Assessing the influence of rural residence and economic distress on lower extremity risk stratification among diabetic foot ulcer patients utilizing the Wound, Ischemia, and Foot Infection (WIfI) classification system.

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.

Cost-effectiveness of temperature monitoring to help prevent foot ulcer recurrence in people with diabetes: A multicenter randomized controlled trial.

AIMS: Diabetes-related foot ulcers are common, costly, and frequently recur. Multiple interventions help prevent these ulcers. However, none of these have been prospectively investigated for cost-effectiveness. Our aim was to evaluate the cost-effectiveness of at-home skin temperature monitoring to help prevent diabetes-related foot ulcer recurrence. MATERIALS AND METHODS: Multicenter randomized controlled trial. We randomized 304 persons at high diabetes-related foot ulcer risk to either usual foot care plus daily at-home foot skin temperature monitoring (intervention) or usual care alone (control). Primary outcome was cost-effectiveness based on foot care costs and quality-adjusted life years (QALY) during 18 months follow-up. Foot care costs included costs for ulcer prevention (e.g., footwear, podiatry) and for ulcer treatment when required (e.g., consultation, hospitalisation, amputation). Incremental cost-effectiveness ratios were calculated for intervention versus usual care using probabilistic sensitivity analysis for willingness-to-pay/accept levels up to €100,000. RESULTS: The intervention had a 45% probability of being cost-effective at a willingness-to-accept of €50,000 per QALY lost. This resulted from (non-significantly) lower foot care costs in the intervention group (€6067 vs. €7376; p = 0.45) because of (significantly) fewer participants with ulcer recurrence(s) in 18 months (36% vs. 47%; p = 0.045); however, QALYs were (non-significantly) lower in the intervention group (1.09 vs. 1.12; p = 0.35), especially in those without foot ulcer recurrence (1.09 vs. 1.17; p = 0.10). CONCLUSIONS: At-home skin temperature monitoring for diabetes-related foot ulcer prevention compared with usual care is at best equally cost-effective. The intervention resulted in cost-savings due to preventing foot ulcer recurrence and related costs, but this came at the expense of QALY loss, potentially from self-monitoring burdens.

Randomized Double-blind Cost-effectiveness Comparison of Two 10% Urea Creams in Patients with Diabetic Foot Syndrome.

OBJECTIVE: To evaluate the cost-effectiveness of two 10% urea creams in patients with diabetic foot syndrome. METHODS: This was a prospective, longitudinal, single-center, randomized, double-blind, prospective clinical trial that evaluated the skin quality of 20 feet belonging to 10 patients with diabetic foot syndrome after the application of two 10% urea creams purchased from pharmacies and supermarkets. RESULTS: At follow-up, 19 (95%) of the participants' feet showed improved skin quality, irrespective of the cream applied. On visual inspection, participants had a decreased presence of xerosis, hyperkeratosis, and preulcerative signs such as subkeratotic bruising and areas of redness on the dorsum of the toes. At the 3-month follow-up, nine (90%) of the participants stated that they had continued to apply the cream as a method of self-management to prevent complications. CONCLUSIONS: Creams containing 10% urea purchased in supermarkets improve foot skin quality in patients with diabetic foot syndrome, regardless of their cost. Based on these findings, the authors recommend creams containing 10% urea as a self-management tool for patients with diabetic foot syndrome.

Costos directos en el tratamiento del pie diabético Unidad de Pie Diabético. Hospital de Clínicas. Universidad de la República / Direct costs of diabetic foot treatment Diabetic Foot Department Clínicas Hospital UDELAR / Custos diretos no tratamento do Pé Diabético Unidad de Pie Diabético. Hospital de Clínicas. UDELAR

