Infected Diabetic Foot Ulcers Research Articles

A Systematic Review of Randomized Controlled Trials of Antibiotic Use in Diabetic Foot Ulcer Infections: Focus on Clinical Cure.

BackgroundThe use of antibiotics in diabetic foot ulcer infections (DFUI) is essential in reducing morbidity. Optimal administration of antibiotics can improve clinical outcomes and reduce the risk of antibiotic resistance. This study aims to review the efficacy, in terms of clinical cure, of various regimens and the duration of antibiotic administration in DFUI patients, based on Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. The efficacy based on microbiological response is also reviewed as the secondary outcome.Materials and MethodsWe used three databases, namely PubMed, Scopus, and ScienceDirect, to search for randomized controlled trials (RCTs) in patients with DFUI who required antibiotics.ResultsA total of 16 studies were included in the systematic review. The study locations and bacterial patterns varied, with the most common pathogen being Staphylococcus aureus. Most studies did not demonstrate a significant difference in clinical cure and pathogen eradication, either in the comparison between systemic and topical antibiotics or in the duration of administration. Some studies had similar characteristics and were analyzed to conclude. These studies showed that ertapenem had comparable efficacy to piperacillin/tazobactam. Similar results were also conducted from studies of piperacillin-tazobactam+amoxicillin-clavulanic acid vs. moxifloxacin.ConclusionMost studies have heterogeneous characteristics, possibly due to differences in research location. Therefore, there is no strong evidence to recommend a specific antibiotic with the highest efficacy. However, since all included studies are RCTs, this review provides a good summary in considering antibiotic choices when treating DFUI patients.

Clinical Grading of Diabetic Foot Ulcer Infection and its Predictors among Type 2 Diabetes Mellitus Patients: A Cross-sectional Study

Introduction: Globally, about 425 million people are living with diabetes mellitus. Diabetic Foot Ulcers (DFU) are one of the severe complications of poorly controlled diabetes and over the time, about 50% of DFUs become infected which may require hospitalization. Aim: To find out the DFU infection severity pattern and its predictors among T2DM patients. Materials and Methods: This cross-sectional study was conducted at Integrated Diabetes and Gestational Diabetes Clinic (IDGDC), IQ City Medical College and Multispecialty Hospital, Durgapur, West Bengal, India, among Type 2 Diabetes Mellitus (T2DM) patients from June 2018 to November 2018. Total 1534 T2DM patients attended IDGDC during data collection period of 4 months and 132 of them had diabetic foot ulcer. After taking written informed consent, detailed data were collected from 132 of study participants using predesigned, semi structured and pre tested schedule developed with the help of Infectious Disease Society of America (IDSA) and International Working Group on the Diabetic Foot (IWGDF/ IDSA) classification system. Socio-demographic characteristic like age, sex, education, residence were recorded along with clinical data like glycated haemoglobin (HbA1c), duration of diabetes, treatment modalities Anthropometric measurements were taken as per World Health Organization (WHO) guidelines. T2DM was defined and classified as per American Diabetes Association (ADA) Guidelines. DFU infection severity was classified into uninfected, mild infection, moderate infection and severe infection as per IWGDF/IDSA guidelines. Chi-square test was used to show association between categorical variable. One-way Analysis of Variance (ANOVA) with Tukey's post-hoc test was used to show association between mean HbA1c level and DFU infection severity. The p-value ≤0.5 was considered significant. Results: Proportion of DFU was found to be 8.6%. As per the IWGDF/IDSA classification of DFU infection severity was found to be moderate in 59 (44.7%) of the study participants and mild in 32 (24.2%) of the study participants. 22 (16.7%) of study subjects had severe infection and required hospitalization for optimal care. Only 14.4% of study subjects did not have DFU infection. Increasing age (p-value=0.023), rural residence (p-value=0.015), poor education (p-value=0.001), obesity (p-value=0.001), central obesity (p-value=0.001), longer duration of diabetes (p-value=0.028), and poor glycemic control (p-value=0.001) was found to be significant risk factors for severe infection in DFU. Conclusion: Routine clinical assessment of DFU infection may help in making clinical decision of treatment modalities and help in saving lower limb as well as life of people with T2DM.

