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Diabetic foot infection imposes a significant burden and is the major cause of nontraumatic limb amputation. Adequate patient management with effective antibiotic therapy is crucial.This retrospective cohort study aimed to characterize the microbiology and resistance patterns of moderate to severe neuropathic diabetic foot infection in patients hospitalized at a tertiary referral hospital between January 2020 and June 2023. Deep tissue specimens from ulcers were collected for culture.Sixty inpatients were included (62% male, mean age 59.1 ± 11.5 years). Osteomyelitis was present in 90% of the patients. Among 102 microorganisms (average of 1.91 ± 1.25 pathogens per patient), 60.8% were gram-positive bacteria, 31.4% were gram-negative, 3.92% were anaerobic bacteria, and 3.92% were fungi. Staphylococcus aureus (19%) and Enterococcus faecium (17%) were the most common. Pseudomonas aeruginosa (8%) and bacteria of the Enterobacterales family (24%) accounted for all the isolated gram-negative bacteria. Sixteen percent of Staphylococcus aureus and 67% of coagulase-negative Staphylococci were resistant to methicillin. Resistance to ampicillin was found in 11% of Enterococci. All Pseudomonas aeruginosa isolates were sensitive to piperacillin-tazobactam, ceftazidime, or cefepime. Among the Enterobacterales, resistance rates were 35% for piperacillin-tazobactam, 38% for ceftazidime, 21% for cefepime, and 13% for carbapenems.Although the prevalence of methicillin-resistant staphylococci was lower than that in other studies, carbapenem resistance among gram-negative bacteria warrants attention. This study highlights the importance of understanding local epidemiology for effective diabetic foot infection management and resistance mitigation.
Subject(s)
Anti-Bacterial Agents , Diabetic Foot , Tertiary Care Centers , Humans , Diabetic Foot/microbiology , Diabetic Foot/drug therapy , Male , Middle Aged , Retrospective Studies , Tertiary Care Centers/statistics & numerical data , Female , Aged , Anti-Bacterial Agents/therapeutic use , Anti-Bacterial Agents/pharmacology , Portugal/epidemiology , Microbial Sensitivity Tests , Osteomyelitis/microbiology , Osteomyelitis/drug therapy , Gram-Negative Bacteria/drug effects , Gram-Negative Bacteria/isolation & purification , Gram-Negative Bacteria/classification , Bacteria/isolation & purification , Bacteria/classification , Bacteria/drug effects , Bacteria/genetics , Gram-Positive Bacteria/drug effects , Gram-Positive Bacteria/isolation & purification , Gram-Positive Bacteria/classificationABSTRACT
Objective of the study was to find the association of vitamin D receptor (VDR) polymorphisms (Fokl, Taql and Apal) with vitamin D levels in diabetic foot ulcer (DFU) patients in South India. In this case-control study, plasma vitamin D levels and VDR genotype frequencies of 70 cases (DFU patients) were compared with 70 diabetic (diabetes mellitus [DM] [non-DFU]) patients and 70 apparently healthy controls (HC) from South India. Plasma vitamin D levels were measured using the ELISA technique, and genotyping of VDR polymorphisms was carried out using real-time polymerase chain reaction. Logistic regression was used to find the association between DFU versus HC and DFU versus DM traits. Association analysis was performed based on additive, dominant and recessive models with age and gender as covariates. A 45.7% of DFU patients have sufficient vitamin D levels than 48.6% and 40% of DM patients and HC, respectively. Linkage disequilibrium analysis for DFU versus HC and DFU versus DM traits shows that single nucleotide polymorphisms (SNPs) Taq1 (rs731236) and Apal (rs7975232) are in strong linkage disequilibrium in DFU patients. The alleles and genotype frequencies were similar in all three groups. Although the additive model does not show statistical significance, age and sex correlate with the three SNPs (Fokl, Taql and Apal). No association was found between VDR gene polymorphisms and vitamin D levels in DFU patients in Southern India. On the other hand, age and sex correlate with the three SNPs.
