Non-traumatic Lower Extremity Amputations Research Articles

Declining Incidence of Major Lower-Extremity Amputations in the Northern Danish Region Between 2016 and 2021: The Impact of Diabetes and Preventive Vascular Procedures

BackgroundPreventing lower-extremity amputations (LEAs) is pivotal. In the present study we aimed to examine the recent trends in non-traumatic LEAs seen in the Northern Danish Region. MethodsUsing data from the regional Business Intelligence unit we identified all non-traumatic LEAs (n=689) performed in people above 50 years of age in the Northern Danish Region between January 2016 and December 2021 (approximately 600.000 inhabitants). Persons with diabetes (n=26,025) were identified based on ICD-10 codes and data from The National Health Insurance Service Registry, while preventive vascular procedures (n=1,097) were identified using surgical codes. Major LEA was defined as any amputation above the ankle. Incidence rates were expressed as events per 1.000 person-years. Trends were described as differences between the periods 2016-2018 and 2019-2021. ResultsA total of 249 (36%) major LEAs were performed in people with diabetes. People with diabetes were younger (71 vs 77 years, p<0.001) and more frequently male (70% versus 54%, p<0.001). Between 2016-2018 and 2019-2021 the incidence of major LEA declined from 1.76 (95% CI: 1.75-1.76) to 1.39 (1.39-1.39) in people with diabetes, and from 0.47 (0.47-0.47) to 0.20 (0.20-0.20) in people without diabetes (all p<0.001). Simultaneously, the incidence of preventive vascular surgery increased from 2.26 (2.26-2.26) to 3.48 (3.48-3.48) in people with diabetes and declined slightly in people without 0.49 (0.49-0.49) to 0.47 (0.47-0.47) (all p<0.001). ConclusionDespite significant declines in major LEA in both people with and without diabetes, most of the decline was driven by a large reduction in major LEAs in people without diabetes. Diabetic foot, lower extremity amputation, major amputation, minor amputation, preventive vascular procedures, revascularization, vascular surgery.

Trends and Inequalities in Diabetes-Related Complications Among U.S. Adults, 2000-2020.

We examined national trends in diabetes-related complications (heart failure [HF], myocardial infarction [MI], stroke, end-stage renal disease [ESRD], nontraumatic lower-extremity amputation [NLEA], and hyperglycemic crisis) among U.S. adults with diagnosed diabetes during 2000-2020 by age-group, race and ethnicity, and sex. We also assessed trends in inequalities among those subgroups. Hospitalization rates for diabetes-related complications among adults (≥18 years) were estimated using the 2000-2020 National (Nationwide) Inpatient Sample. The incidence of diabetes-related ESRD was estimated using the United States Renal Data System. The number of U.S. adults with diagnosed diabetes was estimated from the National Health Interview Survey. Annual percent change (APC) was estimated for assessment of trends. After declines in the early 2000s, hospitalization rates increased for HF (2012-2020 APC 3.9%, P < 0.001), stroke (2009-2020 APC 2.8%, P < 0.001), and NLEA (2009-2020 APC 5.9%, P < 0.001), while ESRD incidence increased (2010-2020 APC 1.0%, P = 0.044). Hyperglycemic crisis increased from 2000 to 2020 (APC 2.2%, P < 0.001). MI hospitalizations declined during 2000-2008 (APC -6.0%, P < 0.001) and were flat thereafter. On average, age inequalities declined for hospitalizations for HF, MI, stroke, and ESRD incidence but increased for hyperglycemic crisis. Sex inequalities increased on average for hospitalizations for stroke and NLEA and for ESRD incidence. Racial and ethnic inequalities declined during 2012-2020 for ESRD incidence but increased for HF, stroke, and hyperglycemic crisis. There was a continued increase of several complications in the past decade. Age, sex, and racial and ethnic inequalities have worsened for some complications.