Classification of Infection and Ischemia in Diabetic Foot Ulcers Using VGG Architectures.

Diabetic foot ulceration (DFU) is a serious complication of diabetes, and a major challenge for healthcare systems around the world. Further infection and ischemia in DFU can significantly prolong treatment and often result in limb amputation, with more severe cases resulting in terminal illness. Thus, early identification and regular monitoring is necessary to improve care, and reduce the burden on healthcare systems. With that in mind, this study attempts to address the problem of infection and ischemia classification in diabetic food ulcers, in four distinct classes. We have evaluated a series of VGG architectures with different layers, following numerous training strategies, including k-fold cross validation, data pre-processing options, augmentation techniques, and weighted loss calculations. In favor of transparency and reproducibility, we make all the implementations available through the Generally Nuanced Deep Learning Framework (GaNDLF, github.com/CBICA/GaNDLF. Our best model was evaluated during the DFU Challenge 2021, and was ranked 2nd, 5th, and 7th based on the macro-averaged AUC (area under the curve), macro-averaged F1 score, and macro-averaged recall metrics, respectively. Our findings support that current state-of-the-art architectures provide good results for the DFU image classification task, and further experimentation is required to study the effects of pre-processing and augmentation strategies.

Diabetic Foot Ulcer Ischemia and Infection Classification Using EfficientNet Deep Learning Models.

Motivation: Infection (bacteria in the wound) and ischemia (insufficient blood supply) in Diabetic Foot Ulcers (DFUs) increase the risk of limb amputation. Goal: To develop an image-based DFU infection and ischemia detection system that uses deep learning. Methods: The DFU dataset was augmented using geometric and color image operations, after which binary infection and ischemia classification was done using the EfficientNet deep learning model and a comprehensive set of baselines. Results: The EfficientNets model achieved 99% accuracy in ischemia classification and 98% in infection classification, outperforming ResNet and Inception (87% accuracy) and Ensemble CNN, the prior state of the art (Classification accuracy of 90% for ischemia 73% for infection). EfficientNets also classified test images in a fraction (10% to 50%) of the time taken by baseline models. Conclusions: This work demonstrates that EfficientNets is a viable deep learning model for infection and ischemia classification.

Evaluation of the Use of Antibiofilmogram Technology in the Clinical Evolution of Foot Ulcers Infected by Staphylococcus aureus in Persons Living with Diabetes: A Pilot Study.

Infected diabetic foot ulcers (DFUs) represent a serious threat to public health because of their frequency and the severity of their consequences. DFUs are frequently infected by bacteria in biofilms, obstructing antibiotic action. Antibiofilmogram was developed to assess the impact of antibiotics to inhibit biofilm formation. This pilot study aimed to determine the benefits of this technology in predicting antibiotic activity on the outcome of 28 patients with Grade 2 DFUs that were infected by a monomicrobial Staphylococcus aureus. Patients with diabetes were followed during the antibiotic treatment (day 14) and the follow-up period of the study (day 45). The contribution of Antibiofilmogram was compared between patients with non-concordant results (n = 13) between antibiogram and Antibiofilmogram versus concordant results (n = 15). The clinical improvement of wounds (80.0% vs. 38.5%, p = 0.0245) and the absence of exudates (0% vs. 33.3%, p = 0.0282) were observed in concordant vs. discordant groups. This pilot study provides promising results for the interest of Antibiofilmogram in the prescription of antibiotics to prevent biofilm formation in infected DFUs.