En el mundo un paciente diabético gasta entre dos y tres veces más que el no diabético. El pie diabético disminuye la calidad de vida, aumenta la morbimortalidad y la carga económica del sistema de salud. Objetivo: comunicar la investigación realizada sobre costos directos en el tratamiento de la úlcera del pie diabético. Material y método: estudio observacional, descriptivo, retrospectivo de pacientes asistidos en la Unidad de Pie del Hospital de Clínicas, Universidad de la República, entre octubre de 2014 y septiembre de 2016. Se estimaron gastos directos del tratamiento ambulatorio e internación a través de información de la historia clínica. El horizonte de tratamiento fue de tres meses. Se calcularon los gastos en unidades reajustables (UR), pesos y dólares. Los gastos se actualizaron a octubre del 2022 utilizando el índice de precios al consumo (IPC), ajustado a la tasa de inflación acumulada. Resultados: incluimos 49 pacientes, 11 mujeres y 38 hombres, edad promedio 61,5 años. El gasto general fue mayor a 400.000 dólares, con el mayor costo en gastos de internación. El gasto total promedio por paciente fue de 8.799 dólares. El tratamiento convencional fue 3.707,93 dólares, la amputación mayor 32.003,61 dólares y amputación menor 12.385,34 dólares. El gasto en internación fue muy superior al del paciente ambulatorio. En emergencia, 28 pacientes gastaron 4.396 dólares. El incremento de costos al año 2022 fue de 37,45%, suponiendo un gasto general de 16.682.993,4 pesos o 410.830,2 dólares. Conclusión: primera evaluación en nuestro país de estimación de gastos en pie diabético. El costo de la úlcera genera una carga económica notoria y en aumento. La gravedad inicial de la úlcera determina ingresos con elevados costes. Los gastos de internación y amputaciones representan la mayor erogación económica.

On a global scale, a diabetic patient incurs healthcare expenses that are 2 to 3 times higher than those of a non-diabetic individual. Diabetic foot syndrome reduces the quality of life, increases morbidity and mortality, and places an economic burden on the healthcare system. Objective: Communicating the research conducted on direct costs in the treatment of diabetic foot ulcers. Method: Observational, descriptive, retrospective study of patients treated at the Foot Unit of the Hospital de Clínicas (UDELAR) between October 2014 and September 2016. Direct treatment costs for outpatient care and hospitalization were estimated using information from the medical records. The treatment horizon extended over a period of 3 months. Expenses were calculated in readjustable units, Uruguayan pesos (UYU), and United States dollars (USD). Expenses were updated to October 2022 using the Consumer Price Index (IPC) adjusted for the cumulative inflation rate. Results: 49 patients were included in the study: 11 women and 38 men, average age was 61.5 years old. The overall expenditure exceeded 400,000 USD, with the highest cost attributed to hospitalization expenses. The average total expenditure per patient amounted to 8,799 USD. The cost of conventional treatment was 3,707.93 USD, major amputation represented USD 32,003.61, and minor amputation USD 12,385.34. Hospitalization expenses significantly exceeded those of outpatient care. In the emergency department, 28 patients spent USD 4,396. The increase in costs by the year 2022 amounted to 37.45%, resulting in a total expenditure of UYU 16,682,993.4 (Uruguayan pesos) or USD 410,830.2. Conclusions: It was the first assessment in our country to estimate diabetic foot costs. The cost of ulcer management imposes a significant and increasing economic burden. The initial severity of the ulcer results in hospitalization which implies high associated costs. Hospitalization and amputation costs constitute the most substantial economic expenditure.