Subject(s)
Diabetic Foot , Polymorphism, Single Nucleotide , Receptors, Calcitriol , Vitamin D , Humans , Diabetic Foot/genetics , Diabetic Foot/blood , Receptors, Calcitriol/genetics , Male , Female , India , Middle Aged , Prospective Studies , Vitamin D/blood , Case-Control Studies , Polymorphism, Single Nucleotide/genetics , Aged , Adult , Tertiary Healthcare , Vitamin D Deficiency/genetics , Vitamin D Deficiency/blood , Vitamin D Deficiency/complications , Genotype , Genetic Predisposition to DiseaseABSTRACT
Enhanced recovery after surgery (ERAS) has been successfully integrated into a diverse array of surgical fields to improve the quality and efficacy of treatment intervention. Nonetheless, the application of the ERAS protocol for patients with diabetic foot ulcer (DFU) subsequent to undergoing surgical procedures has not been previously explored. Therefore, this study aimed to investigate the effect of an enhanced recovery protocol on perioperative outcomes in patients with DFU following surgical procedures. A retrospective analysis was conducted on 112 patients with DFU who underwent surgery between January 2020 and December 2021 at a tertiary referral care center. In total, 57 patients received standard perioperative care (the non-ERAS group), and 55 patients received ERAS care (the ERAS group). The primary outcomes included the length of stay (LOS), wound healing time, patient satisfaction, and costs, serving as the basis for assessing the effectiveness of the two approaches. Secondary outcomes included preoperative anxiety (APAIS score), nutritional status (PG-SGA), pain (NRS score), the incidence of lower-extremity deep vein thrombosis (DVT), the reduction in lower-limb circumference, and the activity of daily living scale (Barthel Index). The ERAS group exhibited significantly shorter LOS (11.36 vs. 26.74 days; P < 0.001) and lower hospital costs (CNY 62,165.27 vs. CNY 118,326.84; P < 0.001), as well as a higher patient satisfaction score and Barthel Index score (P < 0.05). Additionally, we found a lower APAIS score, incidence of DVT, and circumference reduction in lower limbs in the ERAS group compared to the non-ERAS group (P < 0.05). In comparison, the wound healing time, nutritional status, and pain levels of participants in both groups showed no significant difference (P > 0.05). By reducing the LOS and hospital costs, and by minimizing perioperative complications, the ERAS protocol improves the quality and efficacy of treatment intervention in patients with DFU who underwent surgical procedures.Trial registration number: ChiCTR 2200064223 (Registration Date: 30/09/2022).
Subject(s)
Diabetic Foot , Enhanced Recovery After Surgery , Length of Stay , Humans , Male , Female , Retrospective Studies , Diabetic Foot/surgery , Middle Aged , Aged , Wound Healing , Patient Satisfaction , Perioperative Care/methods , Treatment OutcomeABSTRACT
Objectives: This study was aimed to determine the various factors which could serve as predictor of saving of lower limb from amputation in patients with diabetic foot ulcer (DFU). Method: This three-year retrospective study was conducted in the Diabetes and Endocrinology Unit of Hayatabad Medical complex Peshawar, Pakistan. Demographic, clinical, laboratory and radiological information of the diabetic patients with DFU admitted between January 2020 to December 2022 was retrieved from the hospital files. Information regarding initial and final decision regarding amputation and the outcome of the ulcer was also recorded. Results: A total of 502 patients of diabetes mellitus (DM) with DFU were included in the study, of whom there were 279 (55.6%) males and 223 (44.4%) females. The mean age of the study population, mean duration of DM and mean HbA1c were 55.2 ± 9.8 years, 13.7 ± 6.7 years and 11.2 ± 2.4 %, respectively. Patients who had an amputation of their lower limbs had an increased age (p= 0.034), raised total leucocyte count (TLC) (p= <0.001), higher HbA1c (p= 0.025), had osteomyelitis (p= <0.001), and had a higher-grade ulcer (p= <0.001). On binary logistic regression analysis, ulcer grade (OR=7.4, p= <0.001), osteomyelitis (OR=11.8, p= <0.001), and initial decision of no amputation at the time of admission (OR=33.6, p=<0.001) were independently associated with the lower limb salvage. Conclusion: DFU which were of grade I to II, had no evidence of osteomyelitis and for which an initial decision was of no amputation were more likely to be salvaged.