Health Care Delays and Social Suffering Among Indigenous People with Diabetic Foot Complications in Mexico

ABSTRACT Diabetic foot (DF) is a leading cause of nontraumatic lower-extremity amputations, premature death, and a sign of social inequality in diabetes treatment. In Mexico, the incidence of DF is on the rise yet little is known about its impact among indigenous people, a disadvantaged group. Based on ethnographic research conducted in Oaxaca and analysis of institutional health-data, in this article we show the health care delays that rural indigenous people face when dealing with DF. Indigenous people’s uncertainty regarding their right to health and the structural barriers to medical care favor DF complications, a phenomenon that should be read as social suffering. Since health data concerning indigenous health care service users is patchy and imprecise, indigenous people's social suffering is invisibilized. This omission or partiality in the official records limits public health decision-making and undermines the human rights of the population.

Prevalence of diabetic kidney disease and the associated factors among patients with type 2 diabetes in a multi-ethnic Asian country

The actual prevalence of diabetic kidney disease (DKD) in patients with type 2 diabetes (T2D) in Malaysia is unknown. We aimed to determine the prevalence of DKD and its associated risk factors among T2D patients in Malaysia. An analytical cross-sectional study was conducted using the year 2022 clinical audit dataset from the National Diabetes Registry. DKD was defined as albuminuria, a decreased glomerular filtration rate, or both. Among 80,360 patients, 62.2% were female, 68.4% were Malay, and the mean age was 61.4 years. A total of 56.7% (95% CI 56.4–57.1%) of patients were found to have DKD. Increasing age, male sex, Malay ethnicity, longer duration of diabetes, overweight, obesity, hypertension, diabetic retinopathy, diabetic foot ulcer, nontraumatic lower-extremity amputation, ischaemic heart disease, stroke, insulin, higher numbers of antihypertensive agents, antiplatelet agents, poorer HbA1c control, higher systolic blood pressure, non-achievement of triglyceride target, and non-attainment of HDL-cholesterol goal were independent risk factors associated with DKD. Clinicians, program managers, and health policymakers should target modifiable factors to manage DKD and prevent its progression to end-stage kidney disease in Malaysia.

Effectiveness of a Multidisciplinary Limb Preservation Program in Reducing Regional Hospitalization Rates for Patients With Diabetes-Related Foot Complications.

This study evaluated the toe and flow model (TFM), a limb preservation program led by podiatric surgeons in Alberta, Canada, for its impact on hospitalization rates and length of stay (LOS) in patients with diabetic foot complication (DFC). Diabetes, a leading cause of non-traumatic lower extremity amputations (LEAs) in Canada, often results in diabetic foot ulcers (DFUs), a major cause of infection, amputation, and hospitalization. TFM has reportedly reduced amputation rates by 39% to 56%. The study analyzed Alberta's health database from 2007 to 2017, focusing on diabetes patients aged 20 and above. It included patients with various DFCs and compared outcomes in regions using TFM and standard of care (SOC). The study also examined data from two major cities, one with TFM and the other without, including rural referrals to Calgary and Edmonton. The data were normalized for the diabetic population and analyzed using a standard Student's t-test. TFM regions showed significantly lower hospitalization rates (p = 1.22E-12) than SOC regions. Over 11 years, TFM maintained lower average and median LOS by 0.13 and 0.26 days, respectively. TFM access reduced hospitalization risk by up to 30%, and patients in TFM regions had a 21% shorter LOS compared to SOC regions. Despite similar demographics and healthcare systems, the TFM region benefited from a dedicated multidisciplinary program and comprehensive limb preservation services. The study shows that TFM effectively reduces hospitalizations and LOS for DFCs, with significantly better outcomes in the TFM region than in SOC regions.

A tool to predict the risk of lower extremity amputation in patients starting dialysis.

