorded by these sensors. The smart sock, developed with input from a certified Pedorthist, was tested on 20 healthy adult participants aged 16 to 53. It includes four temperature sensors and pressure sensors at common ulcer sites (first and fifth metatarsal heads, calcaneus, and hallux), and a blood oxygen sensor on the hallux. The sensors are monitored, and their transduced data are collected and stored through an app installed on a personal cell phone. The mobile app interface is user-friendly, providing intuitive navigation and easy access to the sensors’ data. Using repeated measures ANOVA and post hoc tests, we analyzed the impact of various physical activities on physiological changes in the foot. The device effectively detected significant variations in blood oxygen, temperature, and pressure across six activities. Statistical analyses revealed significant differences based on activity type and sensor location. These results highlight the smart sock’s sensitivity and accuracy, suggesting its potential to prevent diabetic foot ulcers. Further clinical trials are needed to evaluate its efficacy in a larger, more diverse population. Full article

This work describes a self-powered wireless temperature sensor platform that can be used for foot ulceration monitoring for diabetic patients. The proposed self-powered sensor platform consists of a piezoelectric bimorph, a power conditioning circuit, a temperature sensor readout circuit, and a wireless module. The piezoelectric bimorph mounted inside the shoe effectively converts the foot movement into electric energy that can power the entire sensor platform. Furthermore, a sensor platform was designed, considering the energy requirement of 4.826 mJ for transmitting one data packet of 18 bytes. The self-powered sensor platform prototype was evaluated with five test subjects with different weights and foot shapes; the test results show the subjects had to walk an average of 119.6 s to transmit the first data packet and an additional average of 71.2 s to transmit the subsequent data packet. The temperature sensor showed a resolution of 0.1 °C and a sensitivity of 56.7 mV/°C with a power conditioning circuit efficiency of 74.5%. Full article

One of the most significant complications of diabetes mellitus is diabetic sensory neuropathy. A reduction in pain perception increases the risk of diabetic patients developing foot ulcers and requiring amputation, which in turn results in impaired mobility and a diminished quality of life. Despite recent advances in our understanding of the aetiology of diabetic foot ulcers (DFUs), there remains a significant gap in the clinical prevention and management of these ulcers. Given that inflammation represents the initial stage in the formation of skin wounds, the utilisation of infrared thermography for the early detection of inflammatory tissue, the analysis of plantar pressures and the monitoring of controlled physical activity (PA) may facilitate the close observation of plantar skin alterations that are susceptible to the development of DFUs, thereby enabling the implementation of timely interventions such as personalised PA for these patients. It is recommended that an integrated approach be adopted which encompasses the utilisation of all emerging technologies in order to enhance outcomes in the prevention and management of DFUs. The aim of this study is to examine the existing literature on the relationship between temperature, pressure and physical activity in the diabetic foot. To this end, a systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) format across the PubMed, Scopus and Web of Science databases, with no temporal restriction. A total of 14 studies were included in the review. The use of infrared thermography for the early detection of inflammatory tissue, plantar pressures and the monitoring of controlled PA can facilitate the close monitoring of changes that may pose a risk for the formation of UFDs and provide timely intervention, thereby personalising the PA of the diabetic patient. Full article

This review summarizes studies dedicated to the assessment of microvascular function based on microcirculatory oscillations monitored by the Flow-Mediated Skin Fluorescence (FMSF) technique. Two approaches are presented. The first approach uses oscillatory parameters measured under normoxic conditions, expressed as flowmotion (FM), vasomotion (VM), and the normoxia oscillatory index (NOI). These parameters have been used for the identification of impaired microcirculatory oscillations associated with intense physical exercise, post-COVID syndrome, psychological stress, and erectile dysfunction. The second approach involves characterization of the microcirculatory response to hypoxia based on the measurement of hypoxia sensitivity (HS). The HS parameter is used to characterize microvascular complications in diabetes, such as diabetic kidney disease and diabetic foot ulcers. Based on research conducted by the authors of this review, the FMSF parameter ranges characterizing microvascular function are presented. The diagnostic approach to assessing microvascular function based on flowmotion monitored by the FMSF technique has a wide range of applications and the potential to be integrated into widespread medical practice. Full article