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The relationship between the depth of the diabetes-related foot ulcers, and the healing days, cost, and QOL was examined.Depth 4 and 5 ulcers, namely beyond the tendons, exhibited significantly longer healing days and higher costs than Depth 2 and 3 ulcers. As for QOL, there were no significant differences in utility values between the depth categories.Results on healing time and cost reiterate the importance of early consultation, especially before the depth becomes deeper than the tendon.
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Foot ulcerations are one of the most common complications of diabetes and one of the major initial causes of amputations. The formation of biofilms on wounds significantly contributes to infections and delayed healing. While existing methods for identifying these biofilms have limitations, there is a need for a convenient tool for its clinical application. This literature review aimed to address the problem with current clinical biofilm identification in wound care and a proposal for biofilm-detection-based wound care in diabetic foot ulcer patients. Identifying biofilms is particularly vital due to the absence of typical signs of infection in DFUs. However, current approaches, although effective, often prove invasive and technically intricate. The wound blotting technique, involving attaching a nitrocellulose membrane and subsequent staining, presents an alternative that is swift and non-invasive. Research highlights the applicability of wound blotting with alcian blue staining in clinical scenarios, consistently producing sensitive outcomes. By addressing the critical need for early biofilm detection, wound blotting holds promise for enhancing DFU management and contributing to strategies aimed at preventing amputations.
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Introduction: Diabetes is associated with several debilitating complications, including the development of diabetic foot ulcers (DFUs), which can have serious consequences. This study emphasizes a multidisciplinary approach, providing a thorough overview of DFU pathogenesis and available treatments. Methods: An extensive literature review, covering studies published between 2000 and 2023, was conducted to gather data on DFU pathophysiology and treatments, including wound dressings, photobiomodulation, off-loading devices, adjunct medicines, and stem cell therapy. Results: DFUs are complicated due to infection, ischemia, and neuropathy. Sufficient wound dressings maintain a moist environment, promoting autolytic debridement and facilitating the healing process. Through cellular mechanisms, photobiomodulation therapy (PBM) was observed to expedite the healing process. Additionally, off-loading devices were invented to reduce ulcer pressure and promote healing. Adjunct therapies such as negative pressure wound therapy and hyperbaric oxygen therapy were identified as valuable tools for enhancing healing outcomes. Furthermore, autologous and allogeneic stem cell treatments exhibited the potential for promoting tissue regeneration and expediting the healing process. Conclusion: The complex pathophysiology of DFUs necessitates a multimodal treatment approach. Essential components include PBM, wound dressings, off-loading devices, adjunct treatments, and stem cell therapy.
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BACKGROUND: Diabetes related foot ulcer (DFU) is a leading cause of impaired quality of life, disability, hospitalisation, amputation and mortality in people with diabetes. It is therefore critical that podiatrists across all settings, including community settings, are confident and capable of providing care for diabetes-related foot complications. This study aims to describe current practice, confidence and anxiety levels of community podiatrists in the management of patients with foot ulceration. Furthermore, current barriers to service provision and interest in future educational opportunities will also be explored. METHODS: An online cross-sectional survey was distributed to Australian community podiatrists. Descriptive variables including gender, age, professional experience, practice location and practise setting were elicited. A modified competitive State Anxiety Inventory-2 (CSAI-2) was utilised to measure anxiety related to managing a foot ulcer. Other questions included a combination of multiple choice and open-ended free-text responses relating to assessment, confidence and referral pathways. RESULTS: One hundred and twenty-two Australian community-based podiatrists responded to the survey. A variety of ulcer sizes and complexity were reported to be managed in community settings. Confidence in DFU management was high in most manual skill domains including: stabilisation of the foot (85.7%, standard deviation [SD] 17.42), scalpel control (83.0%, SD 20.02), debridement with a scalpel (82.7%, SD 18.19) and aseptic technique (81.0%, SD 18.62, maintaining integrity of healthy tissue (77.3%, SD 21.11), removal of appropriate tissue (75.6%, SD 22.53), depth of ulceration (73.7%, SD 23.99) and ability to manage messy wounds (69.1%, SD 26.04). Curette debridement had substantially lower levels of reported confidence (41.0%, SD 34.24). Performance anxiety was low with somatic and cognitive anxiety of 6/24 and 3/8 on the CSAI-2, respectively. CONCLUSION: Community podiatrists are managing foot ulcers of varying size and complexity. Confidence and anxiety do not pose a barrier to care. Adherence to wound assessment clinical guidelines is low and confidence with the use of curette was sub-optimal. Further educational programs may overcome these barriers and support shared models of care between community and acute podiatry services.