Non-traumatic lower extremity amputation (LEA) is a severe complication during dialysis. To inform decision-making for physicians, we developed a multivariable prediction model for LEA after starting dialysis. Data from the Swedish Renal Registry (SNR) between 2010 and 2020 were geographically split into a development and validation cohort. Data from NECOSAD between 1997 and 2009 were used for validation targeted at Dutch patients. Inclusion criteria were no previous LEA and kidney transplant and age≥40 years at baseline. A Fine-Gray model was developed with LEA within 3 years after starting dialysis as outcome of interest. Death and kidney transplant were treated as competing events. One coefficient, ordered by expected relevance, per 20 events was estimated. Performance was assessed with calibration and discrimination. SNR was split into an urban development cohort with 4771 individuals experiencing 201 (4.8%) events and a rural validation cohort with 4.876 individuals experiencing 155 (3.2%) events. NECOSAD contained 1658 individuals experiencing 61 (3.7%) events. Ten predictors were included: female sex, age, diabetes mellitus, peripheral artery disease, cardiovascular disease, congestive heart failure, obesity, albumin, haemoglobin and diabetic retinopathy. In SNR, calibration intercept and slope were -0.003 and 0.912 respectively. The C-index was estimated as 0.813 (0.783-0.843). In NECOSAD, calibration intercept and slope were 0.001 and 1.142 respectively. The C-index was estimated as 0.760 (0.697-0.824). Calibration plots showed good calibration. A newly developed model to predict LEA after starting dialysis showed good discriminatory performance and calibration. By identifying high-risk individuals this model could help select patients for preventive measures.

The Effect of Limb Salvage Efforts in Different Age Groups: Relationships Between Major and Minor Amputations

“Limb salvage” efforts, such as performing minor amputations before infections spread proximally from the foot to decrease major lower extremity amputation, are an important part of healthcare today. It is unclear whether these efforts are preventing the number of major amputations and improving patients’ quality of life and the cost-effectiveness of the U.S. healthcare system. Rates of non-traumatic lower extremity amputation (NLEA) among patients with diabetes decreased in the early 2000s but rebounded in the 2010s. We analyzed the proportion of major amputations and differences in amputation rates between age groups in Texas. Patient data was extracted from the Texas Hospital Discharge Data Public Use Data File. Population estimates were obtained from the Texas Population Estimates Program from 2011 to 2015 and from intercensal estimates provided by the U.S. Census Bureau from 2006 to 2010. Raw numbers of minor, major, and all NLEA surgeries and the ratio of major amputations to total amputations per year were reported for each age group. Poisson regression and Joinpoint analyses were performed to capture these changes in trends. Rates of amputations increased, with significant decreasing relative prevalence of major amputations. Patients aged 45 to 64 with diabetes are likely driving these increases. Rates of lower extremity amputation in patients with diabetes increased from 2009 to 2015. This holds for all and minor amputations. In contrast, the ratio of major to all amputations decreased from 2010. Utilization of major and minor amputation differs between age groups, remaining stable in the youngest subjects, with minor amputation rates increasing in those aged 45 to 64.

Regional and racial disparities in major amputation rates among medicare beneficiaries with diabetes: a retrospective study in the southeastern USA

ObjectiveWhile rates for non-traumatic lower extremity amputations (LEA) have been declining, concerns exist over disparities. Our objectives are to track major LEA (MLEA) rates over time among Medicare beneficiaries residing...

Exploring the Indications, Levels, and Outcomes of Lower Extremity Amputation at a Tertiary Care Hospital in Pakistan.

Lower extremity amputation (LEA) is a surgical procedure performed to remove either a part or the entire lower limb due to medical conditions such as trauma, infection, peripheral vascular disease, or malignancy. The procedure is becoming increasingly common in Pakistan, with a bulk of patients presenting from rural areas in tertiary care centers. Understanding the indications, levels, and outcomes of LEA is essential for improving patient care and adopting preventive strategies, especially in developing countries. This study was conducted at Dow University Hospital in Karachi, Pakistan. Retrospective data of 384 patients who underwent non-traumatic lower extremity amputations between January 2016 and December 2020 was collected to include relevant history and characteristics, amputation indication and level, type of anesthesia used, and outcome within hospital stay. The data was analyzed using descriptive statistics. The data is composed of a wide age range (18 to 91 years) of patients, including a male majority (76.3%, n = 293). The employment status of the patients was taken into consideration, with a reported high number of unemployed individuals (60.4%, n = 232). Diabetes mellitus (84.4%, n = 324) was a commonly reported past medical condition, followed by hypertension (4.4%, n = 17). Indications for amputation exceedingly recorded were diabetic foot ulcers (84.4%, n = 324), followed by infections (9.4%, n = 36) and peripheral arterial disease (3.6%, n = 14). The anesthetic approach that was observed most in these patients was regional anesthesia (74.7%, n = 287). Right-sided amputations (52.9%, n = 203) were dominant, with below-knee amputations leading by the level of amputation performed (42.5%, n = 163). Many patients delayed seeking treatment (71.6%, n = 275) and indicated denial of severity (18%, n = 69) as a reason for the delay. Regarding outcome, many patients were successfully discharged following treatment (85.9%, n = 330). Overall, LEAs are being frequently performed in developing countries, such as Pakistan, especially with a large population living with diabetes mellitus. The implications of this disease are reflected in this study population, with the majority of patients reporting delays in treatment due to reasons such as the unknown severity of the disease or financial burdens. The challenges faced by these individuals, especially in this country, can be tackled with widespread affordability and availability of care and education on early management.

