A review of disparities in peripheral artery disease and diabetes-related amputations during the COVID-19 pandemic.

The COVID-19 pandemic has profoundly affected health care delivery. In addition to the significant morbidity and mortality associated with acute illness from COVID-19, the indirect impact has been far-reaching, including substantial disruptions in chronic disease care. As a result of pandemic disruptions in health care, vulnerable and minority populations have faced health inequalities. The aim of this review was to investigate how the COVID-19 pandemic has impacted vulnerable populations with limb-threatening peripheral artery disease and diabetic foot infections.

Hospitalisation rate and mortality among people with and without diabetes during the COVID-19 pandemic year 2020.

Most studies reported reduced health care use among people with diabetes during the COVID-19 pandemic. This may be due to restricted medical services or people avoiding health care services because they fear being infected with COVID-19 in health care facilities. The aim of our study was to analyse hospitalisation and mortality in people with and without diabetes in Germany during the COVID-19 pandemic year 2020 compared to 2017-2019. The data were sourced from a German statutory health insurance company covering 3.2 million people. We estimated age-sex standardised rates of mortality, all-cause hospitalisation, hospitalisation due to coronary heart disease (CHD), acute myocardial infarction (AMI), stroke, diabetic foot syndrome (DFS), and major and minor amputations in people with and without diabetes. We predicted rates for 2020 using Poisson regression based on results from 2017-2019 and compared these with the observed rates.In people with diabetes, the hospitalisation rate for major amputation was significantly increased, while all-cause hospitalisation rate and hospitalisation due to CHD, AMI and DFS were significantly decreased compared to the previous period. Moreover, we found a significantly increased mortality and hospitalisation rate for minor amputation in people without diabetes while all-cause hospitalisation and hospitalisation due to CHD and AMI was significantly lower during the COVID-19 pandemic year 2020.We observed changes in health care utilisation and outcomes during the COVID-19 pandemic compared to previous years in people with and without diabetes. Concerning diabetes care, the increase of hospitalisations due to amputation in people with diabetes with a simultaneous reduction in DFS needs special attention.

Characteristics of Diabetic Foot Ulcer Patients Pre- and During COVID-19 Pandemic: Lessons Learnt From a National Referral Hospital in Indonesia.

BACKGROUND: Diabetic foot ulcer (DFU) is one of the most terrifying diabetic complications for patients, due to the high mortality rate and risk for amputation. During the COVID-19 pandemic, many diabetic patients limited their visits to the hospital, resulting in delays for treatment especially in emergency cases. OBJECTIVE: This study aimed to compare the characteristics of patients with DFU pre- and during COVID-19 pandemic period. Methods: This study was a retrospective cohort study using foot registry data. We compared our patients' characteristics pre-COVID-19 pandemic period (1 March 2019-28 February 2020) and during COVID-19 pandemic period (1 March 2020-28 February 2021). RESULTS: Cohorts of 84 and 71 patients with DFU pre- and during COVID-19 pandemic period, respectively, were included in this study. High infection grade (66.7% vs 83.1%, P = .032), osteomyelitis event (72.6% vs 87.3%, P = .04), leukocyte count (15 565.0/µL vs 20 280.0/µL, P = .002), neutrophil-to-lymphocyte ratio (7.7 vs 12.1, P = .008), waiting time-to-surgery (39.0 h vs 78.5 h, P = .034), and number of major amputation (20.2% vs 39.4%, P = .014) were significantly higher during the COVID-19 pandemic period. CONCLUSION: During the COVID-19 pandemic, patients with DFU had more severe infection, higher proportion of osteomyelitis, longer waiting time for getting surgical intervention, and higher incidence of major amputation.

A Population-Based Analysis of Diabetes-Related Care Measures, Foot Complications, and Amputation During the COVID-19 Pandemic in Ontario, Canada.