Em todo o mundo, um paciente diabético gasta entre 2 e 3 vezes mais do que um paciente não diabético. O pé diabético reduz a qualidade de vida, aumenta a morbimortalidade e a carga económica no sistema de saúde. Objetivos: Comunicar os resultados da pesquisa realizada sobre os custos diretos no tratamento das úlceras do pé diabético. Materiais e métodos: Estudo observacional, descritivo e retrospectivo de pacientes atendidos na Unidade de Pie do Hospital de Clínicas (UDELAR), entre outubro de 2014 e setembro de 2016. Foram estimados gastos diretos com tratamento ambulatorial e internação, por meio de informações do prontuário do paciente. O período de tratamento estudado foi de 3 meses. As despesas foram calculadas em Unidades Ajustáveis, em pesos uruguaios (UYU) e em dólares norte-americanos (USD). As despesas foram atualizadas para outubro de 2022 pelo Índice de Preços ao Consumidor (IPC) ajustado à inflação acumulada. Resultados: Foram incluídos 49 pacientes: 11 mulheres e 38 homens com idade média de 61,5 anos. A despesa global foi superior a US$ 400.000, com o maior custo em despesas de hospitalização. A despesa total média por paciente foi de US$ 8.799. Os custos por tratamento foram: Tratamento convencional US$ 3.707,93 USD, amputação maior US$ 32.003,61 e amputação menor US$ 12.385,34. O gasto com internação foi muito superior ao do ambulatório. No atendimento de emergência 28 pacientes gastaram US$ 4.396. O aumento dos custos até 2022 foi de 37,45%, assumindo uma despesa geral de UY$ 16.682.993,4 ou US$ 410.830,2 USD. Conclusão: Esta é a primeira avaliação de estimativa de gastos com pé diabético realizada no Uruguai. O custo das úlceras gera uma carga económica notável e crescente. A gravidade inicial da úlcera determina internações com custos elevados. As despesas com hospitalização e amputação representam o maior gasto financeiro.

Cost-Effectiveness of Lower Extremity Nerve Decompression Surgery in the Prevention of Ulcers and Amputations: A Markov Analysis.

BACKGROUND: The costs and health effects associated with lower extremity complications in diabetes mellitus are an increasing burden to society. In selected patients, lower extremity nerve decompression is able to reduce symptoms of neuropathy and the concomitant risks of diabetic foot ulcers and amputations. To estimate the health and economic effects of this type of surgery, the cost-effectiveness of this intervention compared to current nonsurgical care was studied. METHODS: To estimate the incremental cost-effectiveness of lower extremity nerve decompression over a 10-year period, a Markov model was developed to simulate the onset and progression of diabetic foot disease in patients with diabetes and neuropathy who underwent lower extremity nerve decompression surgery, compared to a group undergoing current nonsurgical care. Mean survival time, health-related quality of life, presence or risk of lower extremity complications, and in-hospital costs were the outcome measures assessed. Data from the Rotterdam Diabetic Foot Study were used as current care, complemented with information from international studies on the epidemiology of diabetic foot disease, resource use, and costs, to feed the model. RESULTS: Lower extremity nerve decompression surgery resulted in improved life expectancy (88,369.5 life-years versus 86,513.6 life-years), gain of quality-adjusted life-years (67,652.5 versus 64,082.3), and reduced incidence of foot complications compared to current care (490 versus 1087). The incremental cost-effectiveness analysis was -€59,279.6 per quality-adjusted life-year gained, which is below the Dutch critical threshold of less than €80,000 per quality-adjusted life-year. CONCLUSIONS: Decompression surgery of lower extremity nerves improves survival, reduces diabetic foot complications, and is cost saving and cost-effective compared with current care, suggesting considerable socioeconomic benefit for society.

Patient perspectives on the physical, psycho-social, and financial impacts of diabetic foot ulceration and amputation.

AIMS: Diabetic foot ulcers (DFUs) and ulceration are complex and lifelong problems for patients with diabetes which dramatically increase mortality rates. This qualitative study sought to capture detailed personal accounts and insights from patients with a clinical history of DFUs and amputations to better understand patient experiences. METHODS: Fifteen patients from a tertiary referral center that treats diabetic foot problems were approached for participation. Inclusion criteria included having at least one DFU and being of white, Native American, or Hispanic background. Interviews were conducted by telephone by study staff trained in qualitative data gathering and audio recorded. RESULTS: The main themes that emerged around impacts included the heavy burden of managing care, significant loss of ambulatory function, economic stress due to medical care costs and job loss, and emotional suffering tied to these stressors. CONCLUSIONS: These data illuminate common social and personal impacts of diabetic foot problems across an ethnically and racially diverse and predominantly low-income US sample that expand our understanding of related declines in well-being. Our results indicate a need for proactive mental health assessment post DFUs diagnosis and the diversification of hospital and community-based support systems.

