Search Results (397)

Diabetes mellitus often leads to peripheral neuropathy that compromises protective sensation in the feet and raises ulcer risk through mechanical overload. While prior research has introduced cellular-metamaterial-based shoe midsoles for dynamic plantar pressure redistribution, this study advances the field by delivering a complete, application-oriented workflow for physical prototyping and mechanical validation of such structures. Our pipeline integrates analytical synthesis of curved-beam unit cells, process calibration, and fabrication via thermoplastic polyurethane (TPU) fused-filament fabrication, producing customized, test-ready lattices suitable for future gait-simulation studies and in vivo assessment. Printed TPU tests showed a Young’s modulus of 44.5 MPa, ultimate tensile strength of 4.9 MPa, and strain at break ≈ 20% (Shore 84.5 A/37.2 D). The cellular unit’s compressive response was quantified by theoretical force-threshold estimates and controlled compression tests, enabling data-driven selection of unit cell geometry and arrangement for effective offloading. The response is rate-dependent: higher loading speed increases peak force and hysteresis, indicating that loading rate should be treated as a design parameter to tune dynamic behavior for the target application. Although the analytical model overestimates forces by roughly 50% on average relative to experiments, it accurately captures the influence of key geometric parameters on peak force. Accordingly, experimental data can identify cell strategic geometric parameters (i.e., Q), while the achievable maximum force can be predicted from the model by applying an appropriate correction factor. By connecting modeling, calibration, and experimental validation in one coherent path, the proposed workflow enables manufacturable lattices with controllable activation thresholds for plantar pressure redistribution and provides a practical bridge from concept to application. Full article

Background/Objectives: Skin temperature has been considered a physiological variable associated with the risk of pressure injuries. This systematic review analyzed the available evidence regarding the relationship between skin temperature and the development, progression, or prevention of pressure injuries in humans. Methods: A systematic search was conducted in the PubMed, Scopus, and Dimensions databases, including studies published between 2013 and 2023 in English or Spanish. PRISMA 2020 guidelines and EQUATOR network checklists (CONSORT, STROBE, CARE) were applied to assess methodological quality. Risk of bias was evaluated using RoB 2, ROBINS-I, ROBINS-E, and JBI tools. Results: The reviewed studies reported thermal variations in tissues subjected to sustained pressure, some of which preceded the appearance of visible clinical signs of tissue damage. However, methodological heterogeneity, lack of standardized thermal thresholds, and variability in measurement conditions limited the generalizability of the findings. Conclusions: Skin temperature may be associated with relevant pathophysiological mechanisms in the development of pressure injuries. Its measurement could complement traditional clinical tools, such as the Braden scale, enhancing early risk identification. More robust, multicenter, and standardized studies are needed to validate its clinical applicability. Full article

Diabetes is emerging as a significant health and societal concern globally, impacting both young and old populations. In individuals with diabetic foot ulcers (DFUs), the wound healing process is hindered due to abnormal glucose metabolism and chronic inflammation. Minor injuries, blisters, or pressure sores can develop into chronic ulcers, which, if left untreated, may lead to serious infections, tissue necrosis, and eventual amputation. Current management techniques include debridement, wound dressing, oxygen therapy, antibiotic therapy, topical application of antibiotics, and surgical skin grafting, which are used to manage diabetic wounds and foot ulcers. This review focuses on a hydrogel-based strategy for phase-wise targeting of DFUs, addressing sequential stages of diabetic wound healing: hemostasis, infection, inflammation, and proliferative/remodeling phases. Hydrogels have emerged as a promising wound care solution due to their unique properties in providing a suitable wound-healing microenvironment. We explore natural polymers, including hyaluronic acid, chitosan, cellulose derivatives, and synthetic polymers such as poly (ethylene glycol), poly (acrylic acid), poly (2-hydroxyethyl methacrylate, and poly (acrylamide), emphasizing their role in hydrogel fabrication to manage DFU through phase-dependent strategies. Recent innovations, including self-healing hydrogels, stimuli-responsive hydrogels, nanocomposite hydrogels, bioactive hydrogels, and 3D-printed hydrogels, demonstrate enhanced therapeutic potential, improving patient outcomes. This review further discusses the applicability of various hydrogels to each phase of wound healing in DFU treatment, highlighting their potential to advance diabetic wound care through targeted, phase-specific interventions. Full article

