Human Wound and Its Burden: Updated 2020 Compendium of Estimates.

Significance: Chronic wounds impact the quality of life (QoL) of nearly 2.5% of the total population in the United States and the management of wounds has a significant economic impact on health care. Given the aging population, the continued threat of diabetes and obesity worldwide, and the persistent problem of infection, it is expected that chronic wounds will continue to be a substantial clinical, social, and economic challenge. In 2020, the coronavirus disease (COVID) pandemic dramatically disrupted health care worldwide, including wound care. A chronic nonhealing wound (CNHW) is typically correlated with comorbidities such as diabetes, vascular deficits, hypertension, and chronic kidney disease. These risk factors make persons with CNHW at high risk for severe, sometimes lethal outcomes if infected with severe acute respiratory syndrome coronavirus 2 (pathogen causing COVID-19). The COVID-19 pandemic has impacted several aspects of the wound care continuum, including compliance with wound care visits, prompting alternative approaches (use of telemedicine and creation of videos to help with wound dressing changes among others), and encouraging a do-it-yourself wound dressing protocol and use of homemade remedies/substitutions. Recent Advances: There is a developing interest in understanding how the social determinants of health impact the QoL and outcomes of wound care patients. Furthermore, addressing wound care in the light of the COVID-19 pandemic has highlighted the importance of telemedicine options in the continuum of care. Future Directions: The economic, clinical, and social impact of wounds continues to rise and requires appropriate investment and a structured approach to wound care, education, and related research.

Health service organisation impact on lower extremity amputations in people with type 2 diabetes with foot ulcers: systematic review and meta-analysis.

AIMS: Despite the evidence available on the epidemiology of diabetic foot ulcers and associated complications, it is not clear how specific organizational aspects of health care systems can positively affect their clinical trajectory. We aim to evaluate the impact of organizational aspects of care on lower extremity amputation rates among people with type 2 diabetes affected by foot ulcers. METHODS: We conducted a systematic review of the scientific literature published between 1999 and 2019, using the following key terms as search criteria: people with type 2 diabetes, diagnosed with diabetic foot ulcer, treated with specific processes and care pathways, and LEA as primary outcome. Overall results were reported as pooled odds ratios and 95% confidence intervals obtained using fixed and random effects models. RESULTS: A total of 57 studies were found eligible, highlighting the following arrangements: dedicated teams, care pathways and protocols, multidisciplinary teams, and combined interventions. Among them, seven studies qualified for a meta-analysis. According to the random effects model, interventions including any of the four arrangements were associated with a 29% reduced risk of any type of lower extremity amputation (OR = 0.71; 95% CI 0.52-0.96). The effect was larger when focusing on major LEAs alone, leading to a 48% risk reduction (OR = 0.52; 95% CI 0.30-0.91). CONCLUSIONS: Specific organizational arrangements including multidisciplinary teams and care pathways can prevent half of the amputations in people with diabetes and foot ulcers. Further studies using standardized criteria are needed to investigate the cost-effectiveness to facilitate wider implementation of improved organizational arrangements. Similarly, research should identify specific roadblocks to translating evidence into action. These may be structures and processes at the health system level, e.g. availability of professionals with the right skillset, reimbursement mechanisms, and clear organizational intervention implementation guidelines.

Implementing a podiatry prescribing mentoring program in a public health service: a cost-description study.