Autologous Platelet Rich Plasma Promotes the Healing of Non-Ischemic Diabetic Foot Ulcers. A Randomized Controlled Trial

DFU (diabetic foot ulcer) represents a major global health and socioeconomic problem and a leading cause of lower limb amputation. Although many therapies have been tested, none has been proposed as a dominant wound healing treatment. We performed a prospective randomized controlled study in order to assess the role of autologous platelet rich plasma (PRP) for the promotion of non-ischemic DFU healing. After full vascular assessment, a total of 80 patients were randomized in 1:1 ratio to receive either PRP injection in the healing edge and the floor of the targeted DFU (Group A), or have usual standard care with moist dressing with or without collagenase ointment (Group B). We calculated the total surface area (TSA) for the ulcer in both groups (cm2) before, after treatment and every week up to 12 weeks of follow-up. A total of 4 patients (10%) experienced major amputation in group B, while no major amputation was performed in patients of Group A (P< 0.001). A ≥ 50% reduction in TSA occurred earlier in Group A (at 2.5 weeks), compared to Group B (4.5 weeks); P < 0.001. Complete wound healing rate was 95% (n=38) and it was achieved earlier (6th week) for patients of group A, contrary to 77.8% (n=28) of patients (9th week) for Group B (P < 0.001). Superficial wound infection was noted in 10% (n=4) of the cases in the PRP arm, while in group B, 45% (n=18) of cases had a variable degree of infection ranging from superficial to deep wound infection and cellulites (P < 0.001). PRP treatment was cost-effective, with 247.50$ vs. 437.50$ for the total cost of treatment for patients of Group B. PRP is a cost-beneficial novel modality of treatment that can accelerate wound healing and decrease the rate of local infection in DFU, compared to other conventional treatment modalities.

Microbiota of diabetic foot infections in a University Hospital in Bogotá, Colombia

The presence of infection in diabetic foot ulcers (DFU) is one of the main causes of lower limb amputation in the world. The presence of polymicrobial infections is usually the standard for isolation in such lesions, with Gram Positive (GP) germs being the main organisms involved, as is described in the global literature. However, some studies indicate a greater number of isolates with Gram Negative (GN) germs, reported mainly in the literature of Middle Eastern countries and in the tropics.

Wound Chronicity, Impaired Immunity and Infection in Diabetic Patients.

Diabetic foot ulcers are a common diabetic complication leading to alarming figures of amputation, disability, and early mortality. The diabetic glucooxidative environment impairs the healing response, promoting the onset of a 'wound chronicity phenotype'. In 50% of ulcers, these non-healing wounds act as an open door for developing infections, a process facilitated by diabetic patients' dysimmunity. Infection can elicit biofilm formation that worsens wound prognosis. How this microorganism community is able to take advantage of underlying diabetic conditions and thrive both within the wound and the diabetic host is an expanding research field. 1) Offer an overview of the major cellular and molecular derangements of the diabetic healing process versus physiological cascades in a non-diabetic host. 2) Describe the main immunopathological aspects of diabetics' immune response and explore how these contribute to wound infection susceptibility. 3) Conceptualize infection and biofilim in diabetic foot ulcers and analyze their dynamic interactions with wound bed cells and matrices, and their systemic effects at the organism level. 4) Offer an integrative conceptual framework of wound-dysimmunity-infection-organism damage. We retrieved 683 articles indexed in Medline/PubMed, SciELO, Bioline International and Google Scholar. 280 articles were selected for discussion under four major subheadings: 1) normal healing processes, 2) impaired healing processes in the diabetic population, 3) diabetic dysimmunity and 4) diabetic foot infection and its interaction with the host. The diabetic healing response is heterogeneous, torpid and asynchronous, leading to wound chronicity. The accumulation of senescent cells and a protracted inflammatory profile with a pro-catabolic balance hinder the proliferative response and delay re-epithelialization. Diabetes reduces the immune system's abilities to orchestrate an appropriate antimicrobial response and offers ideal conditions for microbiota establishment and biofilm formation. Biofilm-microbial entrenchment hinders antimicrobial therapy effectiveness, amplifies the host's pre-existing immunodepression, arrests the wound's proliferative phase, increases localized catabolism, prolongs pathogenic inflammation and perpetuates wound chronicity. In such circumstances the infected wound may act as a proinflammatory and pro-oxidant organ superimposed onto the host, which eventually intensifies peripheral insulin resistance and disrupts homeostasis. The number of lower-limb amputations remains high worldwide despite continued research efforts on diabetic foot ulcers. Identifying and manipulating the molecular drivers underlying diabetic wound healing failure, and dysimmunity-driven susceptibility to infection will offer more effective therapeutic tools for the diabetic population.