FRI618 Lifetime Risk Of Nontraumatic Lower-extremity Amputation

Abstract Disclosure: N. Ding: None. Y. Mok: None. M. Salameh: None. W. Tang: None. E. Selvin: None. K.R. Butler: None. K. Matsushita: None. Introduction: Nontraumatic lower-extremity amputation (NLEA) is mainly caused by diabetes and peripheral artery disease. Although the annual incidence of NLEA is generally well-documented, no lifetime risk estimates are currently available. Furthermore, it is unknown whether the estimates vary by sociodemographic characteristics. Methods: In 14,108 ARIC participants aged 45-64 at baseline (1987-89), we estimated the cumulative incidence of NLEA (identified from discharge ICD codes) in the lifespan from age 50 through 80 using Fine and Gray’s proportional subhazards models accounting for the competing risk of death. We also explored the lifetime risk of NLEA by sex, race, annual household income, and in participants with diabetes. Additionally, we estimated the cumulative mortality among participants with and without NLEA using Kaplan-Meier analysis, in the scheme of a 1:2 matched cohort study. Results: There were 226 NLEA cases during a median follow-up time of 30 years. The estimated overall lifetime risk of NLEA from 50 years of age was 1.5% (95% confidence interval [CI], 1.3%-1.7%). The lifetime risk was highest in Black men (4.2% [3.1%-5.5%]), followed by Black women (2.7% [2.1%-3.5%]), White men (1.1% [0.8%-1.5%]), and White women (0.7% [0.5%-0.9%]). When further categorized by income, Black men with low income showed the highest lifetime risk (5.2% [3.7%-7.0%]), while White men with high income had a lifetime risk of 0.9% (0.6%-1.2%). Diabetes drastically increased the risk of NLEA by 5-fold in each race-sex group. Black men with diabetes have a 14% risk of developing NLEA in their lifetime. In the matched cohort study, we included 225 participants with NLEA and 450 without NLEA. The 1-year mortality was 30.9% (25.3%-37.4%) among those with NLEA and 4.1% (2.6%-6.4%) among those without NLEA, while the 10-year mortality was 83.5% (77.7%-88.6%) among those with NLEA and 38.9% (34.2%-44.1%) among those without. Conclusions: In this community-based cohort, 3%-4% of Black individuals experienced NLEA during their lifetime, while 1% of White individuals did. The lifetime risk was enhanced in people with low income and diabetes. Those with NLEA had greater short-term and long-term mortality than those without. Future public health efforts to prevent limb loss should prioritize racial minorities, those with low socioeconomic status, and diabetes. Presentation: Friday, June 16, 2023

