DIABETES AND THE AT-RISK LOWER LIMB: Shawn M. Cazzell Disclosure of Commercial Support: Dr. Shawn Cazzell reports the following financial relationships: Speakers Bureau: Organogenesis Grants/Research Support: Medical Advisory Board-Wound Care Advantage Corporation: Limb Preservation Platform, Co-Founder-Health Stratification Group, Co-Founder-CR Wound Solutions 1
An Epidemic of Diabetes There is a strong correlation between people who suffer from obesity and people who develop type 2 diabetes Consequently, as the obesity epidemic has grown in recent years, the incidence of type 2 diabetes has also increased across populations In 2010, there were approximately 26 million people in the U.S. with diabetes Nearly 7 million of those were undiagnosed 26.9% of U.S. residents, aged 65 and older, have diabetes ~1.9 million people, aged 20 or older were newly diagnosed National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011. Available at http://www.cdc.gov/diabetes/pubs/pdf/ ndfs_2011.pdf. Accessed 12 November 2012. Obesity Trends* Among US Adults, BRFSS 1985 BRFSS = Behavioral Risk Factor Surveillance System. Obesity Trends Among US Adults between 1985 and 2010. BRFSS, Centers for Disease Control website. Available at http://www.cdc.gov/obesity/downloads/obesity_trends_2010.ppt. Accessed 12 November 2012. No Data < 10% 10% 14% 2
Obesity Trends* Among U.S. Adults, BRFSS 2010 No Data < 10% 10% 14% 15% 19% 20% 24% 25% 29% 30% BRFSS = Behavioral Risk Factor Surveillance System. Obesity Trends Among U.S. Adults between 1985 and 2010. BRFSS, Centers for Disease Control website. Available at http://www.cdc.gov/obesity/downloads/obesity_trends_2010.ppt. Accessed 22 January 2013. The Global Epidemic of Diabetes By 2030, the number of people with diabetes globally will rise to an estimated 552 MILLION The International Diabetes Foundation, IDF Diabetes Atlas, 5th ed.: http://www.idf.org/diabetesatlas/5e/the-global-burden. Accessed 12 November 2012. 6 3
Diabetes Mellitus Overview In 2010, diabetes mellitus affected 25.8 million people in the US and is projected to affect more than 12% of the population by the year 2050 In 2007, diabetes was the 7 th leading cause of death in the US, causing more than 71,000 deaths 7 Diabetic Foot Ulcers (DFUs) Diabetic foot ulcers (DFUs) are one of the most common complications of diabetes The annual incidence for DFUs in individuals with diabetes is approximately 3.4% 1,2 The lifetime incidence of a DFU in patients with diabetes may be as high as 25% 3,4 15-20% of diabetic foot ulcers result in lower extremity amputation 85% of lower limb amputations in patients with diabetes are proceeded by ulceration Peripheral neuropathy is a major contributing factor in DFUs 1-8 Other factors: foot deformity, trauma, and peripheral vascular disease 1. Lavery LA, et al. Diabetes Care. 2003;26:1435-8. 2. Ramsey SD, et al. Diabetes Care. 1999;22:382-7. 3. Sanders LJ. J Am Podiatry Med Assoc. 1994;84(7):322-8. 4. Singh N, et al. JAMA. 2005;293(2):217-28. 5. Boulton AJM, et al. Lancet. 2005;366:1719-24. 6. Boulton AJM, et al. Diabetes Care. 2008;31(8):1679-85. 7. Armstrong DG, et al. Am Fam Physician. 1998;57(6):1325-32. 8. Reiber GE, et al. Diabetes Care.1999;22:157-62. 8 4
Epidemiology of Diabetic Foot Ulcers Hospitalized diabetic foot ulcer (DFU) patients can expect a 59% longer length of stay than hospitalized diabetic patients without a foot ulcer 3 A lower-extremity amputation (LEA) will be required by 14% to 24% of DFU patients 4 The incidence of LEA in people with diabetes continues to rise despite deliberate efforts to prevent amputations in the last decade 4 1. Palumbo PJ et al. In: Harris MI et al, eds. Diabetes in America: Data compiled 1984. NIH publication No. 85-1468. 2. Frykberg RG. J Foot Ankle Surg. 1998;37:440-446. 3. Reiber GE et al. In: Harris MI et al, eds. Diabetes in America. 2nd ed. NIH Publication No. 95-1468; 1995:409-428. 4. Consensus Development Conference on Diabetic Foot Wound Care. ADA. Diabetes Care. 1999;22:1354-1360. 5-Year Mortality Rates Armstrong et al. Int Wound J. 2007;Dec;4(4):286. CA = Carcinoma. PAD = Peripheral artery disease. 5
Risk Accumulates Over a Lifetime 1 Among all people with diabetes, up to 4% annually will develop a DFU... but 25% will develop a DFU in their lifetime. 1. Singh N, et al. JAMA. 2005;293(2):217-228. Economic Consequences of DFUs Costs to Treat a DFU Over a 2-Year Period Following Detection Inflation adjusted values for 2000 to 2011 medical costs at: http://www.halfhill.com/inflation.html Ramsey SD, et al. Diabetes Care. 1999;22:382-7. 12 6
Diabetes Mellitus: Estimated Costs in the United States 1 Estimated Costs of Diabetes in the United States, 2007 Direct Medical Costs* Diabetes treatment 2 Chronic diabetes-related complications 2 Excess general medical costs 2 Indirect Costs Work loss Disability Premature mortality Total Costs $116 billion* $58 billion $174 billion *After adjustment for population age and sex differences, the average medical expenditures among people with diagnosed diabetes are 2.3 times higher than expenditures among people without diabetes. 1. Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011 2. American Diabetes Association. Economic Costs of Diabetes in the United States in 2007. Diabetes Care 2008;31:596 615. DFUs Are A Serious Health Issue 1 Peripheral vascular disease and peripheral neuropathy are risk factors for diabetic foot ulcers (DFUs) DFUs are a major and increasing public health problem o Up to 1 in 4 people with diabetes will suffer from a foot ulcer in their lifetime 2 1. Boulton AJM, et al. Diabetes Care. 2008; 31(8):1679-1685. 2. Singh N, et al. JAMA. 2005;293(2):217-228. 7