Treatment of diabetic foot ulcers

Background: Diabetic foot ulcers (DFUs), a risk factor for infection, remain a difficult clinical complication. Infected DFUs may be associated with lower extremity amputation. To achieve wound healing and avoid amputation, an assortment of dressing materials and negative pressure wound therapy (NPWT) have been used on soft tissue injuries resulting from infected DFUs. A great deal of interest about the use of dressing materials and NPWT in the treatment of DFUs has arisen. However, there have only been a few high-quality studies regarding this topic.Current Concepts: Ideal dressing materials should satisfy certain conditions to alleviate symptoms of DFU infection and enhance the wound healing process. A single dressing material cannot fulfill all of these requirements. Based on clinical trials, different dressing materials must be chosen according to the status of the individual wound environment, including the amount of exudate, degree of pain, severity of the infection, and cost-effectiveness. However, there has been no clear evidence that advanced wound dressing materials are superior to basic dressing materials in wound healing. Recently, NPWT has been used to cover the soft tissue defects of infected DFU with granulation tissue. NPWT may contribute to changing growth factor expression, micro- and macro-deformation, vascular flow, amount of exudate, and the bacterial environment in DFU, despite the unclear mechanism of its role in wound repair.Discussion and Conclusion: Further research to obtain high-quality evidence regarding the benefits of using dressing materials and NPWT is needed. The optimal protocol for DFU and cost-effectiveness should be included in these future studies.

Not Only Antimicrobial: Metronidazole Mitigates the Virulence of Proteus mirabilis Isolated from Macerated Diabetic Foot Ulcer

Diabetic foot ulcers are recognized to be a severe complication of diabetes, increasing the risk of amputation and death. The bacterial infection of Diabetic foot ulcers with virulent and resistant bacteria as Proteus mirabilis greatly worsens the wound and may not be treated with conventional therapeutics. Developing new approaches to target bacterial virulence can be helpful to conquer such infections. In the current work, we evaluated the anti-virulence activities of the widely used antibacterial metronidazole. The minimum inhibitory concentrations (MIC) and minimum biofilm eradication concentrations (MEBC) were determined for selected antibiotics which P. mirabilis was resistant to them in the presence and absence of metronidazole in sub-MIC. The effect of metronidazole in sub-MIC on P. mirabilis virulence factors as production of exoenzymes, motilities, adhesion and biofilm formation, were evaluated. Furthermore, molecular docking of metronidazole into P. mirabilis adhesion and essential quorum sensing (QS) proteins, was performed. The results revealed a significant ability of metronidazole to in-vitro inhibit P. mirabilis virulence factors and antagonize its essential proteins. Moreover, metronidazole markedly decreased the MICs and MBECs of tested antibiotics. Conclusively, metronidazole in sub-MIC is a plausible anti-virulence and anti-QS agent that can be combined to other antibiotics as anti-virulence adjuvant to defeat aggressive infections.

Methicillin-Resistant Staphylococcus aureus (MRSA) Infection of Diabetic Foot Ulcers at a Tertiary Care Hospital in Accra, Ghana.