THU260 Development Of Plantar Thermography For Screening Of Diabetic Neuropathy

Abstract Disclosure: V. Panamonta: None. R. Jerawatana: None. P. Ariyaprayoon: None. P. Looareesuwan: None. B. Ongphiphadhanakul: None. C. Sriphrapradang: None. B. Ongphiphadhanakul: None. Background: Diabetic foot ulcers are a major complication of diabetes. They are also the leading cause of nontraumatic lower extremity amputation. The incidence of diabetic foot ulcers is highest in those patients with poor glycemic control and neuropathy. In people with diabetic neuropathy, the feet temperature may change due to decreased blood flow and nerve damage. Thermography has been proposed as a noninvasive modality to identify patients at risk for diabetic foot ulcers. In this study, we used thermography and deep learning to stratify patients with diabetes at risk for developing a foot ulcer. Methods: We prospectively record clinical data and plantar thermogram in adult diabetic patients underwent diabetic foot screening at outpatient clinics at Ramathibodi hospital, Bangkok, Thailand during September to December 2022. Altogether, there were 245 thermal images were analyzed using a deep learning algorithm to determine the risk for diabetic foot ulcers by transfer learning using the pre-trained VGG16 model which is a convolutional neural network for image recognition. Twenty percent of the images were set aside for testing purposes while 20% of the images served as the validation set during training of the neural network. The neural network was trained and weighed more toward higher sensitivity of identifying at risk feet for screening purpose. Results: The study sample consisted of individuals with a mean age of 62.5±12.5 years, 57.1% who had diabetes for more than 10 years. The majority of the participants were females (57.1%). The average body mass index (BMI) was 27.8±9.6 (kg/m2). There were 186 thermal images classified as category 0 and 59 images classified as categories 1 to 3 according to the American Diabetes Association risk classification. The trained neural network achieved 75 % accuracy with 95 % sensitivity and 67 % specificity for classifying thermograms as higher than normal risk in the training dataset. For the testing dataset, the sensitivity and specificity was 75% and 41%, respectively. The accuracy, however, decreased to 50% due mainly to the misclassification of normal thermograms from abnormal. Conclusions: These results suggest that thermography combined with deep learning could potentially be developed for screening purpose to stratify patients at risk of developing diabetic foot ulcers. Further research is needed to validate the results in larger datasets and to explore alternative algorithms for predicting diabetic foot ulcers. Presentation: Thursday, June 15, 2023

Microarray Expression Profile and Bioinformatic Analysis of Circular RNA in Human Arteriosclerosis Obliterans.

Arteriosclerosis obliterans (ASO) is the leading cause of nontraumatic lower-extremity amputations. Multiple researches have suggested that circular RNAs (circRNAs) played vital regulatory functions in cancer and cardiovascular disease. Nevertheless, the underlying effect and pathological mechanism of circRNAs in the formation and progression of ASO are still indistinct. This study used microarray analysis to investigate the expression portrait of circRNAs in normal lower extremity arteries and ASO arteries. Bioinformatics analysis was conducted using the KEGG database to study the enrichment of differentially expressed circRNAs (DE circRNAs) and predict their functions. The accuracy of microarray assay was verified by evaluating expression of the top 5 upregulated and 5 downregulated circRNAs (raw density of normal group ≥200) using RT-qPCR. A circRNA-miRNA-mRNA interaction network was further predicted using software. Compared to the normal lower extremity group, the ASO arteries with HE and EVG staining presented hyperplastic fibrous membrane and luminal stenosis. A total of 12,735 circRNAs were identified, including 1196 DE circRNAs with 276 upregulated and 920 downregulated in ASO group based on |log2(FC)| > 1 and padj < 0.05. Among selected 10 circRNAs, RT-qPCR confirmed that hsa_circ_0003266, hsa_circ_0118936 and hsa_circ_0067161 were upregulated while hsa_circ_0091934 and hsa_circ_0092022 were downregulated in ASO group (p < 0.05). GO analysis presented that the DE circRNAs were primarily enriched in protein binding, intracellular part and organelle organization. KEGG pathway analysis indicated that MAPK signaling pathway, human T-cell leukemia virus 1 infection, proteoglycans in cancer were associated with the DE circRNAs. The circRNA-miRNA-mRNA interactive network revealed that both mRNAs and miRNAs linked to circRNAs played an indispensable role in ASO. This study described the expression portrait of circRNAs in human ASO arteries, and revealed the molecular background for further investigations of the circRNA regulatory mechanism in the formation and progression of ASO.

Identifying barriers to preventive care among First Nations people at risk of lower extremity amputation: a qualitative study.