BACKGROUND: In the management of diabetes and high-risk patients, timely treatment with scheduled medicines is critical to prevent severe infections and reduce the risk of lower extremity amputation. However, in Australia, few podiatrists have attained endorsement to prescribe. The aims of this study were to identify the costs associated with developing and implementing a podiatry prescribing mentoring program; and to compare the cost of this program against potential healthcare savings produced. METHODS: This was a cost-description analysis, involving the calculation of costs associated with the development and implementation of a mentoring program to train podiatrists to become endorsed prescribers. Costs were calculated using the Ingredients Method and examined from the perspective of a public health service provider, and the individual learner podiatrist. Breakeven analysis compared the cost of training a podiatry prescriber for endorsement against the potential benefit (savings) made by averting complications of an infected foot ulcer. A sensitivity analysis was conducted to allow for uncertainty in the results of an economic evaluation. RESULTS: Total start-up cost for the podiatry prescriber mentoring program was $13, 251. The total cost to train one learner podiatrist was $30, 087, distributed between the hospital $17, 046 and the individual learner $13, 041. In the setting studied, a podiatry prescriber must avert 0.40 major amputations arising from an infected foot ulcer through prescribing to recover the cost of training. If in-kind training costs are included, total cost increases to $50, 654, and the breakeven point shifts to 0.68 major amputations averted. CONCLUSION: The economic benefits (savings) created by an endorsed prescribing podiatrist over their career in a public health service are likely to outweigh the costs to train a podiatrist to attain endorsement. Further research is required to help understand the effectiveness of podiatry prescribing in reducing diabetic foot related complications and the potential economic impact of podiatry prescribers on this health condition.

Burden of Infected Diabetic Foot Ulcers on Hospital Admissions and Costs.

BACKGROUND: Costs related to diabetic foot ulcer (DFU) care are greater than $1 billion annually and rising. We sought to describe the impact of diabetes mellitus (DM) on foot ulcer admissions in the United States, and to investigate potential explanations for rising hospital costs. METHODS: The Nationwide Inpatient Sample (2005-2010) was queried using International Classification of Diseases, 9th Revision (ICD-9) codes for a primary diagnosis of foot ulceration. Multivariable analyses were used to compare outcomes and per-admission costs among patients with foot ulceration and DM versus non-DM. RESULTS: In total, 962,496 foot ulcer patients were admitted over the study period. The overall rate of admissions was relatively stable over time, but the ratio of DM versus non-DM admissions increased significantly (2005: 10.2 vs. 2010: 12.7; P < 0.001). Neuropathy and infection accounted for 90% of DFU admissions, while peripheral vascular disease accounted for most non-DM admissions. Admissions related to infection rose significantly among DM patients (2005: 39,682 vs. 2010: 51,660; P < 0.001), but remained stable among non-DM patients. Overall, DM accounted for 83% and 96% of all major and minor amputations related to foot ulcers, respectively, and significantly increased cost of care (DM: $1.38 vs. non-DM: $0.13 billion/year; P < 0.001). Hospital costs per DFU admission were significantly higher for patients with infection compared with all other causes ($11,290 vs. $8,145; P < 0.001). CONCLUSIONS: Diabetes increases the incidence of foot ulcer admissions by 11-fold, accounting for more than 80% of all amputations and increasing hospital costs more than 10-fold over the 5 years. The majority of these costs are related to the treatment of infected foot ulcers. Education initiatives and early prevention strategies through outpatient multidisciplinary care targeted at high-risk populations are essential to preventing further increases in what is already a substantial economic burden.

Descriptive, Longitudinal Study Results Applied to Statistical Models to Assess the Impact of Early Microbiological Cultures on the Economic Burden of Treatment for Infected Diabetic Foot Ulcers at a Mexican Public Health Facility.

Infection plays a critical role in health care and impacts the cost of the treatment of diabetic foot ulcers (DFU). To examine the cost reduction associated with the multidisciplinary treatment of infected DFU (IDFU) by obtaining early (ie, within 48 hours of admission) microbiological culture results, a descriptive, longitudinal study was conducted. Data were collected prospectively from patient medical charts of a cohort of 67 patients (mean age, 56.14 ± 12.3 years; mean duration of diabetes, 14.95 ± 8 years) with IDFU treated at a Mexican public health facility from January 1 to April 30, 2010. Information included demographic data (age, gender, marital status, time elapsed since first diagnosis of diabetes mellitus type 2 [DM2]), and the following clinical records: Wagner classification, bacterium type, antimicrobial resistance, length of hospital stay, and the antibiotic schedule utilized, as well as number and type of laboratory tests, medications, intravenous therapy, surgical and supportive treatment, type and number of specialists, and clinical outcome. Microcosting was used to calculate the unit cost of each medical treatment element. Using the Monte Carlo and Markov predictive simulation economical models, cost reduction associated with early identification of the specific microorganism through bacterial culture in IDFU was estimated. Based on the statistical results, differences between real and estimated costs when including early microbiological culture were identified and the number and type of most common species of infectious bacteria were detected. The total cost observed in the patient cohort was $502 438.04 USD, mean cost per patient was $7177.69 ± $5043.51 USD, and 72.75% of the total cost was associated with the hospital stay length. The cost of the entire treatment including antibiotics was $359 196.16 USD; based on the simulation of early microbiological culture, the model results showed cost could be reduced by 10% to 25% (in this study, the cost could be as low as $304 624.63 USD). The use of early microbiological cultures on IDFU to determine the appropriate antibiotic can reduce treatment costs by >30% if hospital stay is part of the consideration.

