DFU—The Facts You Need to Know DIABETIC FOOT ULCERS DFU—The Facts You Need to Know Advances in Wound Healing 2019 UPMC Passavant Wound Healing Services September 13, 2019 Michael Ryan, DPM Diabetic foot ulcers

Objectives Learn about the economic impact of diabetic foot ulcers (DFU’s) Understand the mortality associated with DFU’s Identify the difficulties of treating DFU’s and when to change the treatment course

Diabetes in America CDC report 2017

Diabetes in America Without major changes 1 in 3 US adults could have diabetes by year 2050 The more alarming issue related to diabetes is the overall population with a “pre-diabetes’ diagnosis -Pre-diabetes HbA1c is considered to be within the range of 5.7 – 6.4 % People with prediabetes who take part in a structured lifestyle change program can cut their risk of developing type 2 diabetes by as much as 58%. So why is this concerning?? THE COST!!!!

Diabetes in America Total cost for indirect and direct costs of diagnosed diabetes in the US in 2012 was $245 billion Average medical expenditures for people with diagnosed diabetes was about $13,700 per year. About $7900 of the $13700 was due to diabetes Additionally, the average medical expenditures among people with a diabetes diagnosis  2.3 x more than people without diabetes

costs DFU 9-13 billion per year in U.S. U.K. 1.32 billion/year and is roughly 1% of total health budget World wide $1.3 trillion of diabetes.

Economics of Limb Salvage What the past few slides have proven is that DFU’s result in a marked increase in health care costs.   Research shows the direct cost to treat a DFU within the 1st 2 years of its development to be approximately $28,000. This slide also shows us these costs for 2000, 2005 and 2010. These values have been adjusted for medical care increases based on information provided to the bureau of labor statistics. This information is based on retrospective data that compared 1. diabetic patients with a newly diagnosed DFU 2. a control group of diabetics with no history of DFU’s DFU group  0.24 more ED visits  22 more outpatient appointments  4.6 more hospital stays within the first year  higher risk for development of osteomyelitis and amputation, which also adds to the overall healthcare cost

Economics of Limb Salvage -Active management programs  educational services, routine foot care, accessibility for early management of injuries, onsite fabrication of orthotics, casts and footwear -Standard Care  care of the wounds in PCP clinics, ED, and in wound care/surgical/podiatry offices Furthermore, research proves that the cost to treat DFU’s with an active management program vs standard care can effect cost 1 year period, the costs of each program was measured -Active management programs  educational services, management of complex nail and callus problems, accessibility for early management of injuries, onsite fabrication of orthotics, casts and footwear -Standard Care  care of the wounds in PCP clinics, ED, and in wound care/surgical/podiatry offices Patout et al. Diabetes Care 2000

Economics of Limb Salvage Active programs utilize more outpatient visits but far less cost than standard care programs due to hospital admissions -average cost of treatment of a DFU within that 1 year period are listed above, showing that 1. Active care costs more than standard care for outpatients visit 2. When compared to inpatient charges, standard care of DFU’s cost exponentially more than the active programs Outpatient active - $2169 Outpatient standard - $1497 Inpatient active - $4776 Inpatient standard - $9402 Patout et al. Diabetes Care 2000

DFU cost Hicks et al 2017 Society for Vascular Surgery Wound episode costs Wound severity associated with higher costs $3995 stage 1(WIfI) to $50,546 stage 4 Worsening wound increases time to heal and overall number of procedures. 104 days(stage 1) vs. 217 days(stage 4) Society for Vascular Surgery Wound prognosis based on wound characteristics, level of ischemia, infection burden

DFU Costs:Profitability of Multi-disciplinary approach Hicks et al 2018 Society for Clinical Vascular Surgery Mean cost per wound episode $24,226 Mean net margin $2412 per wound episode Roughly 90% of income from treatment was used to pay overhead. Mean time to healing 136 days Study conclusion is that team approach is expensive, results are good but reimbursement needs re-evaluated.

Economics of Limb Salvage majority of costs for diabetic foot problems is related to hospital admissions Most cost effective ways to reduce amputation rates: PREVENTION EARLY DETECTION QUICK INTERVENTION -in 2011 this study was followed up and showed that 9-20% of all DFU’s require hospitalization  major cost treating DFU is inpatient care, accounting for 74-84% of total costs

Diabetic Foot Ulcers It is important to identify the risk factors in diabetic patients to prevent these hospitalizations These may be distinguished by general or systemic considerations vs. those localized to the foot and its pathology. Local issues are related to 3 main issues 1. neuropathy 2. foot deformity 3. trauma

Increased localized pressure Diabetic Foot Ulcers Increased localized pressure Insensate foot ULCER Images show high risk areas in diabetic patients due to the areas of increased pressure Area of increased pressure Patient unable to feel this increased pressure Result is an ulceration

Diabetic Foot Ulcers This was further noted in a study that identified causal pathways responsible for 80 consecutive lower extremity amputations in diabetics -looked at 7 potential cause - ischemia, infection, neuropathy, faulty wound healing, minor trauma, cutaneous ulceration, gangrene  most common pathway included minor trauma,, ulceration and faulty healing was noted in 72% of these cases -often with the association of infection or gangrene Defining causal pathways that predispose to diabetic limb amputation suggests practical interventions that may be effective in preventing diabetic limb loss. The causal sequence of minor trauma, cutaneous ulceration, and wound-healing failure applied to 72% of the amputations, often with the additional association of infection and gangrene. We specified precise criteria in the definition of causal pathway to permit estimation of the cumulative proportion of amputations due to various causes. Forty-six percent of the amputations were attributed to ischemia, 59% to infection, 61% to neuropathy, 81% to faulty wound healing, 84% to ulceration, 55% to gangrene, and 81% to initial minor trauma. An identifiable and potentially preventable pivotal event, in most cases an episode involving minor trauma that caused cutaneous injury, preceded 69 to 80 amputations.