Human Wound and Its Burden: Updated 2020 Compendium of Estimates.

Significance: Chronic wounds impact the quality of life (QoL) of nearly 2.5% of the total population in the United States and the management of wounds has a significant economic impact on health care. Given the aging population, the continued threat of diabetes and obesity worldwide, and the persistent problem of infection, it is expected that chronic wounds will continue to be a substantial clinical, social, and economic challenge. In 2020, the coronavirus disease (COVID) pandemic dramatically disrupted health care worldwide, including wound care. A chronic nonhealing wound (CNHW) is typically correlated with comorbidities such as diabetes, vascular deficits, hypertension, and chronic kidney disease. These risk factors make persons with CNHW at high risk for severe, sometimes lethal outcomes if infected with severe acute respiratory syndrome coronavirus 2 (pathogen causing COVID-19). The COVID-19 pandemic has impacted several aspects of the wound care continuum, including compliance with wound care visits, prompting alternative approaches (use of telemedicine and creation of videos to help with wound dressing changes among others), and encouraging a do-it-yourself wound dressing protocol and use of homemade remedies/substitutions. Recent Advances: There is a developing interest in understanding how the social determinants of health impact the QoL and outcomes of wound care patients. Furthermore, addressing wound care in the light of the COVID-19 pandemic has highlighted the importance of telemedicine options in the continuum of care. Future Directions: The economic, clinical, and social impact of wounds continues to rise and requires appropriate investment and a structured approach to wound care, education, and related research.

Health service organisation impact on lower extremity amputations in people with type 2 diabetes with foot ulcers: systematic review and meta-analysis.

AIMS: Despite the evidence available on the epidemiology of diabetic foot ulcers and associated complications, it is not clear how specific organizational aspects of health care systems can positively affect their clinical trajectory. We aim to evaluate the impact of organizational aspects of care on lower extremity amputation rates among people with type 2 diabetes affected by foot ulcers. METHODS: We conducted a systematic review of the scientific literature published between 1999 and 2019, using the following key terms as search criteria: people with type 2 diabetes, diagnosed with diabetic foot ulcer, treated with specific processes and care pathways, and LEA as primary outcome. Overall results were reported as pooled odds ratios and 95% confidence intervals obtained using fixed and random effects models. RESULTS: A total of 57 studies were found eligible, highlighting the following arrangements: dedicated teams, care pathways and protocols, multidisciplinary teams, and combined interventions. Among them, seven studies qualified for a meta-analysis. According to the random effects model, interventions including any of the four arrangements were associated with a 29% reduced risk of any type of lower extremity amputation (OR = 0.71; 95% CI 0.52-0.96). The effect was larger when focusing on major LEAs alone, leading to a 48% risk reduction (OR = 0.52; 95% CI 0.30-0.91). CONCLUSIONS: Specific organizational arrangements including multidisciplinary teams and care pathways can prevent half of the amputations in people with diabetes and foot ulcers. Further studies using standardized criteria are needed to investigate the cost-effectiveness to facilitate wider implementation of improved organizational arrangements. Similarly, research should identify specific roadblocks to translating evidence into action. These may be structures and processes at the health system level, e.g. availability of professionals with the right skillset, reimbursement mechanisms, and clear organizational intervention implementation guidelines.

Cost-effectiveness of TLC-NOSF dressings versus neutral dressings for the treatment of diabetic foot ulcers in France.