Aim: This study investigated the spectrum of bacteria infecting the ulcers of individuals with diabetes at the Korle Bu Teaching Hospital in Accra, Ghana, focusing on Staphylococcus aureus (S. aureus) and methicillin-resistant S. aureus (MRSA), with respect to their prevalence, factors predisposing to their infection of the ulcers, and antimicrobial resistance patterns. Methodology: This cross-sectional study was conducted at The Ulcer Clinic, Department of Surgery, Korle Bu Teaching Hospital, involving 100 diabetic foot ulcer patients. The ulcer of each study participant was swabbed and cultured bacteriologically, following standard procedures. Antimicrobial susceptibility testing was done for all S. aureus isolated, using the Kirby-Bauer method. Results: In total, 96% of the participants had their ulcers infected—32.3% (n = 31) of these had their ulcers infected with one bacterium, 47.9% (n = 46) with two bacteria, 18.8% (n = 18) with three bacteria, and 1.0% (n = 1) with four bacteria. The prevalence of S. aureus and MRSA were 19% and 6%, respectively. The distribution of the other bacteria was as follows: coagulase-negative Staphylococci (CoNS) (54%), Escherichia coli (24%), Pseudomonas spp. (19%), Citrobacter koseri and Morganella morgana (12% each), Klebsiella oxytoca (11%), Proteus vulgaris (8%), Enterococcus spp. (6%), Klebsiella pneumoniae (5%), Proteus mirabilis and Enterobacter spp. (4%), Klebsiella spp. (2%), and Streptococcus spp. (1%). The resistance rates of S. aureus decreased across penicillin (100%, n = 19), tetracycline (47.4%, n = 9), cotrimoxazole (42.1%, n = 8), cefoxitin (31.6%, n = 6), erythromycin and clindamycin (26.3% each, n = 5), norfloxacin and gentamicin (15.8% each, n = 3), rifampicin (10.5%, n = 2), linezolid (5.3%, n = 1), and fusidic acid (0.0%, n = 0). The proportion of multidrug resistance was 47.4% (n = 9). Except for foot ulcer infection with coagulase-negative Staphylococci, which was protective of S. aureus infection of the ulcers (OR = 0.029, p = 0.001, 95% CI = 0.004–0.231), no predictor of S. aureus, MRSA, or polymicrobial ulcer infection was identified. Conclusions: The prevalence of S. aureus and MRSA infection of the diabetic foot ulcers were high, but lower than those of the predominant infector, coagulase-negative Staphylococci and the next highest infecting agent, E. coli. Diabetic foot ulcers’ infection with coagulase-negative Staphylococci protected against their infection with S. aureus. The prevalence of multidrug resistance was high, highlighting the need to further intensify antimicrobial stewardship programmes.

Medicated multi-targeted alginate-based dressings for potential treatment of mixed bacterial-fungal infections in diabetic foot ulcers

Recently developed medicated dressings target either bacterial or fungal infection only, which is not effective for the treatment of mixed infections common in diabetic foot ulcers (DFUs). This study aimed to develop advanced bioactive alginate-based dressings (films and wafers) to deliver therapeutically relevant doses of ciprofloxacin (CIP) and fluconazole (FLU) to target mixed bacterial and fungal infections in DFUs. The alginate compatibility with the drugs was confirmed by SEM, XRD, FTIR and texture analysis, while the medicated wafers showed better fluid handling properties than the films in the presence of simulated wound fluid. The dressings showed initial fast release of FLU followed by sustained release of CIP which completely eradicated E. coli, S. aureus, P. aeruginosa and reduced fungal load (C. albicans) by 10-fold within 24 h. Moreover, the medicated dressings were biocompatible (>70% cell viability over 72 h) with human primary adult keratinocytes and in-vitro scratch assay showed 65–68% wound closure within 7 days.

An evaluation of ischaemia-modified albumin levels in the development of diabetic foot ulcer.

