Noting the recent literature and the potentially elevated risk for COVID-19 related complications for patients with diabetes in the hospital setting, this author says triaging of emergent patients with DFUs on an outpatient basis may be a viable path moving forward.
By Adam L. Isaac, DPM, FACFAS
As diabetes complications involving the foot and lower extremity continue to rise at an alarming rate, the management and treatment of diabetic foot ulcers (DFUs), diabetic foot infections (DFIs) and lower extremity amputations (LEAs) place a significant burden on providers, patients and their caretakers, and health-care systems throughout the world. In the United States, lower extremity care accounts for one-third of the annual direct costs for diabetes.1-5 According to the latest data, the five-year mortality rate following a major lower extremity amputation (56.6 percent) is second only to lung cancer (80 percent).1-5 Furthermore, based on criteria set by the World Health Organization, lower extremity complications of diabetes now constitute a top ten global burden of disability.6,7
Moreover, previous research revealed that the lifetime risk of patients with diabetes developing a foot ulcer is 34 percent and greater than 50 percent of these wounds become infected.1,8 In fact, the most common diabetes-related complication leading to hospitalization and lower limb amputation is diabetic foot infection.9-11 It has been reported that someone develops a DFU every 1.2 seconds, someone dies from diabetes every seven seconds and amputation reportedly occurs every 20 seconds.12
Perhaps at no other time in history have the devastating consequences of diabetes become more apparent than during the current COVID-19 global pandemic. Beyond specific COVID-19-related complications, a recent report in The New York Times found that at least 356,000 more people in the United States have died than would have in a normal year since the onset of the pandemic, but not all of these deaths are directly linked to COVID-19.13 The Centers for Disease Control and Prevention (CDC) National Center for Health Statistics states that, “excess deaths are typically defined as the difference between the observed numbers of deaths in specific time periods and expected numbers of deaths in the same time periods.”14 Based on data from the New York Times article, deaths from diabetes during the pandemic are 15 percent above normal (March to November 2020) and attributed in part to economic stress and challenges faced by families across the country.13
In terms of diabetes-related lower extremity complications, Casciato and colleagues recently noted an increase in the number of Infectious Diseases Society of America (IDSA) severe DFIs in emergent presentations and amputations performed at a level one trauma center in Ohio during the pandemic. In fact, according to the authors, the odds of undergoing any level of amputation were 10.8 times higher during the pandemic while the risk of major amputations increased with an odds ratio of 12.5.15 An accompanying editorial in the Journal of the American Podiatric Medical Association (JAPMA) by Rogers and colleagues notes that “increased awareness, proper prioritization, and efficiencies of care in lower risk settings are the first steps in mitigating this parallel pandemic of diabetes-related amputations.”16
Rethinking The Paradigm On Outpatient Care Of Diabetic Foot Complications
Therefore, the appropriate and timely management of DFUs in the outpatient setting is a critical component of any successful limb preservation program. Yet, in light of the ongoing COVID-19 global pandemic, a paradigm shift is necessary in terms of how we triage these patients and we must make a clear distinction between “urgent” and “emergent.”
Rogers and colleagues were among the first to propose a change in the delivery of outpatient wound care during the pandemic by introducing the “Pandemic Diabetic Foot Triage System.”17 The system intends to provide guidance for wound providers during the pandemic by reducing “the burden on the healthcare system by keeping diabetic foot and wound patients safe, functional, and at home.” Furthermore, with this system, Rogers and coworkers recommend a shift away from hospital-based care to increased use of telemedicine and remote patient monitoring, and more in-home visits.17
Given that patients with DFU often present with multiple comorbidities, they are at risk for developing severe COVID-19 complications. Therefore, providers must focus on mitigating potential virus exposure, thereby reducing the risk of developing severe complications. Again, in the pandemic era, providers must be willing and able to adapt their care based on the safety needs of the patient and greater public.
The “Wound Center Without Walls” strategy proposes a separation of the importance of the physical location (i.e. hospital-based wound center) while aggressively triaging and providing care to patients in a community-centered and technology-forward approach.18 In the previous “Pre-Pandemic Model of Wound Care,” Rogers and colleagues maintain the goal for wound care was “healing at all costs” but in the current model, prevention of hospitalization and reduced resource utilization are paramount. More specifically, in the “Pandemic Model of Wound Care,” one should treat those with less severe DFIs on an outpatient basis with a greater tolerance for ischemia, reserving the hospital only for some IDSA moderate DFIs (including osteomyelitis), severe DFIs, gas gangrene, systemic inflammatory response syndrome (SIRS)/ sepsis and acute limb-threatening ischemia.18
In 2020, Bekeny and coworkers at the MedStar Georgetown University Hospital in Washington, D.C. reported an increase in the number of remote telemedicine visits for wound patients during the pandemic while reserving in-person appointments for the most urgent cases.19 These authors describe an initial triage phase in which all patients with wounds are evaluated remotely in order to determine if there is a need for in-person management. Advances in technology permit the use of remote wound measurements and photos for accurate and reliable management, and there has been decreased volume of in-office personnel with increased time between patient appointments in order to decrease potential COVID-19 virus exposure for staff and patients.19
As more time passes and data becomes available, it will be critical to reassess the timing of diabetic foot management, including DFUs, in the post-pandemic era. While this in no way should imply the lack of importance or urgency in treating diabetic foot complications, the current pandemic has changed, and will forever change, the way in which we manage our patients with an emphasis on keeping at-risk patients out of harm’s way. Of course, the “urgent” side of the argument is certainly valid and every diabetic foot ulcer has the potential to progress and deteriorate rapidly. If we have learned anything over the past year or so, it is that we must adapt and cope with events on the ground.