First Nations people in Canada are overrepresented among those who have undergone nontraumatic lower extremity amputation, and are more likely to be younger, have diabetic foot infections and have no previous revascularization procedures than non-First Nations populations who have undergone lower extremity amputations. We sought to identify access barriers for high-risk First Nations patients, explore patients' experiences with health care systems and identify solutions. Employing a community participatory research design, we engaged representatives from 2 communities. They assisted with research design and data analysis, and approved the final manuscript. Using a hermeneutic phenomenological approach and purposeful sampling, we conducted 5 semistructured focus groups between August and December 2021 with community health care teams and patients at risk for, or who had previously undergone, a nontraumatic lower extremity amputation. Patients' (n = 10) and community health care providers' (n = 18) perspectives indicated that barriers to health care access led to delayed care and increased complications and risk for lower extremity amputations, leading to aggressive procedures upon receiving care. Barriers to care led to negative experiences at urban centres and aggressive procedures created further distrust, leading to care disengagement and poor outcomes. Patients and providers both suggested building stronger partnerships between urban and rural health care providers, improving education for patients and health care providers and identifying innovative strategies to improve patients' overall health. Systemic changes, health promotional program and reliable on-reserve primary care are needed to create equitable access for First Nation patients at risk for lower extremity amputations. The study results imply that health care delivery for First Nations patients at risk for lower extremity amputations can be improved through stronger partnership and communication between urban and community providers, and continued education and cultural competency training for urban health care providers.

Incidence of Lower Extremity Amputation in Romania: A Nationwide 5-Year Cohort Study, 2015-2019.

Background and Objectives: The primary objective of this study was to investigate the incidence of lower extremity amputations (LEAs) in a representative population from Romania, in both diabetic and non-diabetic adults, including trauma-related amputations. The secondary objective was to evaluate the trends in LEAs and the overall ratio of major-to-minor amputations. Material and Methods: The study was retrospective and included data from the Romanian National Hospital Discharge Records, conducted between 1 January 2015 and 31 December 2019. Results: The overall number of cases with LEAs was 88,102, out of which 38,590 were aterosclerosis-related LEAs, 40,499 were diabetes-related LEAs, and 9013 were trauma-related LEAs, with an ascending trend observed annually for each of these categories. Of the total non-traumatic amputations, 51.2% were in patients with diabetes. Most LEAs were in men. The total incidence increased from 80.61/100,000 in 2015 to 98.15/100,000 in 2019. Conclusions: Our study reported a 21% increase in total LEAs, 22.01% in non-traumatic LEAs, and 19.65% in trauma-related amputation. The minor-to-major amputation ratio increased over the study period in patients with diabetes. According to these findings, it is estimated that currently, in Romania, there is one diabetes-related amputation every hour and one non-traumatic amputation every 30 min.

Cardiac autonomic neuropathy as risk factor of diabetic complications progression

Introduction. Diabetes mellitus (DM) is the most common and incapacitating endocrine disorder. Diabetic foot syndrome (DFS) is one of the most serious complications of DM, which is the main cause of nontraumatic lower-extremity amputations. Despite the efforts of the entire medical community, the survival rate of DFS patients with non-healing ulcers and after foot surgery does not exceed 50% over 5 years and is comparable to the survival rates of patients with colorectal cancer.Aim. It has been demonstrated that postsurgical diabetic foot wounds tend to chronization of inflammatory process. The diabetic autonomic neuropathy can be involved in diabetic foot damages. We hypothesized that progression of cardiovascular autonomic neuropathy (CAN) leads to aggressive microvascular complications of diabetes and delay the postsurgical wound healing in diabetic foot patients during 2 years of observation.Materials and methods. We examined 94 outpatients with postsurgical diabetic foot wounds and observation period of two years. The clinical neurological examination and standard cardiovascular autonomic reflex tests with identification of severe/advanced abnormalities were performed at baseline and after 2 years. The progression of CAN was diagnosed in cases of an increase in the amount of cardiovascular autonomic reflex tests by 1 score and more. The unsatisfactory result of wound treatment was detected in patients with wound healing delay and new cases of surgery debridement, foot amputations and Charcot foot during 2 years of observation.Results. The mean duration of diabetes was 10.7 year, HbA1c 8.3%, LDL-Chol 3.3 mmol/l, TG 1.8 mmol/l. The 51.1% patients had been amputated in the level of foot, 48.9% patients had surgery debridement. All patients had CAN, confirmed/severe forms in 57.4% cases. The progression of CAN was found in 22.3% patients, the most of them with functional stage at baseline. The aggressive course of CAN increased the risk of progression of diabetic sensomotor neuropathy (OR = 14.6; 95% CI 3.0–70.5; p = 0.0006), nephropathy (OR = 22.4; 95% CI 3.4–147.4; p = 0.0009) and unsatisfactory result of wound treatment (OR = 40; 95% CI 6.0–268.5; p = 0.0001).Conclusions. The patients with diabetic foot surgery wounds has high risk of confirmed/severe CAN and its progression during 2 years. The aggressive course of CAN associates with unsatisfactory result of wound treatment and progression of microvascular diabetic complications.