Illustration of Cost Saving Implications of Lower Extremity Nerve Decompression to Prevent Recurrence of Diabetic Foot Ulceration.

The US diabetic foot ulcer (DFU) incidence is 3-4% of 22.3 million diagnosed diabetes cases plus 6.3 million undiagnosed, 858 000 cases total. Risk of recurrence after healing is 30% annually. Lower extremity multiple nerve decompression (ND) surgery reduces neuropathic DFU (nDFU) recurrence risk by >80%. Cost effectiveness of hypothetical ND implementation to minimize nDFU recurrence is compared to the current $6.171 billion annual nDFU expense. A literature review identified best estimates of annual incidence, recurrence risk, medical management expense, and noneconomic costs for DFU. Illustrative cost/benefit calculations were performed assuming widespread application of bilateral ND after wound healing to the nDFU problem, using Center for Medicare Services mean expense data of $1143/case for unilateral lower extremity ND. Calculations use conservative, evidence-based cost figures, which are contemporary (2012) or adjusted for inflation. Widespread adoption of ND after nDFU healing could reduce annual DFU occurrences by at least 21% in the third year and 24% by year 5, representing calculated cost savings of $1.296 billion (year 3) to $1.481 billion (year 5). This scenario proffers significant expense reduction and societal benefit, and represents a minimum 1.9× return on the investment cost for surgical treatment. Further large cost savings would require reductions in initial DFU incidence, which ND might achieve by selective application to advanced diabetic sensorimotor polyneuropathy (DSPN). By minimizing the contribution of recurrences to yearly nDFU incidence, ND has potential to reduce by nearly $1 billion the annual cost of DFU treatment in the United States.

Cost-effectiveness of revascularization for limb preservation in patients with marginal functional status.

BACKGROUND: Revascularization and limb salvage attempts are often offered to patients with foot wounds and chronic limb ischemia who are thought to be good-risk candidates, but some skepticism remains about the utility of these efforts for elderly patients with marginal functional status. We sought to determine whether limb preservation efforts in this population could be justified from a patient-centered, cost-effectiveness perspective. METHODS: A probabilistic Markov model was used to simulate the clinical outcomes, health utilities, and costs over a 10-year period with various management strategies. Clinical parameter estimates were obtained from previous clinical trials and large observational series. Cost estimates were obtained from cost literature and also a single-center study that reviewed total costs accumulated (including secondary amputations, wound care, outpatient nursing care, and nursing home costs). Cost (in 2011 U.S. dollars) per year of ambulation (with limb preservation or with a prosthesis after amputation) was the primary measure of cost-effectiveness. RESULTS: The total 10-year costs of revascularization--either endovascular or surgical--were lower than the costs of either local wound care alone or primary amputation. Revascularization strategies also produced more health benefits as measured in terms of years of ambulatory ability, years of limb salvage, or quality-adjusted life-years. In none of the scenarios modeled in deterministic sensitivity analyses did primary amputation prove to be cost-effective. CONCLUSIONS: Revascularization and limb preservation attempts appear less costly and provide more health benefits than wound care alone or primary amputation, even among patients with marginal functional status at baseline.

Custom-made orthesis and shoes in a structured follow-up program reduces the incidence of neuropathic ulcers in high-risk diabetic foot patients.