This study assesses the cost-effectiveness of Technology Lipido-Colloid with Nano Oligo Saccharide Factor (TLC-NOSF) wound dressings versus neutral dressings in the management of diabetic foot ulcers (DFUs) from a French collective perspective. We used a Markov microsimulation cohort model to simulate the DFU monthly progression over the lifetime horizon. Our study employed a mixed method design with model inputs including data from interventional and observational studies, French databases and expert opinion. The demographic characteristics of the simulated population and clinical efficacy were based on the EXPLORER double-blind randomized controlled trial. Health-related quality of life, costs, and resource use inputs were taken from the literature relevant to the French context. The main outcomes included life-years without DFU (LYsw/DFU), quality-adjusted life-years (QALYs), amputations, and lifetime costs. To assess the robustness of the results, sensitivity and subgroup analyses based on the wound duration at treatment initiation were performed. Treatment with the TLC-NOSF dressing led to total cost savings per patient of EUR 35,489, associated with gains of 0.50 LYw/DFU and 0.16 QALY. TLC-NOSF dressings were established as the dominant strategy in the base case and all sensitivity analyses. Furthermore, the model revealed that, for every 100 patients treated with TLC-NOSF dressings, two amputations could be avoided. According to the subgroup analysis results, the sooner the TLC-NOSF treatment was initiated, the better were the outcomes, with the highest benefits for ulcers with a duration of two months or less (+0.65 LYw/DFU, +0.23 QALY, and cost savings of EUR 55,710). The results from the French perspective are consistent with the ones from the German and British perspectives. TLC-NOSF dressings are cost-saving compared to neutral dressings, leading to an increase in patients' health benefits and a decrease in the associated treatment costs. These results can thus be used to guide healthcare decisionmakers. The potential savings could represent EUR 3,345 per treated patient per year and even reach EUR 4,771 when TLC-NOSF dressings are used as first line treatment. The EXPLORER trial is registered with ClinicalTrials.gov, number NCT01717183.

Technology-enabled remote management of diabetes foot disease and potential for reduction in associated health costs: a pilot study.

Diabetes-related foot disease, particularly when associated with amputation, affects quality of life and has a significant impact on health care costs. A pilot study using enhanced technology to facilitate remote access and video conferencing from rural locations to the diabetes MDT through a new service pathway confirmed high levels of patient satisfaction with 89% of foot ulcers improved or stable and only two minor amputations. A health economic analysis suggested potential for significant cost savings if this was scaled up regionally. Further evaluation of an integrated pathway, impact on lower limb amputation rates and full health economic assessment is recommended.

Clinical and economic burden of diabetic foot ulcers: A 5-year longitudinal multi-ethnic cohort study from the tropics.

Diabetic foot ulcers (DFUs) present a substantial clinical and economic burden to healthcare systems around the world, with significant reductions in quality of life for those affected. We aimed to analyse the clinical and economic burden of DFU via a 5-year longitudinal multi-ethnic cohort study. A longitudinal analysis of inpatient and outpatient DFUs data over 5 years from a university tertiary hospital in Singapore was performed. Data included baseline characteristics, clinical outcomes, hospitalisation, and outpatient details. Descriptive statistics, Kaplan-Meier survival analyses, and Cox proportional hazard models were performed. Patients treated for DFUs (n = 1729, mean patient age of 63·4 years) were assessed. The cohort consists of Chinese (61.4%), Malay (13.5%), and Indian (18.4%) patients. Common comorbidities included peripheral arterial disease (74.8%), peripheral neuropathy (14.5%), and a median haemoglobin A1c of 9.9%. Patients underwent toe(s) amputation (36.4%), transmetatarsal amputations (16.9%), or major amputations (6·5%). The mean length of inpatient stay for ulcer-only, minor amputation, and major amputation was 13.3, 20.5, and 59.6 days, respectively. Mean cost per patient-year was US $3368 (ulcer-only), US $10468 (minor amputation), and US $30131 (major amputation). Minor amputation-free survival was 80.9% at 1 year and 56.9% at 5 years, while major amputation-free survival was 97.4% at 1 year and 91.0% at 5 years. In conclusion, within our multi-ethnic cohort of patients from the tropics, there was significant clinical and economic burden of DFUs, with a high wound per patient ratio and escalating healthcare costs corresponding to more proximal amputation levels.