Subject(s)
Anxiety , Diabetic Foot , Podiatry , Humans , Cross-Sectional Studies , Male , Female , Australia , Diabetic Foot/therapy , Diabetic Foot/psychology , Middle Aged , Anxiety/etiology , Anxiety/therapy , Adult , Clinical Competence/statistics & numerical data , Aged , Attitude of Health Personnel , Surveys and QuestionnairesABSTRACT
Background: Foot infections, a frequent complication of diabetes mellitus, are associated with heavy resource utilization, including antibiotic therapy and surgeries. However, the most common type of isolated pathogen in diabetic foot infections remains unknown. We aimed to identify the most common types of isolated pathogens in diabetic foot infections. Methods: This retrospective cohort study was conducted in a specialized medical center in Jeddah, Saudi Arabia. A total of 96 patients diagnosed with diabetes and presented with a foot ulcer showing clinical signs of infection were included. Results: The mean age was 63.03 ± 10.88 years, and 67.7% were males. The mean duration of diabetes diagnosis was 21.86 ± 9.66 years, and the majority had foot ulcers for over six weeks. Bacteria were present in 65 patients (67.7%), Gram-negative organisms were observed in 37 patients (38.5%), and Gram-positive organisms were present in 28 patients (29.2%). In the 65 patients with bacterial culture, Staphylococcus aureus was the most common isolated organism and was observed in 18 patients (27.7%), followed by Escherichia coli in 11 (16.9%) and Pseudomonas aeruginosa in 10 (15.4%). Binary regression analyses found that Gram-negative organisms were significantly more multidrug-resistant than Gram-positive organisms (P = 0.012, OR = 7.172, 95% CI = 1.542-33.352). Patient outcomes included healed ulcers (n = 10, 10.4%), minor amputation (n = 16, 16.7%), major amputation (n = 1, 1%), and debridement (n = 48, 50%). Conclusion: Gram-negative organisms were predominant in patients with diabetes and foot ulcers having clinical signs of infection. Treatment with an individualized antibiotic regimen is vital in ensuring optimal outcomes and preventing major amputations.
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BACKGROUND: Physical activity (PA), sleep and sedentary time are now recognised as mutually exclusive and exhaustive parts of the 24-h day-if PA decreases, time spent sleeping, being sedentary or both must increase so that all components equate to 24 h. Recent advances in time-use epidemiology suggest that we should not consider time-use domains (PA, sleep and sedentary time) in isolation from each other, but in terms of a composition-the mix of time-use domains across the 24-h day. While interrelated daily activities are known to be important in the management of diabetes mellitus, few studies have investigated the interrelated daily activities in people with an active diabetes-related foot ulcer (DFU) and their impact on important outcomes such as wound severity, blood glucose control and health-related quality of life (HRQoL). This feasibility study aims to determine the acceptability and practicality of measuring 24-h use of time data in people with a DFU and its associations on important outcome measures for this population. METHODS: Participants wore a wrist-worn accelerometer for two weeks and completed demographic and HRQoL questionnaires. Outcomes were participant engagement, reported levels of study burden and value and compositional data analysis as a methodological approach for evaluating 24-h use of time data. RESULTS: Twenty-six participants reported low levels of study burden and rated the study value highly. The protocol appears feasible in terms of recruitment (81%) and retention rate (86%). On average, participants were relatively sedentary spending 747, 172 and 18 min in sedentary time, light physical activity and moderate-to-vigorous activity, respectively. Sleep appeared adequate with participants obtaining an average of 485 min, but quality of sleep was notably poor with average sleep efficiency of 75%. Compositional data analysis was able to quantify the integrated associations of 24-h use of time with HRQoL. CONCLUSION: The protocol provides an acceptable method to collect 24-h use of time data in people with a DFU. Efforts to consider and analyse PA as part of a 24-h activity composition may provide holistic and realistic understandings of PA in this clinical population.