OBJECTIVE: The objective of this study was to assess the impact of a structured follow-up program on the incidence of diabetic foot ulceration (DFU) in high-risk diabetic patients. RESEARCH DESIGN AND METHODS: A total of 1874 diabetic patients referred to the Diabetic Foot Unit of the University of Pisa were ranked based on the ulcerative risk score proposed by the International Consensus on Diabetic Foot. Out of 334 patients (17.8%) with a score ≥2, 298 accepted to participate in this prospective trial and were randomized into 2 groups: group A, which received standard treatment, and group B, in which the patients received, as a part of a structured prevention program, custom-made orthesis and shoes. Incidence of new DFUs was observed for no less than 1 year and in a subset of patients after 3 and 5 years, respectively. Incidence of new DFUs and recurrences were considered as primary endpoints to establish the effectiveness of the program; costs were also compared. RESULTS: Among the patients enrolled in this follow-up analysis, 46% had neuropathy and deformities, 20% had previous ulceration, 25% had previous minor amputation, and 9% had neuro-osteoarthropathy. During the first 12-month follow-up, 11.5% of patients in group B developed a DFU compared with 38.6% in group A (P < .0001). In the extended follow-up, the cumulative incidence of ulcer in group B compared with group A was 17.6% versus 61% (P < .0001) after 3 years and 23.5% versus 72% (P < .0001) after 5 years, respectively. The net balance at the end of the follow-up was highly in favor of the prevention program, with a saving of more than €100 000 per year. CONCLUSIONS: The implementation of a structured follow-up with the use of orthesis and shoes can reduce the incidence of DFU in diabetic patients who are at high ulcerative risk and its related costs.

A review of the Eurodiale studies: what lessons for diabetic foot care?

The prevalence of diabetes has been increasing at an alarming rate worldwide. Treatment of diabetes-related complications adds a huge financial burden on our health services, made worse in the current financial climate. The Eurodiale (European Study Group on Diabetes and the Lower Extremity) study was a prospective observational study conducted in 14 European centers in 2003 to 2004 and included data on characteristics of diabetic patients with foot ulcers, diagnostic and management procedures, health care organization, quality of life, and resource use. This was the first large multicenter study, included 1232 patients, and used an integrated approach for a multiorgan disease. The study has provided new insights into the intricacies involved in managing diabetic foot ulcers and how care can be improved. It has shown the differences in quality of care provided in different centers and also highlighted the need for more specific guidance related to diabetic foot disease.

The quality of life and economic burden of neuropathy in diabetic patients in Germany in 2002--results from the Diabetic Microvascular Complications (DIMICO) study.

OBJECTIVE: To describe the health-related quality of life (HRQOL), the resource utilization and annual costs associated with diabetic neuropathy (DN) in Germany. METHODS: In this retrospective, observational study German internists, diabetologists and general practitioners provided information on 185 adult type 1 and type 2 diabetic patients with DN. Health-related quality of life (HRQOL) was assessed using generic and disease specific questionnaires. Socio-demographic and resource use data were assessed from medical charts and through patient interviews. Based on these results, national-level cost estimates were calculated using German unit costs. RESULTS: The majority of DN patients were severely impaired with regard to general physical HRQOL. Disease specific HRQOL decreased continuously with increasing DN severity. In accordance, costs associated with DN increased as DN progressed, with costs from the societal perspective increasing about 50-fold from the lowest severity stage (patients with sensory-motor neuropathy without symptoms) (euro431) to patients with lower extremity amputation in the year 2002 (euro21,476). The German statutory health insurance covered more than two thirds of the total costs of DN. CONCLUSIONS: The results described in this report show that diabetic neuropathy in adults with type 1 or type 2 diabetes generates significant reductions in the patient's quality of life and a substantial economic burden both for society and health insurance.

The foot in perspective.