The Neuro-Vascular Consequence of Diabetes: Foot Amputation and Evaluation of its Risk Factors and Health-Related Economic Impact.

BACKGROUND: The rising prevalence of type 2 diabetes mellitus (T2DM) with the huge burden of diabetic foot amputation is a challenge to the health economy of Pakistan and other countries. Identification of various risk factors for amputation, along with its financial burden, is needed to address this problem. OBJECTIVES: This study aimed to determine the financial burden and risk factors associated with T2DMrelated foot amputation. METHODS: Retrospective hospital-based study from January 2017 to December 2018. Patients with T2DM with and without amputation were enrolled. The direct medical costs of amputation along with various risk factors, were determined. Risk factors were evaluated by logistic regression analysis. RESULTS: A total of 1460 patients with T2DM were included; 484 (33%) patients had an amputation. The mean total cost of below knee, fingers and toe amputation was 886.63±23.91, 263.35 ±19.58 and 166.68 ± 8.47 US$, respectively. This difference among groups was significant (p<0.0001). Male gender (odds ratio, OR: 1.29, 1.01-1.63, p=0.037), peripheral artery disease (OR: 1.93, 1.52-2.46, p=0.000), peripheral neuropathy (OR: 1.31, 1.40-1.63, p=0.000), prior diabetic foot ulcer (OR: 2.02, 1.56- 2.56, p=0.000) and raised glycated haemoglobin (HbA1c) (OR: 3.50, 2.75-4.4, p=0.000) were risk factors for amputation. CONCLUSION: The health-related financial impact of amputations is high. Peripheral artery disease, peripheral neuropathy, prior diabetic foot ulcer and raised HbA1c were risk factors for amputation.

Health Care Spending in Patients With Stage 3 and Stage 4 Pressure Injuries and Patients With Diabetic Foot Ulcers Treated Early With Clostridial Collagenase Ointment: A Retrospective Data Review.

INTRODUCTION: Clostridial collagenase ointment (CCO) is the only enzymatic agent indicated for debriding chronic dermal ulcers that is approved by the United States Food and Drug Administration. OBJECTIVE: The objective of this study is to estimate health care spending among patients with Stage 3 and Stage 4 pressure injuries (PIs) and patients with diabetic foot ulcers (DFUs) who experienced early (ie, within 30 days of index diagnosis) versus late (31 to 90 days of index diagnosis) initiation of CCO. METHODS: Patients with PIs and DFUs between January 2007 and March 2017 were identified. One-to-one matched cohorts were used to compare all-cause health care spending and disease-related health care spending between the early initiation and late initiation groups. RESULTS: Compared to the early CCO initiation group, all-cause health care spending for the late CCO initiation group was higher in both patients with PIs and in patients with DFUs within the 12-month follow-up period. Compared to the early CCO initiation group, disease-related health care spending for the late CCO initiation group was higher in both patients with PIs and in patients with DFUs within the 12-month follow-up period. All computations were statistically significant. CONCLUSIONS: Early initiation of CCO provides both all-cause and disease-related health care savings to payers and persons managing patients with PIs or DFUs. Payers, providers, and facilities should consider mechanisms to encourage the early use of CCO to lower costs.

Preliminary Experience with Conservative Sharp Wound Debridement by Nurses in the Outpatient Management of Diabetic Foot Ulcers: Safety, Efficacy, and Economic Analysis.