Subject(s)
Diabetic Foot , Exercise , Feasibility Studies , Quality of Life , Sedentary Behavior , Sleep , Humans , Diabetic Foot/physiopathology , Female , Male , Middle Aged , Exercise/physiology , Sleep/physiology , Aged , Time Factors , Accelerometry/methods , Surveys and Questionnaires , Activities of Daily Living , AdultABSTRACT
Leprosy is a chronic infectious disease that has a slow evolution and is characterized by dermatoneurological involvement. The health challenges surrounding this disease are closely related to the stigma that results from the physical disabilities it causes. This is due to its high rate of late diagnosis and the peculiar deformities that occur in its advanced stage. Evaluate the clinical and epidemiological aspects of patients with plantar lesions who were treated for leprosy in a dermatology referral unit. This is a cross-sectional exploratory field study that was conducted at the Reference Center in Tropical Dermatology and Venereology Alfredo da Matta (FUHAM), in Manaus, Amazonas, Brazil. We evaluated 36 patients with disabilities as a result of leprosy and who had plantar lesions. The most common ulcer site was the medial region of the plantar surface, which presented dryness and maceration with yellowish seropurulent exudate, fibrinous tissue and grade 2 depth. The study made it possible to observe the evolution of plantar ulcers resulting from the disease process, then evaluate them and discuss recommendations regarding the treatment and prevention of this type of physical disability.
Subject(s)
Leprosy , Humans , Leprosy/epidemiology , Leprosy/diagnosis , Leprosy/complications , Cross-Sectional Studies , Male , Female , Adult , Brazil/epidemiology , Middle Aged , Foot Ulcer/diagnosis , Foot Ulcer/epidemiology , Foot Ulcer/etiology , Foot Ulcer/therapy , Young Adult , Disabled Persons/statistics & numerical data , Aged , AdolescentABSTRACT
Diabetes prevalence continues to increase worldwide, which has led to a rising incidence of diabetes-related foot infections (DFIs). There is significant local variation in the microbiology of DFIs, and Pseudomonas spp. is suggested to be more prevalent in subtropical climates. The aim of this study was to investigate the local microbiological findings in patients admitted to the hospital with DFIs. This retrospective study analysed data from all adult patients diagnosed with diabetes and admitted to the hospital for the treatment of a DFI between 1 January 2021 and 31 December 2022. Both superficial wound swabs and tissue cultures were included. The Infectious Diseases Society of America classification system was used to categorise the severity of the DFI. Patient characteristics and demographics were analysed using descriptive statistics. One hundred fifty-one episodes of care were included. Most of the DFIs were classified as moderate infections 101/151 (67%). The most commonly isolated microorganism was Staphylococcus aureus (33%) followed by normal skin flora (11%) and ß-haemolytic streptococci (7%). P. aeruginosa was isolated more commonly in those with chronic DFIs (10%) compared to those with acute DFIs (2%). Despite the frequent identification of S. aureus, 83% of patients received an antipseudomonal antibiotic. The introduction of multidisciplinary DFI rounds should be considered.