This image continues to show that ulcers develop for many reasons and are associated with several comorbidities Forty-six percent of the amputations were attributed to ischemia, 61% to neuropathy

Diabetes and Amputation Estimated that somewhere in the world a limb is lost every 20 seconds due to diabetes Following an amputation in a patient with diabetes 30% will lose the other leg within 3 years 50% mortality within 5 years Now that we understand that DFU’s are costly to treat, we should talk about the prevalence of these wounds and how they lead to amputation

Diabetes and Amputation 2-4% incidence per year Mexican Americans 6% VA population 5% 15-25% lifetime risk Amputation risk increase by 800% once an ulcer develops Diabetic related amputations are preceded by ulcers 85% of the time The key here is preventing ulceration because as you can see, the amputation risk is exponentially higher once an ulcer develops

Diabetes and Amputation Recurrence rates are high 1 year 34% 3 year 61% 5 year 70% Amputation rates 1 year 3% 3 years 10% 5 years 12% Once that ulcer develops it is likely to return, ultimately leading to amputations -> and some times much worse as it may lead to mortality as well

DFU and Mortality This article evaluated the limb and person survival in DFU patients in a follow up of over 10 years Time to first amputation vs time to death  LONG TERM LIMB SALVAGE IS FAVORABLE BUT LONG TERM PATIENT SURVIVAL IS POOR  measured both at years 1, 3, 5 and 10  year 1: 9% had amputation, 15% die  year 10: 23% had amputation, 70% of patients die  other factors measured in this study were PAD and chronic renal insufficiency

Diabetes and Mortality This again emphasizes the long term prognosis of patient survival is low at the 5 year marker  measure both patients with a healed DFU versus a amputation after a DFU and how they compared to different types of cancer and other comorbidities that we commonly treat -melanoma, breast cancer, heart failure, and lung cancer

DFU severity predicts mortality among Veterans Brennan et al 2017 J. Diabetes Complications 1,2, and 5 year survival was 81%, 69%, 29% Mortality and DFU was stonger than that of any Macrovascular Disease.

DFU’s and Wound Care So clearly this is a major health concern and I’m not here to scare you but the real questions is --? What can we do to change these outcomes We always start with a foundation in the treatment of wounds to include Offloading – for pressure reduction Sharp debridement – weekly, to convert to acute wound Moist wound therapy – to promote granulation But what about the length of time you should treat an ulcer and also when do you need to make the change in your treatment course and alter from the foundation

Margolis et al. Diabetes Care. 1999;22:692. DFU’s and Wound Care Even with standard wound care, healing neuropathic ulcers in patients with diabetes is a challenge A meta-analysis evaluated the percentage of healing in individuals with neuropathic DFU’s receiving good wound care within a defined period of time. -both 12 and 20 weeks   -treatment included: debridement and offloading and then 1 of 2 treatments: -saline-moistened gauze -placebo gel and gauze gives us a realistic assessment of the percent of wounds that heal after 20 weeks  even with good wound care, healing neuropathic ulcers in patients with diabetes is very challenging -20 weeks is 5 months!!!! -only 31% of DFU’s heal within 5 months Margolis et al. Diabetes Care. 1999;22:692.

DFU’s and Wound Care A large, prospective, multicenter trial of DFU’s Ability of the 4-week healing rate to predict complete healing within a 12-week period was assessed In 203 patients, the study results showed: Patients in whom ulcer size fails to reduce by 50% over the first few weeks of treatment are unlikely to achieve complete wound healing The previous study shows many things  one of those is that the healing rate for DFU’s is relatively low over an extended period of time. So when do we need to make a change to get the wound healed faster? It has been suggested that after 4 weeks of good, standard DFU care, wounds should be reassessed for progress, and reduction in ulcer size should be used as a predictive marker.

DFU’s and Wound Care So…at 4 weeks, this proves that 1. if ulcer size was not reduced by over half in the 1st 4 weeks of treatment were unlikely to achieve wound healing over a reasonable period. Note: Complete wound healing was defined as 100% re-epithelialization of the wound surface with the absence of drainage.

Make the change! < 50% area reduction in 4 weeks Proceed to Advanced Wound Therapy (Consider HBO Therapy) We have several modalities at our disposal in terms of advanced wound therapy Grafts, skin substitutes, surgical intervention So if your foundation starts to fail, it may be a good idea to look at other options

Effectiveness of Existing Treatments Jeffcoate et al 2018 Diabetes Care “Overall conclusion is that evidence available from published studies is of insufficient quality to recommend any particular treatment or dressing product in preference to any other.” Main exception is offloading plantar foot ulcers.

Thank you Any questions