Importance: Deferred diabetic foot screening and delays in timely care of acute foot complications during the COVID-19 pandemic may have contributed to an increase in limb loss. Objective: To evaluate the association of the COVID-19 pandemic with diabetes-related care measures, foot complications, and amputation. Design, Setting, and Participants: This population-based cohort study included all adult residents of Ontario, Canada, with diabetes and compared the rates of selected outcomes from January 1, 2020, to February 23, 2021, vs January 1, 2019, to February 23, 2020. Main Outcomes and Measures: Comprehensive in-person diabetes care assessment, including foot examination; hemoglobin A1c (HbA1c) measurement; emergency department visit or hospitalization for diabetic foot ulceration, osteomyelitis, or gangrene; lower extremity open or endovascular revascularization; minor (toe or partial-foot) amputation; and major (above-ankle) leg amputation. Rates and rate ratios (RRs) comparing 2020-2021 vs 2019-2020 for each measure were calculated for 10-week periods, anchored relative to onset of the pandemic on March 11, 2020 (11th week of 2020). Results: On March 11, 2020, the study included 1 488 605 adults with diabetes (median [IQR] age, 65 [55-74] years; 776 665 [52.2%] men), and on March 11, 2019, the study included 1 441 029 adults with diabetes (median [IQR] age, 65 [55-74] years; 751 459 [52.1%] men). After the onset of the pandemic, rates of major amputation in 2020-2021 decreased compared with 2019-2020 levels. The RR for the prepandemic period from January 1 to March 10 was 1.05 (95% CI, 0.88-1.25), with RRs in the pandemic periods ranging from 0.86 (95% CI, 0.72-1.03) in May 20 to July 28 to 0.95 (95% CI, 0.80-1.13) in October 7 to December 15. There were no consistent differences in demographic characteristics or comorbidities of patients undergoing amputation in the 2020-2021 vs 2019-2020 periods. Rates of comprehensive in-person diabetes care assessment and HbA1c measurement declined sharply and remained below 2019-2020 levels (eg, in-person assessment, March 11 to May 19: RR, 0.28; 95% CI, 0.28-0.28). The rates of emergency department visits (eg, March 11 to May 19: RR, 0.67; 95% CI, 0.61-0.75), hospitalization (eg, March 11 to May 19: RR, 0.77; 95% CI, 0.68-0.87), open revascularization (eg, March 11 to May 19: RR, 0.66; 95% CI, 0.56-0.79), endovascular revascularization (March 11 to May 19: RR, 0.70; 95% CI, 0.61-0.81), and minor amputation (March 11 to May 19: RR, 0.70; 95% CI, 0.60-0.83) initially dropped but recovered to 2019-2020 levels over the study period. Conclusions and Relevance: In this population-based cohort study, disruptions in care related to the COVID-19 pandemic were not associated with excess leg amputations among people living with diabetes. As the pandemic ends, improved prevention and treatment of diabetic foot complications will be necessary to maintain these positive results.

Fetal bovine acellular dermal matrix for the closure of diabetic foot ulcers: a prospective randomised controlled trial.

AIM: The purpose of this clinical trial was to evaluate the safety and efficacy of a fetal bovine acellular dermal matrix (FBADM) plus standard of care (SOC) for treating hard-to-heal diabetic foot ulcers (DFUs). METHOD: A prospective, multi-centre, randomised controlled trial was carried out. The study included a 2-week run-in period, a 12-week treatment phase and a 4-week follow-up phase. The primary endpoint was complete wound closure at 12 weeks. RESULTS: Twenty-one US sites enrolled and randomised 226 patients with hard-to-heal DFUs. The study was terminated early due to the COVID-19 pandemic, which led to a modified intent-to-treat (mITT) population of 207 patients, with 103 in the FBADM group and 104 in the SOC group. Of these participants, 161 completed the study per protocol (mPP population), with 79 receiving FBADM, and 82 without. At the first analysis point, patients treated with FBADM were found to be significantly more likely to achieve complete wound closure compared with SOC alone (mITT: 45.6% versus 27.9% p=0.008; mPP: 59.5% versus 35.6% p=0.002). The difference in outcome yielded an odds ratio of 2.2 (95% confidence interval (CI): 1.2, 3.9; p=0.008). Median time to closure within 12 weeks was 43 days for the FBADM group compared to 57 days for the SOC group (p=0.36). The median number of applications of FBADM to achieve closure was one. Adverse events were similar between groups and no product-related serious adverse events occurred. CONCLUSIONS: These results indicate that in many cases a single application of FBADM in conjunction with SOC offers a safe, faster and more effective treatment of DFUs than SOC alone.

Hospital admission for type 2 diabetes mellitus under the Universal Coverage Scheme in Thailand: A time- and geographical-trend analysis, 2009-2016.

BACKGROUND: Descriptive analyses of 2009-2016 were performed using the data of the Universal Coverage Scheme (UCS) which covers nearly 70 percent of the Thai population. The analyses described the time and geographical trends of nationwide admission rates of type 2 diabetes mellitus (T2DM) and its complications, including chronic kidney disease (CKD), myocardial infarction, cerebrovascular diseases, retinopathy, cataract, and diabetic foot amputation. METHODS AND FINDINGS: The database of T2DM patients aged 15-100 years who were admitted between 2009 and 2016 under the UCS and that of the UCS population were retrieved for the analyses. The admitted cases of T2DM were extracted from the database using disease codes of principal and secondary diagnoses defined by the International Classification of Diseases 9th and 10th Revisions. The T2DM admission rates in 2009-2016 were the number of admissions divided by the number of the UCS population. The standardized admission rates (SARs)were further estimated in contrast to the expected number of admissions considering age and sex composition of the UCS population in each region. A linearly increased trend was found in T2DM admission rates from 2009 to 2016. Female admission rates were persistently higher than that of males. In 2016, an increase in the T2DM admission rates was observed among the older ages relative to that in 2009. Although the SARs of T2DM were generally higher in Bangkok and central regions in 2009, except that with CKD and foot amputation which had higher trends in northeastern regions, the geographical inequalities were fairly reduced by 2016. CONCLUSION: Admission rates of T2DM and its major complications increased in Thailand from 2009 to 2016. Although the overall geographical inequalities in the SARs of T2DM were reduced in the country, further efforts are required to improve the health system and policies focusing on risk factors and regions to manage the increasing T2DM.