The diabetic foot constitutes a tremendous challenge for patients, caregivers and the health care system. The International Consensus Document of 1999 was a milestone in the recognition of the importance and consequences of the diabetic foot. Since then, many original papers have been published in this area. Large cohort studies have given us a deeper understanding regarding factors related to the outcome of diabetic foot ulcers: according to these studies, the severity of diabetic foot ulcers is greater than previously reported. More than 50% of individuals' foot ulcers have signs of infection at admission, and one-third have signs of both peripheral artery disease (PAD) and infection. The co-morbidities increase significantly with increasing severity of the foot disease. However, the trend in all these studies is a successive improvement in healing rate (50-60% at 20 weeks follow-up, > 75% at 1 year). It is important to differentiate between neuropathic and neuro-ischaemic ulcers with regard to factors related to outcome and co-morbidities.Recent research has emphasized the importance of psychological factors in the development and outcome of diabetic foot ulcers. Studies have shown that perceptions of the individual's own risks based on symptoms, and their own beliefs in the efficacy of self-care, can affect foot-care practice.The importance and influence of the health care organization and reimbursement should not be underestimated, both in the prevention and management of diabetic foot lesions. The diabetic foot should be considered a lifelong condition, as having had one ulcer dramatically increases the risk of developing a new ulcer. In an individual with diabetes and a foot ulcer, the ulcer should be considered as a sign of multi-organ disease, and a holistic approach to both management and prevention is recommended.

Costs of lower-extremity ulcers among patients with diabetes.

OBJECTIVE: The objective of this study was to characterize health care costs associated with diabetic lower-extremity ulcers. RESEARCH DESIGN AND METHODS: Adult patients with diabetes who had a lower-extremity ulcer episode during 2000 and 2001 were identified using claims data. Ulcer-related direct health care costs were computed for each episode. Episodes were stratified according to severity level based on the Wagner classification. RESULTS: A total of 2,253 patients were identified. The mean age was 68.9 years, and 59% of the patients were male. The average episode duration was 87.3 +/- 82.8 days. Total ulcer-related costs averaged 13,179 dollars per episode and increased with severity level, ranging from 1,892 dollars (level 1) to 27,721 dollars (level 4/5). Inpatient hospital charges accounted for 77% (10,188 dollars) of the overall cost, indicating that hospitalization was a major cost driver. Total ulcer-related costs were significantly higher for patients <65 years of age compared with those of older patients (16,390 dollars vs. 11,925 dollars, P = 0.02) and for patients with inadequate vascular status compared with patients with adequate vascular status (23,372 dollars vs. 5,218 dollars, P < 0.0001). Patients who progressed to a higher severity level also had significantly higher ulcer-related costs compared with patients who did not progress (20,136 dollars vs. 3,063 dollars, P < 0.0001). CONCLUSIONS: The high costs of treating diabetic lower-extremity ulcers emphasize the value of intensive outpatient interventions designed to prevent ulcer progression.

A cost analysis of diabetic lower-extremity ulcers.

OBJECTIVE: Our objectives were to 1) estimate the prevalence of diabetes and diabetic lower-extremity ulcers in the Medicare population, 2) characterize Medicare population-specific costs for lower-extremity ulcer episodes, and 3) evaluate potential cost savings associated with better healing of lower-extremity ulcers. RESEARCH DESIGN AND METHODS: Prevalence and costs of diabetic lower-extremity ulcers were obtained by an analysis of Medicare claims data from 1995 and 1996 Standard Analytic Files (5% sample). RESULTS: Medicare expenditures for lower-extremity ulcer patients were on average 3 times higher than those for Medicare patients in general ($15,309 vs. $5,226). Lower-extremity ulcer-related spending accounted for 24% of total spending for lower-extremity ulcer patients. Most of the ulcer-related costs accrued on the inpatient side (73.7%); proportionately smaller amounts went to physicians and nursing home facilities. To determine the potential effect of better diabetic ulcer management, a model was created that estimated the impact on costs with improved healing rates. Improving the 20-week healing rate from 31 to 40% would save Medicare $189 per episode. CONCLUSIONS: Lower-extremity ulcers cost the Medicare system $1.5 billion in 1995. Any wound care intervention that could prevent even a small percentage of wounds from progressing to the stage at which inpatient care is required may have a favorable cost effect on the Medicare system.

Incidence, outcomes, and cost of foot ulcers in patients with diabetes.