Background: Detailed assessments, documentation, and evaluation of the wound characteristics in hard-to-heal wounds are essential for optimizing and individualizing wound care. However, the remaining challenge in clinical care includes the lack of high accuracy and precision tools for automated wound size (surface area and depth assessment) and a wound bed evaluation, i.e., a qualitative and quantification assessment of slough and necrosis. Objective/Methods: This study evaluates the accuracy and precision of the AI-powered technique, SeeWound© 2, compared to digital planimetry for a wound surface area and a wound bed characterization (slough and necrosis) in “in vitro” models and in patients, and a probe for depth, including diabetic foot ulcers, venous ulcers, pressure ulcers, and ischemic ulcers. Results: The data show that accuracy and precision (SeeWound© 2) for the wound surface area, the depth, and the wound bed characterization (slough and necrosis) were accuracy 96.28% and 90.00%, (CV 5.56%), respectively (wound size); 90.75% and 89.55%, (CV 3.07%), respectively (wound depth); 80.30% (slough) and 84.73% (necrosis) and 93.51% (slough) (CV 4.15%) and 82.35% (CV 8.34%) (necrosis). The precision for the digital planimetry was 88.61% (CV 7.00%) (slough) 85.74% (CV 7.54%) (necrosis). Conclusions: The overall accuracy and precision of the AI model in identifying wound size and depth were close to 90%, except for the accuracy and precision for slough and necrosis, where levels around 80% were achieved when compared to digital planimetry. The findings for the wound surface area and depth assessments, together with quantification of slough and necrosis, suggest that the SeeWound© 2 model can offer significant clinical benefits by improving documentation and supporting decision-making in wound management. Full article

Pressure ulcers (PUs) are localized injuries caused by prolonged mechanical loading and ischemia, often leading to delayed healing and high recurrence rates. Although conventional treatments aim to support tissue repair, their efficacy remains limited, prompting interest in noninvasive therapies such as the pulsed electromagnetic field (PEMF). The PEMF has been reported to enhance cellular proliferation, re-epithelialization, and collagen remodeling, but its effects in pressure ulcer models, particularly concerning genetic background, remain unclear. This study investigated the therapeutic effects of the PEMF in a murine pressure ulcer model established by ischemia and reperfusion injury induced with externally attached magnets in two mouse strains, BALB/c and C57BL/6. The PEMF (10 Hz, 24 h per day) was used to treat PU-induced mice from day 4 to day 15 in BALB/c mice and to day 14 in C57BL/6 mice. Wound healing was assessed by gross morphological observation, histological analysis, and digital quantification of epidermal lesion length and collagen-positive area. In BALB/c mice, PEMF-treated wounds showed a modest trend toward improved re-epithelialization and collagen deposition, although the differences were not statistically significant. In contrast, C57BL/6 mice exhibited a significantly shorter length of epidermal lesion in the PEMF group on day 14, indicating enhanced epidermal regeneration. Collagen analysis showed comparable levels between treated and control groups in both strains, with no significant differences observed. To further assess the cellular response to PEMF, a scratch wound assay was conducted using HaCaT cells. Quantitative analysis demonstrated that PEMF treatment accelerated cell migration and wound closure in vitro. These findings suggest that PEMF enhances epidermal regeneration and keratinocyte mobility, with therapeutic responses potentially influenced by genetic background. This study supports the potential application of PEMF in pressure ulcer treatment and underscores the importance of strain selection in preclinical wound healing research. Full article