This study investigated the status of serum ischaemia-modified albumin (IMA) levels in the development of diabetic foot ulcer (DFU) in patients with diabetes mellitus (DM) and in predicting ulcer formation and ulcer grading. Thirty patients with DM, 30 with DFU and 30 healthy controls were included in the study. All participants' demographic characteristics and serum IMA, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and white blood cell (WBC) levels and DFU infection grades were recorded. Nine (30%) patients with DFU were grade 2 according to the grading of International Working Group of the Diabetic Foot, 14 (46.7%) were grade 3 and seven (23.3%) were grade 4. Significant, powerful and positive correlation was determined between serum IMA and albumin-adjusted IMA levels and degrees of DFU (r=0.878 and r=0.846, P<.001 for both). Serum IMA levels in the DFU group were significantly higher than in the DM and control groups (P<.001). The optimal cut-off values for IMA in predicting DFU was 23.5ng/mL (sensitivity 96%, specificity 87% and AUC=0.97, P<.001). Additionally, at a cut-off value of 20.6ng/mL, serum albumin-adjusted IMA differentiated cases of DFU from healthy individuals with 90% sensitivity and 83% specificity (AUC=0.95, P<.001) Serum IMA levels exhibited significant, positive correlation with CRP, ESR, WBC, fasting plasma glucose and HbA1c (r=0.575, r=0.592, r=0.597, r=0.68 and r=0.74, respectively, P<.001). Serum albumin levels were significantly negatively correlated with IMA, CRP, ESR and WBC values (r=-0.49, r=-0.56, r=-0.62 and r=-0.53, respectively, P<.001). Our study findings indicate that together with CRP, ESH, WBC and albumin, increased IMA levels in patients with DM can be useful in the early prevention of DFU development and in predicting the severity of DFU infection.

Effect of Diluted Dakin's Solution Versus Standard Care on Diabetic Foot Ulcer Management: A Randomized Controlled Trial.

Diabetic foot ulcers (DFUs) are the main cause of hospitalizations and amputations in diabetic patients. Failure of standard foot care is the most important cause of impaired DFU healing. Dakin's solution (DS) is a promising broad-spectrum bactericidal antiseptic for management of DFUs. Studies investigating the efficacy of using DS on the healing process of DFUs are scarce. Accordingly, this is the first evidence-based, randomized, controlled trial conducted to evaluate the effect of using diluted DS compared with the standard care in the management of infected DFUs. A randomized controlled trial was conducted to assess the efficacy of DS in the management of infected DFUs. Patients were distributed randomly to the control group (DFUs irrigated with normal saline) or the intervention group (DFUs irrigated with 0.1% DS). Patients were followed for at least 24 weeks for healing, reinfection, or amputations. In vitro antimicrobial testing on DS was performed, including determination of its minimum inhibitory concentration, minimum bactericidal concentration, minimum biofilm inhibitory concentration, minimum biofilm eradication concentration, and suspension test. Replacing normal saline irrigation in DFU standard care with 0.1% DS followed by soaking the ulcer with commercial sodium hypochlorite (0.08%) after patient discharge significantly improved ulcer healing (P < .001) and decreased the number of amputations and hospitalizations (P < .001). The endpoint of death from any cause (risk ratio, 0.13; P = .029) and the amputation rate (risk ratio, 0.27; P < .001) were also significantly reduced. The effect on ulcer closure (OR, 11.9; P < .001) was significantly enhanced in comparison with the control group. Moreover, DS irrigation for inpatients significantly decreased bacterial load (P < .001). The highest values for the in-vitro analysis of DS were as follows: minimum inhibitory concentration (MIC), 1.44%; minimum bactericidal concentration (MBC), 1.44%; minimum biofilm inhibitory concentration (MBIC), 2.16%; and minimum biofilm eradication concentration (MBEC), 2.87%. Compared with standard care, diluted DS (0.1%) was more effective in the management of infected DFUs. Dakin's solution (0.1%) irrigation with debridement followed by standard care is a promising method in the management of infected DFUs.