Impact of Diabetic Foot Ulcers: Prognosis After Initial Amputation 150 legs are amputated everyday Additional amputations 1 9% to 20% of patients experienced an additional second-leg amputation within 1 year 28% to 51% have a second amputation within 5 years of the initial amputation Mortality following lower-extremity amputation 1 Peri-operative mortality averages 5.8% 5-year mortality rate is 39% to 68% 1. Reiber GE et al. In: Harris MI et al, eds. Diabetes in America. 2nd ed. NIH Publication No. 95-1468; 1995:409-428. 15 Healing of Neuropathic Diabetic Ulcers: Results of a Meta-analysis These data provide clinicians with a realistic assessment of their chances of healing neuropathic DFUs Even with good, standard wound care, * healing neuropathic DFUs in patients with diabetes continues to be a challenge *good, standard wound care included debridement, saline-moistened gauze and offloading Margolis DJ, et al. Diabetes Care. 1999; 5:692-695. 16 8
ADA Consensus Development Conference on Diabetic Foot Wound Care (1999) The American Diabetes Association Consensus Development Conference on Diabetic Foot Wound Care convened in April 1999 Regarding the treatment of diabetic foot wounds, the panel agreed: Any wound that remains unhealed after 4 weeks is cause for concern, as it is associated with worse outcomes Note: This consensus statement also was reviewed and endorsed by the American Podiatric Medical Association. American Diabetes Association. Diabetes Care. 1999;22(8):1354-60. 17 Diabetes Diabetes Microvascular disease 26 million Americans 27% of all Medicare recipients Almost inevitable over time Neuropathy Lifetime prevalence of 70-80% 40% will develop significant symptoms Foot ulcers Lifetime prevalence of 15-25% Risk of recurrence within 2 years > 50% Amputation 20% of diabetic foot ulcers result in amputation 80,000 leg/foot amputations/year 18 9
Effective DFU Prevention Program (DFUPP) Screen all Diabetic Patients and stratify them into risk groups (i.e. low, moderate, high risk for ulcerations) by screening for neuropathy and PAD. Institute Diabetic Foot Ulcer Prevention Program via education for all patients with DM Develop a plan of care for all individuals with DFUs on outpatient basis Create a Rapid Response Team for individuals with a DFU/foot infections Create Utilization Review (UR) for all individuals with DFUs/foot infections 19 Benefits of DFUPP Reduce ulcerations Reduce amputations Reduce hospitalizations Reduce Emergency room visits Reduce re-admissions Reduce COST Improve Outcomes by decreasing amputations Improve patient satisfaction Become Center of Excellence Model for Management of DFUs/foot infections 20 20 10
Prevalence Based on Race Age 20 and older: 7.1% Non-Hispanic 8.4% Asian American 12.6% Non Hispanic Black 11.8% Hispanic Among Hispanics: 7.6% Cuban 13.3% Mexican American 13.8% Puerto Rican How Can We Help? Specifically, how can we reduce the lower limb complications secondary to Diabetes Mellitus? How can we reduce the rates of ulceration(s)? How can we reduce the rates of lower extremity amputation(s)? How can we reduce organizational expenditure? How can we expose organizational risk? How can we improve patient quality of life measures? How can we improve patient centered productivity (return to work force)? 11
The Limb Preservation Platform Mission: The systematic implementation of strategic multidisciplinary risk mitigation groups (RMG s) to screen, risk stratify, and create action plans (CAP s). Purpose: Recognition of diabetic limb preservation as the model of excellence. We believe the future of medicine is screening and risk exposure with early intervention. Goal: A global reduction in rates of ulceration(s) and or amputation(s) via utilization of the aforementioned. Model: Pathway to Prevention, early intervention, and maintenance. Sustainability: Based on outcome measures via central registry. The Limb Preservation Platform The goal of the risk mitigation group (RMG) is to utilize existing physical facilities and current infrastructure to implement a screening and risk stratification model. Screening and risk stratification will be exclusive for the diabetic lower extremity in an attempt to expose risk and reduce rates of ulceration and amputation in the communities served. 12
Economic Burden of the At Risk Limb Total estimated costs of diagnosed DM increased 41%, to $245 billion in 2012 from $174 billion in 2007 Direct medical costs in 2012 $176 billion Indirect medical costs $69 billion Medical expenditure for people with DM is 2.3 times higher than those without More than I in 10 health care dollars in the US are spent directly on diabetes and its complications More than 1 In 5 health care dollars in the US goes to the care of people with diagnosed diabetes Most of the cost for diabetes care, 62.4% is government insurance (CMS / military) Private insurance second at 34.4%, and uninsured 3.2% California has the largest diabetic population and the largest associated cost, at $27.6 billion People with DM but no insurance have 55% more ED visits than people with DM and insurance DFUs The cost to treat a DFU over a two year period after detection in 2011 was $51,531 Neuropathic ulcers carry a 5 year 50% mortality 15-20% of DFUs result in non-traumatic lower extremity amputations 85% of non-traumatic lower extremity amputations in patients with DM are preceeded by a DFU 75,000 in 2003 Average cost $40,000/Amputation 5.5 amps/1000 DM 0.2 Amps/1000 non-dm Non-Traumatic Lower extremity Amputation QUESTIONS? 13