Background: Chronic wounds are a growing clinical challenge due to their prolonged healing time and associated healthcare burden. Combined therapeutic approaches, including topical oxygen therapy (TOT) and negative-pressure wound therapy (NPWT), have shown promise in enhancing wound healing. This pilot exploratory study aimed to assess the clinical effectiveness of combined TOT and NPWT in chronic wound treatment and to explore the prognostic value of selected laboratory and thermographic markers. Methods: Eighteen patients with chronic wounds due to type 2 diabetes mellitus or chronic venous insufficiency were treated with either TOT alone (control group) or TOT combined with NPWT (intervention group). Wound characteristics, thermographic data, and laboratory parameters (NLR, MLR, PLR, CRP, and total protein) were collected at baseline and during therapy. The primary endpoints were the total treatment duration and complete wound closure. Statistical analyses were exploratory and used non-parametric tests, correlation analyses, and simple linear regression. Results: Ulcer duration was significantly associated with the wound surface area. Lower serum total protein levels correlated negatively with ulcer duration, wound size, and granulation tissue area. A significant reduction in treatment duration was observed in the intervention group compared to the controls. One strong correlation was found between MLR and peripheral wound temperature on day 7 in the control group. No significant group differences were observed in wound size or thermographic measures after one week of treatment. Conclusions: Combining TOT and NPWT may reduce treatment duration in chronic wound management. Selected laboratory and thermographic markers show promise as prognostic tools. These exploratory findings require confirmation in larger, randomized trials. Full article

Background/Objectives: Pressure injuries are a significant concern among older adults, particularly in community-based long-term care settings where prolonged immobility is prevalent. This study aimed to identify factors influencing sacral interface pressure in community-dwelling older adults, with an emphasis on support surface usage and clinical risk indicators. Methods: A total of 210 participants aged 65 years and older, all receiving long-term care services in South Korea, were enrolled in this study. Sacral interface pressure was measured in the supine position using a portable pressure mapping device (Palm Q7). General characteristics, Braden Scale scores, Huhn Scale scores, and mattress usage were assessed. Data were analyzed using descriptive statistics, t-tests, chi-square tests, and logistic regression. Results: Mattress non-use was identified as the strongest predictor of elevated sacral interface pressure (OR = 6.71, p < 0.001), followed by Braden Scale scores indicating moderate risk (OR = 4.8, p = 0.006). Huhn Scale scores were not significantly associated with interface pressure. These results suggest that support surface quality and skin condition have a stronger impact on interface pressure than mobility-related risk factors. Conclusions: The findings highlight the importance of providing high-quality pressure-relieving mattresses and implementing standardized nursing assessments to reduce the risk of pressure injuries. Integrating smart technologies and expanding access to advanced support surfaces may aid in developing tailored preventive strategies for vulnerable older adults. Full article

Background/Objectives: Vedolizumab is a gut-selective anti-integrin monoclonal antibody approved for the treatment of inflammatory bowel disease (IBD). While clinical trials have demonstrated a favorable safety profile, real-world studies are essential for identifying rare adverse events (AEs) and evaluating post-marketing safety. This study assessed vedolizumab’s safety in a real-world cohort and supported the detection of potential safety signals. Methods: A retrospective chart review was conducted on adult IBD patients treated with vedolizumab at a tertiary center in the Republic of Serbia between October 2021 and August 2022. Data included demographics, AEs, and newly reported extraintestinal manifestations (EIMs). Exposure-adjusted incidence rates were calculated per 100 patient-years (PYs). Disproportionality analysis using the FDA Adverse Event Reporting System (FAERS) was performed to identify safety signals, employing reporting odds ratios (RORs) and proportional reporting ratios (PRRs) for AEs also observed in the cohort. Prior IBD therapies and reasons for discontinuation were evaluated. Results: A total of 107 patients (42.1% Crohn’s disease, 57.9% ulcerative colitis) were included, with a median vedolizumab exposure of 605 days. There were 92 AEs (56.51/100 PYs), most frequently infections (23.95/100 PYs), gastrointestinal disorders (4.30/100 PYs), and skin disorders (4.30/100 PYs). The most frequently reported preferred terms (PTs) included COVID-19, COVID-19 pneumonia, nephrolithiasis, and nasopharyngitis. Arthralgia (12.90/100 PYs) was the most frequent newly reported EIM. No discontinuations due to vedolizumab AEs occurred. FAERS analysis revealed potential signals for events not listed in prescribing information but observed in the cohort: nephrolithiasis, abdominal pain, diarrhea, malaise, cholangitis, gastrointestinal infection, blood pressure decreased, weight decreased, female genital tract fistula, respiratory symptom, and appendicectomy. Most patients had received three prior therapies, often stopping one due to AEs. Conclusions: Vedolizumab demonstrated a favorable safety profile in the IBD cohort. However, FAERS-identified signals, such as nephrolithiasis, gastrointestinal infections, and decreased blood pressure, warrant further investigation in larger, more diverse populations. Full article