Dr. Isaac is the Director of Research with Foot & Ankle Specialists of the Mid-Atlantic (FASMA). He is a Diplomate of the American Board of Foot and Ankle Surgery.
While acknowledging the pandemic-related restrictions on the treatment of patients with diabetic foot ulcers, this author says timely assessment and management remain essential in this high-risk population in order to prevent secondary infections and amputations.
By Brian D. Lepow, DPM
Clinical treatment of the diabetic foot is even more of an emergent matter given the current state of our health-care environment due to the COVID-19 pandemic. Newly implemented regulations, social distancing, self-quarantining and community shutdowns have forced us to rethink how we function and take care of our patients. In response to the pandemic, some hospitals closed clinics and wound care programs, either because they misclassified those services as nonessential or due to limits on visitors and outpatients entering the premises.1,2
Chronic wounds are a prevalent concern and costly to the health-care system.2,3 In a large retrospective study of Medicare beneficiaries, nearly 15 percent had a chronic wound or infection during the course of one year.2 With chronic diabetic foot ulcers (DFUs) already occupying a major part of the health-care system, complete cessation of professional wound care during these restricted times may only exacerbate these wounds, resulting in irreversible damage, more severe complications or possibly even mortality.4 The World Health Organization in May 2020 surveyed 155 countries and found that half of them partially or completely disrupted services for diabetes and diabetes-related complications, and warned of the pandemic’s global impact on non-communicable diseases.5
Untreated chronic DFUs can be an entry point for secondary infections, thus further debilitating patients.4 For those with diabetes, many of whom suffer from a multitude of comorbidities including chronic non-healing wounds, the pandemic has left many without their customary levels of regular care. That places this particular population, like many others suffering from chronic disease, at great risk.
Early in the pandemic, the Alliance of Wound Care Stakeholders advised hospitals, policymakers and governments not to close wound centers or delay necessary care for wound patients because it would result in an increase in infections, hospital admissions, emergency room visits and amputations.1,6 However, out of the need to protect both health-care professionals and patients, outpatient wound care visits for non-urgent conditions were still largely prohibited over the last year.1 The literature also suggests that patients with wounds may even voluntarily refuse to visit clinics for fear of need for quarantine and/or exposure to COVID-19.4
Looking at a comparison of patients admitted to the podiatric service pre-pandemic versus during the COVID-19 pandemic, Rogers and colleagues found that patients with diabetes were more likely to present with Infectious Diseases Society of America (IDSA) severe infections and more likely to present in an emergent manner.6 Patients with diabetes were 10.8 times more likely to undergo any level of amputation and 12.5 times more likely to have a major amputation (transfemoral or transtibial) during the pandemic.6
In “Wound Center Without Walls: The New Model of Providing Care During the COVID-19 Pandemic,” Rogers and colleagues highlight a new shift in wound care toward triaging patients, evaluations, procedures, treatments and follow-up.2 As these authors note, “The pre-pandemic goal for most patients with wounds was healing at any cost.”2 The primary points of emphasis were the likelihood of healing and the speed of that healing. Now these goals have shifted as has the site of wound care, which subsequently may reduce access to certain pre-pandemic practices and protocols. Now the focus has become prevention of these serious complications and avoiding hospitalization.
Prior to the pandemic, most patients presented weekly or biweekly for regular wound care services. As the lockdown took hold, most outpatient wound care centers and clinics had to shut down, leaving an entire population in peril, wondering when they could once again see their physicians. Some centers rushed to implement telehealth visits that have become the lifeline for clinical assessment as the pandemic took a tighter hold on our society. However, those virtual visits were no replacement for in-person clinical evaluations.
As lockdowns started to lift in various cities, the need for evaluation and treatment of those at-risk patients in person and in a more emergent manner steadily
grew. In this current state, wound care visits in the outpatient setting are more of an emergent matter than urgent as these patients have had no choice but to stay home and stay safe over these last few months.
Timely and effective wound assessment and management is critical for success and the ultimate healing trajectory. In my observation, wounds that have routine debridement (every one to two weeks) tend to heal quicker than those debrided less often. With this shift in care due to the COVID-19 pandemic, we must consider a reconfiguration of clinical space in order to accommodate a sicker patient population. It is important to remember that the primary goal is to continue to provide high-quality care while reducing utilization of hospital services.2
In conclusion, we have to realize that these pandemic medicine protocols will last for at least the next 18 months.7 Outpatient clinics need to prepare to address a sicker patient presentation and be ready to perform more aggressive debridement and even minor amputations in the outpatient clinical setting in order to temporize infection and prevent further tissue loss. Physicians in outpatient clinics that take care of this population will have to adapt, just like the rest of our environment, to this new normal to help minimize exposure and risk by keeping this vulnerable patient population out of hospitals and out of harm’s way.