Diabetic foot disease and the risk of major clinical outcomes

AimsData on the long-term consequences of diabetic foot disease (DFD) are scarce. We examined the association between DFD and major clinical outcomes in patients with diabetes in the general population. MethodsWe conducted a prospective cohort analysis of 1,428 participants with diabetes in the Atherosclerosis Risk in Communities Study. DFD and four clinical outcomes (nontraumatic lower-extremity amputation, cardiovascular disease, major fall, and death) were captured through 2018 using administrative data. We used Cox regression models to evaluate the association between incident DFD (modeled as a time-varying exposure) and the subsequent risk of clinical outcomes. ResultsDuring over two decades of follow-up (1996–1998 to 2018), the cumulative incidence of DFD was 33.3%. Risk factors for DFD included older age, poor glycemic control, long diabetes duration, and prevalent vascular disease (chronic kidney disease, retinopathy, cardiovascular disease). Following incident DFD, the five-year cumulative incidence of major clinical outcomes was 38.9% for mortality, 25.2% for cardiovascular disease, 14.5% for nontraumatic lower-extremity amputation, and 13.2% for major fall. DFD remained associated with all four clinical outcomes after multivariable adjustment, with hazard ratios ranging from 1.5 (cardiovascular disease) to 34.7 (lower-extremity amputation). ConclusionsDFD is common and confers substantial risk for major morbidity and mortality.

The Diabetic Foot-Pain-Depression Cycle.

More than 86,000 Americans with type 2 diabetes mellitus (T2DM) undergo nontraumatic lower-extremity amputations annually. The opioid-prescribing practice of podiatric surgeons remains understudied. We hypothesized that patients with T2DM who undergo any forefoot amputation while using antidepressant medication will have reduced odds of using opioids beyond 7 days. We completed a retrospective cohort study examining patients with T2DM who underwent forefoot amputation (toe, ray, transmetatarsal). Data were restricted to patients with a hemoglobin A1c level less than 8.0% and an ankle-brachial index greater than 0.8. The outcome was use of postoperative opioids beyond 7 days. Patients received an initial opioid prescription of 7 days or less. We developed simple logistic regression models to identify the odds of a patient using opioids beyond 7 days by patient variables: age, race, sex, amputation level, body mass index, antidepressant medication use, and marital status. Variables with P < .1 in the univariate analysis were included in the multiple logistic regression model. Fifty patients met the inclusion criteria. Antidepressant use and marital status were the only statistically significant variables. Adjusting for marital status, patients with antidepressant use had decreased odds (odds ratio, 0.018; 95% confidence interval, 0.001-0.229; P = .002) of using opioids beyond 7 days after a diabetic forefoot amputation. Patients with T2DM who used antidepressants had significantly reduced odds of using opioids beyond 1 week after forefoot amputations compared with those without antidepressant use. We proposed an underlying diabetic foot-pain-depression cycle. To break the cycle, podiatric surgeons should screen this population for depression preoperatively and postoperatively and not hesitate to make a mental health referral if warranted. Nontraumatic amputations can be a traumatic experience for patients; psychiatrists and other mental health providers should be members of limb preservation teams.