Microbiological Profile, Antibiogram, and Risk Factors of Patients with Diabetic Foot Infections

Background: Diabetic foot ulcer (DFU) is considered a major social and economic problem, and it is also known as a leading cause of morbidity and mortality. Patients with DFUs frequently require amputation of the lower limbs, and in more than half of the cases, infection is the predominant factor. The aim of this systemic review is to highlight the risk factors such as age and gender associated with DFU infections, whether the infection is caused by single bacteria or polymicrobial infection and what is the most prevalent bacteria and their susceptibility pattern to currently used antibiotics. Methods: Three databases were searched from December 2020 to February 2021 including PubMed, Hinari, and Google Scholar. A total of 12 articles were included in the current meta-analysis. Results: Higher frequency of DFU in males than in females and maximum number of DFU mostly occur within the age group 40–60 years was reported. Monomicrobial infections in DFU were higher than monomicrobial infection. Escherichia coli, Pseudomonas, and Staphylococcus aureus were the most prominent microorganism. The higher grades of the DFUs were infected with more than one organism. High resistance rates of the isolated bacteria to the most commonly used antibiotics were documented and there were alarming growing resistance rate to Carbapenems which were considered the most effective Antibiotics nowadays. Conclusions: DFU infections are one of the major social and economic problems. There is an urgent need for continuous antibiotic sensitivity testing for the isolated bacteria to choose the appropriate antibiotics during the management and limit the spreading of multidrug-resistant bacteria and reduce the burden of health-care cost.

Next-Generation Sequencing for Pathogen Identification in Infected Foot Ulcers.

Background:Accurate identification of primary pathogens in foot infections remains challenging due to the diverse microbiome. Conventional culture may show false-positive or false-negative growth, leading to ineffective postoperative antibiotic treatment. Next-generation sequencing (NGS) has been explored as an alternative to standard culture in orthopedic infections. NGS is highly sensitive and can detect an entire bacterial genome along with genes conferring antibiotic resistance in a given sample. We investigated the potential use of NGS for accurate identification and quantification of microbes in infected diabetic foot ulcer (DFU). We hypothesize that NGS will aid identification of dominant pathogen and provide a more complete profile of microorganisms in infected DFUs compared to the standard culture method.Methods:Data were prospectively collected from 30 infected DFU patients who underwent operative treatment by a fellowship-trained orthopedic foot and ankle surgeon from October 2018 to September 2019. The average age of the patient was 60.4 years. Operative procedures performed were irrigation and debridement (12), toe or ray amputation (13), calcanectomies (4), and below-the-knee amputation (1). Infected bone specimens were obtained intraoperatively and processed for standard culture and NGS. Concordance between the standard culture and NGS was assessed.Results:In 29 of 30 patients, pathogens were identified by both NGS and culture, with a concordance rate of 70%. In standard culture, Staphylococcus aureus (58.6%) was the most common pathogen, followed by coagulase-negative Staphylococcus (24.1%), Corynebacterium striatum (17.2%), and Enterococcus faecalis (17.2%). In NGS, Finegoldia magna (44.8%) was the most common microorganism followed by S. aureus (41.4%), and Anaerococcus vaginalis (24.1%). On average, NGS revealed 5.1 (range, 1-11) pathogens in a given sample, whereas culture revealed 2.6 (range, 1-6) pathogens.Conclusion:NGS is an emerging molecular diagnostic method of microbial identification in orthopedic infection. It frequently provides different profiles of microorganisms along with antibiotic-resistant gene information compared to conventional culture in polymicrobial foot infection. Clinical use of NGS for management of foot and ankle infections warrants further investigation.Level of Evidence:Level II, diagnostic study.

Osteomyelitis, diabetic foot ulcers and the role of the community nurse.

Community nurses face numerous challenges in both diagnosing and effectively treating their patients. The diabetic patient has complex needs requiring a holistic approach. With a reported increase in diabetic patients, and a possible decline in some routine screening following Covid-19 pandemic, complications in diabetic patients are likely to rise. It is estimated that 25% of diabetic patients will develop a diabetic foot ulcer (DFU), with a reported 43% of DFU already infected at first presentation to a health professional. NICE categorise the level of infection in DFU based on standardised assessments such as SINBAD. A high categorised DFU has the possibility of osteomyelitis. It is imperative that osteomyelitis is treated immediately to achieve positive outcomes, benefitting the patients' health and wellbeing in addition to reducing the financial implications to the NHS.