OBJECTIVE: To determine the incidence of foot ulcers in a large cohort of patients with diabetes, the risk of developing serious complications after diagnosis, and the attributable cost of care compared with that in patients without foot ulcers. RESEARCH DESIGN AND METHODS: Retrospective cohort study of patients with diabetes in a large staff-model health maintenance organization from 1993 to 1995. Patients with diabetes were identified by algorithm using administrative, laboratory, and pharmacy records. The data were used to calculate incidence of foot ulcers, risk of osteomyelitis, amputation, and death after diagnosis of foot ulcer, and attributable costs in foot ulcer patients compared with patients without foot ulcers. RESULTS: Among 8,905 patients identified with type 1 or type 2 diabetes, 514 developed a foot ulcer over 3 years of observation (cumulative incidence 5.8%). On or after the time of diagnosis, 77 (15%) patients developed osteomyelitis and 80 (15.6%) required amputation. Survival at 3 years was 72% for the foot ulcer patients versus 87% for a group of age- and sex-matched diabetic patients without foot ulcers (P < 0.001). The attributable cost for a 40- to 65-year-old male with a new foot ulcer was $27,987 for the 2 years after diagnosis. CONCLUSIONS: The incidence of foot ulcers in this cohort of patients with diabetes was nearly 2.0% per year. For those who developed ulcers, morbidity, mortality, and excess care costs were substantial compared with those for patients without foot ulcers. The results appear to support the value of foot-ulcer prevention programs for patients with diabetes.

Potential economic benefits of lower-extremity amputation prevention strategies in diabetes.

OBJECTIVE: To estimate the potential economic benefits of selected strategies from published literature--educational interventions, multidisciplinary clinics, and insurance coverage for therapeutic shoes--to reduce the incidence of lower-extremity amputation among individuals with diabetes. RESEARCH DESIGN AND METHODS: We developed a model to estimate the expected incidence and associated costs of lower-extremity amputation in a hypothetical cohort of 10,000 people with diabetes. Prevention strategies were assumed to be targeted at individuals with a history of foot ulcer, and benefits were estimated over a period of 3 years. RESULTS: The total potential economic benefits (discounted at 5%) of strategies to reduce amputation risk ranged from $2.0 to $3.0 million ($2,900 to $4,442 per person with a history of foot ulcer) over 3 years. Benefits were highest for educational interventions. Most benefits were found to accrue among individuals aged > or = 70 years. CONCLUSIONS: Strategies to reduce the risk of lower-extremity amputation may generate substantial economic benefits and should be a standard component of routine diabetes care. Benefits may best be achieved through a partnership of government, private payers, health care service providers and producers, and individuals with diabetes.

Costs and duration of care for lower extremity ulcers in patients with diabetes.

Medical and pharmaceutical insurance claims associated with lower extremity diabetic ulcers were examined retrospectively to better understand the costs and duration of treatment in clinical practice. The study population consisted of working-age individuals (18 to 64 years old) with health care benefits provided through private employer-sponsored insurance plans. Diagnostic information contained in the claims database was used to identify the severity of the ulcers, and the charges associated with treatment were based on claims data. Claims for lower extremity ulcers were found in 5.1% of individuals with diabetes. Although many lower extremity ulcers heal with standard treatment, some are more resistant to treatment and require costly ongoing medical care. Almost half of these cases were associated with deep infection, osteomyelitis, or amputation. Total payments for treatment of lower extremity ulcers in this population averaged $2687 per patient per year, or $4595 per ulcer episode, with inpatient expenditures accounting for more than 80% of these costs. Costs were significantly higher for patients with more severe ulcers or with inadequate vascular status in the affected limb. We concluded that lower extremity ulcers occur in a large number of working-age people with diabetes and contribute significantly to the morbidity associated with this disease. The high cost of treating diabetic foot ulcers suggested by this analysis argues for the development of better treatment strategies and outcomes assessments for these patients.

Assessing the risk of foot ulcers.

Home care nurses are in an ideal position to screen clients and assess their risk of developing foot-related problems, including ulcers. An increased awareness of the potential serious consequences of foot ulcers together with agency assessment and practice guidelines, will help nurses prevent foot-related problems.