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OBJECTIVE: Diabetic foot ulcers (DFU) are a major sequela of uncontrolled diabetes with a high risk of adverse outcomes. Poor DFU outcomes disproportionately impact patients living in rural and economically distressed communities with lack of access to consistent, quality care. This study aimed to analyze the risk of geographic and economic disparities, including rural status and county economic distress, on the disease burden of DFU at presentation utilizing the SVS WIfI classification system. METHODS: We conducted a retrospective review of 454 patients diagnosed with a DFU from 2011 to 2020 at a single institution's inpatient and outpatient wound care service. Patients >18 years old, with type II diabetes mellitus, and diabetic foot ulcer were included. RESULTS: ANCOVA analyses showed rural patients had significantly higher WIfI composite scores (F(1,451) = 9.61, p = .002), grades of wound (F(1,439) = 11.03, p = .001), and ischemia (F(1,380) = 12.574, p = .001) compared to the urban patients. Patients that resided in at-risk economic counties had significantly higher overall WIfI composite scores (F(2,448) = 3.31, p = .037) than patients who lived in transitional economic counties, and higher foot infection grading (F(2,440) = 3.02, p = .05) compared to patients who lived in distressed economic counties. DFU patients who resided in distressed economic counties presented with higher individual grades of ischemia (F(2, 377) = 3.14, p = .04) than patients in transitional economic counties. Chi-Square analyses demonstrated patients who resided in urban counties were significantly more likely to present with grade 1 wounds (χ2(3) = 9.86, p = .02) and grade 0 ischemia (χ2(3) = 16.18, p = .001) compared to patients in rural areas. Economically distressed patients presented with significantly less grade 0 ischemia compared to patients in transitional economic counties (χ2(6) = 17.48, p = .008). CONCLUSIONS: Our findings are the first to demonstrate the impact of geographic and economic disparities on the disease burden of DFU at presentation utilizing the SVS WIfI classification system. This may indicate need for improved multidisciplinary primary care prevention strategies with vascular specialists in these communities to mitigate worsening DFU and promote early intervention.
Subject(s)
Diabetic Foot , Rural Population , Humans , Diabetic Foot/economics , Diabetic Foot/epidemiology , Diabetic Foot/classification , Male , Female , Middle Aged , Retrospective Studies , Aged , Rural Population/statistics & numerical data , Ischemia/economics , Ischemia/epidemiology , Ischemia/complications , Ischemia/classification , Risk Assessment , Financial Stress/epidemiology , Financial Stress/economics , Lower Extremity , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/economics , Diabetes Mellitus, Type 2/epidemiology , Severity of Illness Index , Cost of IllnessABSTRACT
Diabetic foot ulcers (DFU) are a debilitating and life-threatening complication of Diabetes Mellitus. Ulceration develops from a combination of associated diabetic complications, including neuropathy, circulatory dysfunction, and repetitive trauma, and they affect approximately 19-34% of patients as a result. The severity and chronic nature of diabetic foot ulcers stems from the disruption to normal wound healing, as a result of the molecular mechanisms which underly diabetic pathophysiology. The current standard-of-care is clinically insufficient to promote healing for many DFU patients, resulting in a high frequency of recurrence and limb amputations. Biomaterial dressings, and in particular those derived from the extracellular matrix (ECM), have emerged as a promising approach for the treatment of DFU. By providing a template for cell infiltration and skin regeneration, ECM-derived biomaterials offer great hope as a treatment for DFU. A range of approaches exist for the development of ECM-derived biomaterials, including the use of purified ECM components, decellularisation and processing of donor/ animal tissues, or the use of in vitro-deposited ECM. This review discusses the development and assessment of ECM-derived biomaterials for the treatment of chronic wounds, as well as the mechanisms of action through which ECM-derived biomaterials stimulate wound healing.
Subject(s)
Biocompatible Materials , Diabetic Foot , Extracellular Matrix , Wound Healing , Wound Healing/drug effects , Humans , Extracellular Matrix/metabolism , Animals , Diabetic Foot/therapyABSTRACT
Background: The number of prediction models for diabetic foot ulcer (DFU) risk is increasing, but their methodological quality and clinical applicability are uncertain. We conducted a systematic review to assess their performance. Methods: We searched PubMed, Cochrane Library, and Embase databases up to 10 February 2024 and extracted relevant information from selected prediction models. The Prediction model Risk Of Bias ASsessment Tool (PROBAST) checklist was used to assess bias risk and applicability. All statistical analyses were conducted in Stata 14.0. Results: Initially, 13,562 studies were retrieved, leading to the inclusion of five development and five validation models from eight studies. DFU incidence ranged from 6% to 16.8%, with age and hemoglobin A1C (HbA1c) commonly used as predictive factors. All included studies had a high risk of bias, mainly due to disparities in population characteristics and methodology. In the meta-analysis, we observed area under the curve (AUC) values of 0.78 (95% CI [0.69-0.89]) for development models and 0.84 (95% CI [0.79-0.90]) for validation models. Conclusion: DFU risk prediction models show good overall accuracy, but there is a risk of bias. Adherence to the PROBAST checklist is crucial for improving their clinical applicability.