Background: Treatment of diabetes costs the United States an estimated $245 billion annually; one-third of which is related to the treatment of diabetic foot ulcers (DFUs). We present a safe, efficacious, and economically prudent model for the outpatient treatment of uncomplicated DFUs. Methods: 77 patients (mean age = 54 years, range 31 to 83) with uncomplicated DFUs prospectively enrolled from September 2008 through February 2012. All patients received an initial sharp debridement by one of two orthopaedic foot and ankle fellowship trained surgeons. Ulcer dressings, offloading devices, and debridement procedures were standardized. Patients were evaluated every two weeks by research nurses who utilized a clinical management algorithm and performed conservative sharp wound debridement (CSWD). Results: Average time to clinical healing was 6.0 weeks. There were no complications of CSWD performed by nurses. The sensitivity for the timely identification of wound deterioration was 100%, specificity = 86.49%, PPV = 68.75% and NPV = 100% with an overall accuracy of 89.58%. The estimated cost savings in this model by having nurses perform CSWD was $223.26 per encounter, which, when extrapolated to national estimates, amounts to $1.56 billion to $2.49 billion in potential annual savings across six to ten-week treatment periods, respectively. Conclusion: CSWD of DFUs by nurses in a vertically integrated multidisciplinary team is a safe, effective, and fiscally responsible clinical practice. This clinical model on a national scale could result in significant healthcare savings. Surgeons and other licensed independent practitioners would have more time for evaluating and treating more complex and operative patients; nurses would be practicing closer to the full extent of their education and training as allowed in most states.Level of Evidence: III.

Is Reconstruction of Unstable Midfoot Charcot Neuroarthropathy Cost Effective from a US Payer's Perspective?

BACKGROUND: Charcot neuroarthropathy is a morbid and expensive complication of diabetes that can lead to lower extremity amputation. Current treatment of unstable midfoot deformity includes lifetime limb bracing, primary transtibial amputation, or surgical reconstruction of the deformity. In the absence of a widely adopted treatment algorithm, the decision to pursue more costly attempts at reconstruction in the United States continues to be driven by surgeon preference. QUESTIONS/PURPOSES: To examine the cost effectiveness (defined by lifetime costs, quality-adjusted life-years [QALYs] and incremental cost-effectiveness ratio [ICER]) of surgical reconstruction and its alternatives (primary transtibial amputation and lifetime bracing) for adults with diabetes and unstable midfoot Charcot neuroarthropathy using previously published cost data. METHODS: A Markov model was used to compare Charcot reconstruction and its alternatives in three progressively worsening clinical scenarios: no foot ulcer, uncomplicated (or uninfected) ulcer, and infected ulcer. Our base case scenario was a 50-year-old adult with diabetes and unstable midfoot deformity. Patients were placed into health states based on their disease stage. Transitions between health states occurred annually using probabilities estimated from the evidence obtained after systematic review. The time horizon was 50 cycles. Data regarding costs were obtained from a systematic review. Costs were converted to 2019 USD using the Consumer Price Index. The primary outcomes included the long-term costs and QALYs, which were combined to form ICERs. Willingness-to-pay was set at USD 100,000/QALY. Multiple sensitivity analyses and probabilistic analyses were performed to measure model uncertainty. RESULTS: The most effective strategy for patients without foot ulcers was Charcot reconstruction, which resulted in an additional 1.63 QALYs gained and an ICER of USD 14,340 per QALY gained compared with lifetime bracing. Reconstruction was also the most effective strategy for patients with uninfected foot ulcers, resulting in an additional 1.04 QALYs gained, and an ICER of USD 26,220 per QALY gained compared with bracing. On the other hand, bracing was cost effective in all scenarios and was the only cost-effective strategy for patents with infected foot ulcers; it resulted in 6.32 QALYs gained and an ICER of USD 15,010 per QALY gained compared with transtibial amputation. As unstable midfoot Charcot neuroarthropathy progressed to deep infection, reconstruction lost its value (ICER USD 193,240 per QALY gained) compared with bracing. This was driven by the increasing costs associated with staged surgeries, combined with a higher frequency of complications and shorter patient life expectancies in the infected ulcer cohort. The findings in the no ulcer and uncomplicated ulcer cohorts were both unchanged after multiple sensitivity analyses; however, threshold effects were identified in the infected ulcer cohort during the sensitivity analysis. When the cost of surgery dropped below USD 40,000 or the frequency of postoperative complications dropped below 50%, surgical reconstruction became cost effective. CONCLUSIONS: Surgeons aiming to offer both clinically effective and cost-effective care would do well to discuss surgical reconstruction early with patients who have unstable midfoot Charcot neuroarthropathy, and they should favor lifetime bracing only after deep infection develops. Future clinical studies should focus on methods of minimizing surgical complications and/or reducing operative costs in patients with infected foot ulcers. LEVEL OF EVIDENCE: Level II, economic and decision analysis.