Peripheral circulatory failure refers to a condition in which the blood flow through superficial capillaries is markedly reduced or completely occluded. In clinical practice, nurses strictly adhere to regular repositioning protocols to prevent peripheral circulatory failure, during which the skin condition is evaluated visually. In this study, skin colour changes resulting from pressure application were continuously captured using a camera, and supervised machine learning was employed to classify the data into two categories: before and after pressure. The evaluation of practical colour space components revealed that the h component of the JCh colour space demonstrated the highest discriminative performance (Area Under the Curve (AUC) = 0.88), followed by the a* component of the CIELAB colour space (AUC = 0.84) and the H component of the HSV colour space (AUC = 0.83). These findings demonstrate that it is feasible to quantitatively evaluate skin colour changes associated with pressure, suggesting that this approach can serve as a valuable indicator for dimensionality reduction in feature extraction for machine learning and is potentially an effective method for preventing pressure-induced skin injuries. Full article

The global healthcare system faces significant challenges posed by diabetes and its complications, highlighting the need for innovative strategies to improve early diagnosis and treatment. Machine learning models help in the early detection of diseases and recommendations for taking safety measures and treating the disease. A comparative analysis of existing machine learning (ML) models is necessary to identify the most suitable model while uniformly fixing the model parameters. Assessing risk based on biomarker measurement and computing overall risk is important for accurate prediction. Early prediction of complications that may arise, based on the risk of diabetes and biomarkers, using machine learning models, is key to helping patients. In this paper, a comparative model is presented to evaluate ML models based on common model characteristics. Additionally, a risk assessment model and a prediction model are presented to help predict the occurrence of complications. Random Forest (RF) is the best model for predicting the occurrence of Type 2 Diabetes (T2D) based on biomarker input. It has also been shown that the prediction of diabetes complications using neural networks is highly accurate, reaching a level of 98%. Full article

Background/Objectives: The Jackson/Cubbin scale is a recommended tool to assess the risk of pressure injury in intensive care unit (ICU) patients. This scale is deemed to have superior predictive validity compared to the Braden scale. Many Italian nurses struggle with reading and applying the tool in English. This language barrier results in a lack of use of the Jackson/Cubbin scale clinically, meaning that patients potentially experience worse outcomes. This study aims to translate the original English version of the Jackson/Cubbin scale into the Italian language, conduct a cultural adaptation, and verify its content validity. Methods: An observational study was conducted using Beaton’s five-step methodology: (1) forward translation, (2) synthesis, (3) back-translation, (4) expert committee approval using Fleiss’ Kappa (κ) index, and (5) pre-testing, where participants assessed item clarity on a dichotomous scale (clear/unclear). Items deemed unclear by 20% or more of the sample were revised. Content validity was assessed using the Content Validity Index (CVI). Results: Fleiss’ κ index was 0.74. Item 3 “PMH-affecting condition” was unclear to 36% of the sample and required revision. The item-level CVI (I-CVI) was >0.78 for each item. The scale-level CVI (S-CVI) and the scale-level CVI using the average method (S-CVI-Ave) were 0.92 and 0.94, respectively. Conclusions: The translation process resulted in a linguistically accurate scale requiring content modifications to reflect current evidence and reduce inter-rater variability. This may improve implementation of the Jackson/Cubbin scale in clinical practice for Italian nurses and reduce the incidence of pressure injury for ICU patients. Full article