Subject(s)
Diabetic Foot , Diabetic Foot/epidemiology , Diabetic Foot/diagnosis , Humans , Risk Assessment/methods , Risk Factors , Glycated Hemoglobin/analysis , Models, StatisticalABSTRACT
INTRODUCTION: Therapeutic offloading devices, including insoles, shoes, and other orthoses, are some of the most commonly used interventions to treat or prevent diabetic foot ulceration. Custom-made offloading devices are increasingly used to offset the development of foot ulcers. However, whether these devices are more effective than prefabricated standard offloading devices is uncertain. Therefore, this systematic review collates and examines evidence on the efficacy of custom-made offloading devices in preventing foot ulcer incidence and recurrence in people diagnosed with diabetes. METHODS: Five scientific databases were searched, covering 2011-2023. Initial searches and screening were carried out independently by two researchers. Studies meeting the inclusion criteria were further examined through additional screenings, and critical appraisal. Data relevant to the review aims were extracted and analysed within a narrative synthesis. RESULTS: Of the 1,715 articles found in the initial searches, nine papers were found to meet inclusion criteria and were included in the review. The evidence shows that custom-made offloading devices are likely to be more effective for reducing or preventing diabetic foot ulcers than standard offloading devices. However, due to a lack of data it remains uncertain whether custom-made offloading devices are more cost-effective for preventing ulceration compared to standard insoles. Likewise, due to measurement heterogeneity between studies and lack of data, it is unclear whether adherence is higher in users of custom-made offloading devices, and whether such devices deliver significantly greater reductions in peak pressure as compared to standard offloading devices. CONCLUSION: Custom-made offloading devices are more effective than standard devices for preventing diabetic foot ulceration, and we recommended their use when feasible; however, there remains uncertainty regarding their cost-effectiveness compared to standard insoles and offloading devices.
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BACKGROUND: Diabetic foot ulcer is one of the most prevalent, serious, and costly consequences of diabetes, often associated with peripheral neuropathy and peripheral arterial disease. These ulcers contribute to high disability and mortality rates in patients and pose a major challenge to clinical management. OBJECTIVE: To systematically review the risk prediction models for post-healing recurrence in diabetic foot ulcer (DFU) patients, so as to provide a reference for clinical staff to choose appropriate prediction models. METHODS: The authors searched five databases (Cochrane Library, PubMed, Web of Science, EMBASE, and Chinese Biomedical Database) from their inception to September 23, 2023, for relevant literature. After data extraction, the quality of the literature was evaluated using the Predictive Model Research Bias Risk and Suitability Assessment tool (PROBAST). Meta-analysis was performed using STATA 17.0 software. RESULTS: A total of 9 studies involving 5956 patients were included. The recurrence rate after DFU healing ranged from 6.2 % to 41.4 %. Nine studies established 15 risk prediction models, and the area under the curve (AUC) ranged from 0.660 to 0.940, of which 12 models had an AUC≥0.7, indicating good prediction performance. The combined AUC value of the 9 validation models was 0.83 (95 % confidence interval: 0.79-0.88). Hosmer-Lemeshow test was performed for 10 models, external validation for 5 models, and internal validation for 6 models. Meta-analysis showed that 14 predictors, such as age and living alone, could predict post-healing recurrence in DFU patients (p < 0.05). CONCLUSION: To enhance the quality of these risk prediction models, there is potential for future improvements in terms of follow-up duration, model calibration, and validation processes.