PDB15 Cost-Effectiveness of a NOVEL Treatment for Diabetic Foot Ulcer Among Patients with Diabetes: A Modeling Study

We evaluated the cost-effectiveness of a novel treatment - ON101 cream, which was recently introduced for treating diabetic foot ulcer (DFU) as add-on to standard care (SC), versus SC among diabetic patients from the healthcare sector perspective. A Markov model with six health states (i.e., uninfected DFU, infected DFU, healed DFU, history of amputation, gangrene, and all-cause death) was adopted to assess the cost-effectiveness of ON101 versus SC for treating DFU, with one-month cycle length for a 5-year simulation in the base-case analysis. Data from the ON101 phase 3 trial involving 236 DFU cases for a 16-week follow-up were used to generate efficacy parameters (transition probabilities between health states) for the model. Costs and health utilities associated with health states were drawn from published literature and estimated using Taiwan’s National Health Insurance Research Database. Costs were expressed in 2020 U.S. dollars. Future costs and effectiveness were discounted at 3% annually. One-way and probabilistic sensitivity analyses were performed to examine the robustness of study results. Attributed by a higher healing rate and shorter healing time of using ON101, the base-case analysis showed that ON101 treatment was associated with lower costs and higher quality-adjusted life years (QALYs) over 5 years. The total healthcare cost per ON101-treated patient was lower than that of a patient with SC (i.e., $14,270 versus $22,135), while QALYs per ON101-treated patient were higher than those of a patient with SC (i.e., 3.565 versus 3.545 QALYs). Results were robust across the sensitivity analyses. The novel treatment, ON101, versus SC would be cost-saving for DFU owing to its better efficacy.

Recognition of ischaemia and infection in diabetic foot ulcer: A deep convolutional neural network based approach

AbstractDiabetic foot ulcers (DFUs) result in amputation of lower limbs or feet without timely assessment and treatment. The assessment of DFUs is performed by the diagnosis of DFU ischaemia and infection. In this work, a new deep convolutional neural network (CNN) based approach (ResKNet) is proposed to perform such assessment. The proposed network consists of a series of unique residual blocks of 2D convolution, batch normalization, and LeakyReLU with skip connections. It has been experimentally observed that a shallower network with 4 such unique residual blocks (Res4Net) can achieve promising results in ischaemia recognition, with an impressive AUC value of 0.9968. However in case of infection recognition, a network with 7 such residual blocks (Res7Net) achieved the best performance, with an AUC value of 0.8890. Such improvements to the current state‐of‐the‐art results suggests that the proposed approach can provide significant help to medical experts, for automatic assessment of DFU.

Postoperative healing in the diabetic foot is impacted by discharge destination.

The aim of this study was to evaluate the impact of discharge destination on diabetes‐related limb salvage surgery outcomes post‐hospitalisation. This was a single‐centre, observational, descriptive study of 175 subjects with diabetes who underwent limb salvage surgery of a minor foot amputation or wide incision and debridement for an acutely infected diabetic foot ulcer (DFU). Comparisons were made between subjects discharged home vs a skilled nursing facility (SNF) for 12 months postoperatively. Univariate, multivariate, and time‐to‐event analyses were performed. The SNF discharge group (n = 40) had worse outcomes with longer healing time (P = .022), more rehospitalisations requiring a podiatry consult (P = .009), increase of subsequent ipsilateral major lower‐extremity amputation (P = .028), and a higher mortality rate (P = .012) within the 12‐month postoperative period. There was no significant difference between the cohorts in surgically cleared osteomyelitis (P = .8434). The Charlson Comorbidity Index values for those discharged home and those in a short‐term nursing facility were similar (P = .3819; home x¯=5.33 ± 2.84 vs SNF x¯=5.75 ± 2.06). The planned discharge destination after limb salvage surgery among people with an acutely infected DFU should be an added risk factor for healing outcomes. Patients discharged to SNFs experience additional morbidity and mortality compared with patients discharged home post‐hospitalisation.