Background: Pressure ulcers (PUs) remain a prevalent complication in intensive care unit (ICU) settings, especially among immobilized patients. The impact of structured, nursing-led mobilization protocols on PU prevention and recovery remains underexplored. Objective: To evaluate the impact of nursing-led mobilization protocols on the incidence and progression of PUs in critically ill patients. Methods: In this retrospective observational cohort study, 188 ICU patients were admitted during one of two consecutive periods of care: conventional care (6-hourly repositioning) and an advanced nursing-led protocol (3-hourly repositioning with support surfaces and specialized nurse training), which replaced conventional care as standard in our institution. The primary outcome included new PU development for patients with no pre-existing ulcers or worsening/non-progression of pre-existing ulcers at discharge; ICU mortality was evaluated as a secondary outcome. Results: Among patients without pre-existing ulcers (n = 155), new PU incidence did not significantly differ between groups, even after adjusting for SOFA score (OR 0.40, 95% CI: 0.05 TO 3.17; p = 0.374). However, in patients with pre-existing ulcers (n = 33), the advanced care group showed improvement (53.3% versus 0% in the conventional group, OR 0.07, 95% CI: 0.01–0.64; p = 0.012); this effect was independent of initial SOFA score. Mortality was associated with the SOFA score, but not with the type of care. Conclusions: While advanced nursing-led mobilization did not reduce PU incidence, it significantly improved existing ulcer outcomes. Findings support the integration of structured protocols for high-risk ICU patients, especially those with existing ulcers. 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

Chronic wounds, such as diabetic ulcers and pressure injuries, remain a major global health burden, affecting over 40 million people worldwide and imposing significant socioeconomic strain. Hydrogel-based wound dressings have gained clinical attention for their ability to maintain moisture, mimic the extracellular matrix, and support tissue regeneration. However, traditional hydrogels often lack the mechanical robustness, antimicrobial efficacy, and dynamic responsiveness needed to treat complex wound environments effectively. To address these limitations, nanohybrid hydrogels, composite systems that integrate functional nanomaterials into hydrogel matrices, have emerged as intelligent platforms for advanced wound care. These systems enable multifunctional therapeutic action, including antibacterial activity, antioxidant regulation, angiogenesis promotion, immune modulation, and stimuli-responsive drug delivery. This review synthesizes recent advances in nanohybrid hydrogel design, beginning with an overview of traditional polymeric systems and their constraints. We categorize functional mechanisms according to biological targets and classify nanohybrid architectures by material type, including metal-based nanoparticles, nanozymes, carbon-based nanomaterials, polymeric nanogels, and metal–organic frameworks. Representative studies are summarized in a comparative table, and challenges related to biosafety, clinical translation, and design optimization are discussed. Nanohybrid hydrogels represent a rapidly evolving frontier in wound care, offering bioresponsive, multifunctional platforms with the potential to transform chronic wound management. Full article

Chronic wounds, including diabetic foot ulcers and pressure sores, are becoming more prevalent due to aging populations and increased metabolic problems. These wounds often persist due to impaired healing, chronic inflammation, oxidative stress, and infections caused by multidrug-resistant pathogens, making conventional treatments—including antibiotics and antiseptics—largely inadequate. This creates an urgent need for advanced, biologically responsive therapies that can both combat infection and promote tissue regeneration. Probiotics have surfaced as a viable option owing to their capacity to regulate immune responses, impede pathogenic biofilms, and generate antibacterial and antioxidant metabolites. However, their clinical application is limited by poor viability, sensitivity to environmental conditions, and short retention at wound sites. Nanotechnology-based delivery systems address these limitations by protecting probiotics from degradation, enhancing site-specific delivery, and enabling controlled, stimuli-responsive release. Encapsulation techniques using materials like chitosan, PLGA, liposomes, nanogels, nanofibers, and microneedles have shown significant success in improving wound healing outcomes in preclinical and clinical models. This review summarizes the current landscape of chronic wound challenges and presents recent advances in probiotic-loaded nanotechnologies. It explores various nano-delivery systems, their mechanisms of action, biological effects, and therapeutic outcomes, highlighting the synergy between probiotics and nanocarriers as a novel, multifaceted strategy for managing chronic wounds. Full article