Impact of COVID-19 Pandemic on the Outcomes in Patients With Critical Limb Threatening Ischaemia and Diabetic Foot Infection.

OBJECTIVE: Examine the impact of COVID-19 pandemic on the outcomes in patients with CLTI or DFI. BACKGROUND: Patients with CLTI and/or DFI are at risk of amputations if not treated in a timely manner. METHODS: We compared the outcomes in patients with CLTI or DFI during 2 periods; Period 1[P1] (15/03/2019-31/05/2019) and period 2[P2] (15/03/ 2020-31/05/2020- corresponding to COVID-19 pandemic). RESULTS: One hundred thirty-nine patients were treated in P1 [mean age 70 years (±11), Male:Female = 102:37] whereas 95 patients were treated in P2 [mean age 67 (±12), Male:Female = 64:31]. The 2 cohorts were matched regarding Rutherford category (P = 0.25) and GLASS classification (P = 0.38). Notably, the time from onset of symptom to clinical presentation was significantly longer [31 (1-105) days vs 27 (0-78) days, (P = 0.017)], whereas the time from presentation to first intervention was significantly shorter [3 (0-61) days vs 5 (0-65) days, (P = 0.013)] in P2 compared to P1. There was a significantly higher white cell count (P = 0.014) and CRP (P = 0.004) on admission in P2. Having treatment for CLTI or DFI in P2 was an independent predictor of worse primary patency rate and freedom from major adverse limb events. At 90 days, amputation-free survival and limb salvage were noticeably worse in P2 compared to P1 (amputation-free survival was 80% and 87% whereas limb salvage was 64% and 72% in P2 and P1, respectively). CONCLUSIONS: Patients with CLTI and DFI experienced a significantly delayed presentation with features of sepsis on admission in P2. Treatment in P2 was a predictor of worse primary patency and freedom from major adverse limb events and therefore close and long follow-up is advisable.

Challenges in diabetic foot treatment during pandemic of COVID-19.

OBJECTIVES: To avoid hospital spread of Coronavirus-2019 (COVID-19) and to analyze out of hospital outcomes after amputation. METHODS: Prospective analysis of data obtained from 60 diabetic patients in 2020 was performed at Cantonal Hospital Zenica, Zenica, Bosnia and Herzegovina. Personal protection equipment included double surgical mask, glasses, disposable surgical coats, and surgical masks for patients. Swabs were used to take samples from wounds. We randomly divided patients in 2 groups of 30 patients each. In pre-operative treatment, we used local anesthesia lidocaine hydrochloride 2% (Belupo, Koprivnica, Croatia) in group A and systemic analgesia intravenous tramadol chloride 100 mg intravenous (Krka, Novo Mesto, Slovenia) in group B. Wounds were surgically treated each day and heal spontaneously. Periodical control exams were performed. RESULTS: Wound healing did not present any statistically significant differences between groups (group A: 69±21.97 and B: 61±22.13 days, t=-1.22; p=0.11). No statistically significant differences (p<0.05) between groups A and B in wound healing regarding to gender or cigarette use was noted. CONCLUSION: No significant differences in amputation treatment between the 2 comparative groups were noted. No confirmed COVID-19 infections in medical staff who performed surgical interventions or in treated patients were detected.

Impact of the coronavirus disease 2019 pandemic on an academic vascular practice and a multidisciplinary limb preservation program.

With the aggressive resource conservation necessary to face the coronavirus disease 2019 pandemic, vascular surgeons have faced unique challenges in managing the health of their high-risk patients. An early analysis of patient outcomes after pandemic-related practice changes suggested that patients with chronic limb threatening ischemia have been presenting with more severe foot infections and are more likely to require major limb amputation compared with 6 months previously. As our society and health care system adapt to the new changes required in the post-coronavirus disease 2019 era, it is critical that we pay special attention to the most vulnerable subsets of patients with vascular disease, particularly those with chronic limb threatening ischemia and limited access to care.