D13. A Randomized Controlled Trial Evaluating the Outcomes for Closed Incision Negative Pressure Wound Therapy for Non-traumatic Lower Extremity Amputations: A Pilot Study

PURPOSE: Peripheral artery disease (PAD) can have detrimental impacts on wound healing. Negative pressure wound therapy (NPWT) has demonstrated effectiveness for open wounds, but its effectiveness on closed wounds remains unclear. The study aim was to compare the rate of wound complications when using NPWT on post-amputation closed incisions versus standard dry dressing. METHODS: Patients were randomized into two cohorts of postoperative closed incisional dressing. Cohort A received the standard dry dressing. Group B received Foam, Drape, and PrevenaTM. The device was placed over the closed incision, with negative pressure set to 125mmHG. Wound complications were assessed at 5-days, 30-days, and 90-days postoperative. RESULTS: Of the 108 patients enrolled, 47 patients (43.5%) did not complete the study. Data was analyzed for the remaining 30 patients who received dry dressing and 31 in the NPWT group. There were no demographic differences between cohorts. The dry dressing group had significantly higher rates of ESRD (40% vs. 12.9%), PAD (66.7% vs. 19.4%), PVD (60% vs. 19.4%), and CAD (26.7% vs. 6.5%). Amputation type was similar between groups. No difference in rates of wound complications was observed between the PrevenaTM and dry dressing groups at all postoperative time points. CONCLUSION: Overall, our data suggests that novel NPWT placement on closed incisions post-amputation does not significantly reduce wound complications when compared to standard of care.

The Frequency of Major and Minor Amputations in Patients with Diabetic Foot

Introduction: Diabetic foot (DF) is the main cause of non-traumatic lower extremity amputations. Major and minor amputations in diabetic foot disease are benchmark indicators of natural history and prognosis of disease. This study will help to prevent DF complications and improve care of diabetes foot. Objectives: To determine the frequency of major and minor amputations and the factors responsible for patients with diabetic foot coming in surgical OPD. Methods: All the patients who presented in hospital with diabetic foot ulcer were included in this study from 01-11-2019 to 30-10-2020. One hundred and forty patients of either gender with age between 20 to 80 years with diabetic foot ulcers of any grade were enrolled in the study. Frequency of minor and major amputations was measured. Results: Out of three hundred and twenty patients, 16.4% (n=69/320) patients underwent lower limb amputations. Minor amputations were made in 12.1% (n=51/320) and major were made in 4.3% (n=18) of patients. Frequency of amputations was significantly higher in older age groups (61-80 years), patients with longer disease duration (&gt;10 years), with poor glycemic control (HBA1-C&gt;8.0) and patients with higher grades of ulcers (grades III and IV) (P&lt;0.05). No significant difference was observed among gender, different education and occupation groups (P&gt;0.05). Conclusions: A significant percentage of patients with diabetic foot ulcers underwent lower limb amputations, which was significantly associated with older age, longer disease duration, poor glycemic control and higher grades of ulcers. Keywords: Diabetic foot, Lower limb amputation, diabetic ulcers.

Comparison of Microbiological Results of Superficial Swab versus Deep Tissue Biopsy in Diabetic Foot Infections: A Prospective Observational Study from North India

Introduction: Diabetes mellitus is the leading cause of nontraumatic lower extremity amputation worldwide. Risk of developing a foot ulcer in diabetic patients has increased to 12-25% during their lifetime. Inappropriate sampling technique leading to contaminated samples is a well-known threat among patients of diabetic foot. In this study we compared two microbiological sampling techniques, superficial swabbing and deep tissue biopsy for identification of pathogens. Material and Methods: It was a prospective observational cross-sectional study. Diabetic foot was defined as per standard guidelines. Careful and meticulous examination of diabetic foot ulcer was done. Two specimens were collected from each wound. The first specimen was a wound swab collected by using Levine technique; another was taken via punch biopsy from the ulcer base. It was a deep tissue sample of 4 mm size. Results: A total of 120 diabetic patients with diabetic foot infection were included in this study. In swab culture 80.83% patients had mono microbial growth, 15% had polymicrobial and 4.10% had no growth. In deep tissue culture 87.50% had mono microbial growth, 2.50% had poly microbial and 10% were sterile. Staphylococcus aureus was most common isolate followed by E. coli. It was observed that though monomicrobial growth was most common in both the types of samples but was higher in deep tissue biopsy than in superficial swab samples. Conclusion: The isolation of microorganism via deep tissue sampling in diabetic foot ulcer patients is more reliable compared to superficial swab samples and a better guide to antibiotic therapy.