National and State-Level Trends in Nontraumatic Lower-Extremity Amputation Among U.S. Medicare Beneficiaries With Diabetes, 2000-2017.

OBJECTIVE: Diabetes is a leading cause of nontraumatic lower-extremity amputation (NLEA) in the U.S. After a period of decline, some national U.S. data have shown that diabetes-related NLEAs have recently increased, particularly among young and middle-aged adults. However, the trend for older adults is less clear. RESEARCH DESIGN AND METHODS: To examine NLEA trends among older adults with diabetes (≥67 years), we used 100% Medicare claims for beneficiaries enrolled in Parts A and B, also known as fee for service (FFS). NLEA was defined as the highest-level amputation per patient per calendar year. Annual NLEA rates were estimated from 2000 to 2017 and stratified by age-group, sex, race/ethnicity, NLEA level (toe, foot, below-the-knee amputation [BKA], or above-the-knee amputation [AKA]), and state. All rates were age and sex standardized to the 2000 Medicare population. Trends over time were assessed using Joinpoint regression and annual percent change (APC) reported. RESULTS: NLEA rates (per 1,000 people with diabetes) decreased by half from 8.5 in 2000 to 4.4 in 2009 (APC -7.9, P < 0.001). However, from 2009 onward, NLEA rates increased to 4.8 (APC 1.2, P < 0.01). Trends were similar across most age, sex, and race/ethnic groups, but absolute rates were highest in the oldest age-groups, Blacks, and men. By NLEA type, overall increases were driven by increases in rates of toe and foot NLEAs, while BKA and AKA continued to decline. The majority of U.S. states showed recent increases in NLEA, similar to national estimates. CONCLUSIONS: This study of the U.S. Medicare FFS population shows that recent increases in diabetes-related NLEAs are also occurring in older populations but at a less severe rate than among younger adults (<65 years) in the general population. Preventive foot care has been shown to reduce rates of NLEA among adults with diabetes, and the findings of the study suggest that those with diabetes-across the age spectrum-could benefit from increased attention to this strategy.

Economic evaluations considering costs and outcomes of diabetic foot ulcer infections: A systematic review.

BACKGROUND: Diabetic foot ulcer (DFU) is a severe complication of diabetes and particularly susceptible to infection. DFU infection intervention efficacy is declining due to antimicrobial resistance and a systematic review of economic evaluations considering their economic feasibility is timely and required. AIM: To obtain and critically appraise all available full economic evaluations jointly considering costs and outcomes of infected DFUs. METHODS: A literature search was conducted across MedLine, CINAHL, Scopus and Cochrane Database seeking evaluations published from inception to 2019 using specific key concepts. Eligibility criteria were defined to guide study selection. Articles were identified by screening of titles and abstracts, followed by a full-text review before inclusion. We identified 352 papers that report economic analysis of the costs and outcomes of interventions aimed at diabetic foot ulcer infections. Key characteristics of eligible economic evaluations were extracted, and their quality assessed against the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. RESULTS: 542 records were screened and 39 full-texts assessed for eligibility. A total of 19 papers were included in the final analysis. All studies except one identified cost-saving or cost-effective interventions. The evaluations included in the final analysis were so heterogeneous that comparison of them was not possible. All studies were of "excellent", "very good" or "good" quality when assessed against the CHEERS checklist. CONCLUSIONS: Consistent identification of cost-effective and cost-saving interventions may help to reduce the DFU healthcare burden. Future research should involve clinical implementation of interventions with parallel economic evaluation rather than model-based evaluations.