Dr. Lepow is an Assistant Professor of Surgery in the Division of Vascular Surgery and Endovascular Therapy at Baylor College of Medicine in Houston, Texas. He is a Diplomate of the American Board of Podiatric Medicine and is a part of an academic practice dedicated toward limb preservation.
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3. American Diabetes Association. Economic costs of diabetes in the US in 2012. Diabetes Care. 2013;36(4):1033–1046.
4. Armstrong DG, Swerdlow MA, Armstrong AA, Conte MS, Padula WV, Bus SA. Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer. J Foot Ankle Res. 2020;13(1):1-4.
5. Barshes NR, Sigireddi M, Wrobel JS, et al. The system of care for the diabetic foot: objectives, outcomes, and opportunities. Diabet Foot Ankle. 2013;4(1):21847.
6. Zhang Y, Lazzarini PA, McPhail SM, van Netten JJ, Armstrong DG, Pacella RE. Global disability burdens of diabetes-related lower-extremity complications in 1990 and 2016. Diabetes Care. 2020;43(5):964-974.
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10. Ndosi M, Wright‐Hughes A, Brown S, et al. Prognosis of the infected diabetic foot ulcer: A 12‐month prospective observational study. Diabet Med. 2018;35(1):78-88.
11. Lavery LA. Discussion: Off-loading the diabetic foot for ulcer prevention and healing. Plast Reconstr Surg. 2011;127 Suppl 1:257S- 258S.
12. Armstrong DG, Kanda VA, Lavery LA, Marston W, Mills JL, Boulton AJ. Mind the gap: Disparity between research funding and costs of care for diabetic foot ulcers. Diabetes Care. 2013;36(7):1815-1817.
13. Lu D. 2020 was especially deadly. COVID wasn’t the only culprit. The New York Times. Available at: https://www.nytimes.com/ interactive/2020/12/13/us/deaths-covid-other-causes.html . Published December 13, 2020. Accessed February 4, 2021.
14 Centers for Disease Control and Prevention. Excess deaths associated with COVID-19. Available at: https://www.cdc.gov/nchs/ nvss/vsrr/covid19/excess_deaths.htm . Updated February 10, 2021. Accessed February 16, 2021.
15. Casciato DJ, Yancovitz S, Thompson J, et al. Diabetes-related major and minor amputation risk increased during the COVID-19 pandemic. J Am Podiatr Med Assoc. 2020;20- 224. Doi: 10.7547/20-224 . Online ahead of print.
16. Rogers LC, Snyder RJ, Joseph WS. Diabetes-related amputations: a pandemic within a pandemic. J Am Podiatr Med Assoc. 2020;20- 248. Doi: 10.7547/20-248 .
17. Rogers LC, Lavery LA, Joseph WS, Armstrong DG. All feet on deck—the role of podiatry during the COVID-19 pandemic: preventing hospitalizations in an overburdened healthcare system, reducing amputation and death in people with diabetes. J Am Podiatr Med Assoc. 2020. Doi: 10.7547/20- 051 . Online ahead of print.
18. Rogers LC, Armstrong DG, Capotorto J, et al. Wound center without walls: the new model of providing care during the COVID-19 pandemic. Wounds. 2020;32(7):178- 185.
19. Bekeny JC, Zolper EG, Steinberg JS, et al. Ensuring quality care in the COVID-19 era: applying the Donabedian model to tertiary wound care center practices. J Am Podiatr Med Assoc. 2020;20-080. Doi: 10.7547/20- 080 . Online ahead of print.
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2. Rogers LC, Armstrong DG, Capotorto J, et al. Wound center without walls: the new model of providing care during the COVID-19 pandemic. Wounds. 2020;32(7):178- 185.
3. Martinengo L, Olsson M, Bajpai R, et al. Prevalence of chronic wounds in the general population: systematic review and meta-analysis of observational studies. Ann Epidemiol. 2019;29:8-15.
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5. World Health Organization. COVID-19 significantly impacts health services for noncommunicable diseases. Available at: https:// www.who.int/news/item/01-06-2020-covid-19-significantly-impacts-health-services-for-noncommunicable-diseases . Published June 1, 2020. Accessed February 9, 2021.
6. Rogers LC, Snyder RJ, Joseph WS. Diabetes-related amputations: a pandemic within a pandemic. J Am Podiatr Med Assoc. Available at: https://doi.org/10.7547/20-248 . Published November 3, 2020. Accessed February 5, 2021.
7. Rogers L. How podiatrists can navigate the shifting model of wound care during the COVID-19 pandemic. Podiatry Today. Available at: https://www.podiatrytoday.com/ blogged/how-podiatrists-can-navigate-shifting-model-wound-care-during-covid- 19-pandemic . Published April 2, 2020. Accessed February 9, 2021.