Measuring costs and quality of life for venous leg ulcers.

Venous leg ulcers (VLUs) result in substantial economic costs and reduced quality of life (QoL); however, there are few Australian cost estimates, especially using patient-level data. We measured community-setting VLU management costs and the impact on the QoL of affected individuals. VLU patients were recruited from a specialist wound clinic, an outpatient clinic, and two community care clinics in Queensland. Cost data were collected at the baseline visit. QoL (EQ-5D-5L) and wound status data were collected at baseline, 1, 3, and 6 months. Patients were classified into guideline-based/optimal care and usual care groups. Average weekly costs per patient were statistically significantly different between the usual care and optimal care groups-$214.61 and $294.72, respectively (P = 0.04). Baseline average QoL score for an unhealed ulcer was significantly higher in the optimal care group compared with usual care (P = 0.025). Time to healing differed between the usual care group and the optimal care group (P = 0.04), with averages of 3.9 and 2.7 months, respectively. These findings increase the understanding of the costs, QoL, and healing outcomes of VLU care. Higher optimal care costs may be offset by faster time to healing. This study provides data to inform an economic evaluation of guideline-based care for VLUs.

Updated leg ulcer pathway: improving healing times and reducing costs.

Regardless of the amount of literature and evidence on leg ulcer management, there are still significant variations in treatment. Implementing a standardised leg ulcer pathway to ensure patients are appropriately and timely assessed could help reduce nursing time and overall costs, while improving healing outcomes and patients' quality of life. Such a pathway was introduced in Lincolnshire and Leicestershire, UK, to treat venous leg ulcers (VLUs). The results showed improved healing times, reduced costs and fewer nurse visits, among other findings.

Cost-effectiveness analysis of guideline-based optimal care for venous leg ulcers in Australia.

BACKGROUND: Venous leg ulcers (VLUs) are expensive to treat and impair quality of life of affected individuals. Although improved healing and reduced recurrence rates have been observed following the introduction of evidence-based guidelines, a significant evidence-practice gap exists. Compression is the recommended first-line therapy for treatment of VLUs but unlike many other developed countries, the Australian health system does not subsidise compression therapy. The objective of this study is to estimate the cost-effectiveness of guideline-based care for VLUs that includes public sector reimbursement for compression therapy for affected individuals in Australia. METHODS: A Markov model was designed to simulate the progression of VLU for patients receiving guideline-based optimal prevention and treatment, with reimbursement for compression therapy, and then compared to usual care in each State and Territory in Australia. Model inputs were derived from published literature, expert opinion, and government documents. The primary outcomes were changes to costs and health outcomes from a decision to implement guideline-based optimal care compared with the continuation of usual care. Sensitivity analyses were performed to test the robustness of model results. RESULTS: Guideline-based optimal care incurred lower total costs and improved quality of life of patients in all States and Territories in Australia regardless of the health service provider. We estimated that providing compression therapy products to affected individuals would cost the health system an additional AUD 270 million over 5 years but would result in cost savings of about AUD 1.4 billion to the health system over the same period. An evaluation of unfavourable values for key model parameters revealed a wide margin of confidence to support the findings. CONCLUSIONS: This study shows that guideline-based optimal care would be a cost-effective and cost-saving strategy to manage VLUs in Australia. Results from this study support wider adoption of guideline-based care for VLUs and the reimbursement of compression therapy. Other countries that face similar issues may benefit from investing in guideline-based wound care.

Venous leg ulcer management in clinical practice in the UK: costs and outcomes.

The aim of this study was to estimate the patterns of care and annual levels of health care resource use attributable to managing venous leg ulcers (VLUs) in clinical practice by the UK's National Health Service (NHS) and the associated costs of patient management. This was a retrospective cohort analysis of the records of 505 patients in The Health Improvement Network (THIN) Database. Patients' characteristics, wound-related health outcomes and health care resource use were quantified, and the total NHS cost of patient management was estimated at 2015/2016 prices. Overall, 53% of all VLUs healed within 12 months, and the mean time to healing was 3·0 months. 13% of patients were never prescribed any recognised compression system, and 78% of their wounds healed. Of the 87% who were prescribed a recognised compression system, 52% of wounds healed. Patients were predominantly managed in the community by nurses with minimal clinical involvement of specialist clinicians. Up to 30% of all the VLUs may have been clinically infected at the time of presentation, and only 22% of patients had an ankle brachial pressure index documented in their records. The mean NHS cost of wound care over 12 months was an estimated £7600 per VLU. However, the cost of managing an unhealed VLU was 4·5 times more than that of managing a healed VLU (£3000 per healed VLU and £13 500 per unhealed VLU). This study provides important insights into a number of aspects of VLU management in clinical practice that have been difficult to ascertain from other studies and provides the best estimate available of NHS resource use and costs with which to inform policy and budgetary decisions.

Cost-of-illness studies in chronic ulcers: a systematic review.

OBJECTIVE: To systematically review the published academic literature on the cost of chronic ulcers. METHODS: A literature search was conducted in MEDLINE, EMBASE, HealthSTAR, Econlit and CINAHL up to 12 May 2016 to identify potential studies for review. Cost search terms were based on validated algorithms. Clinical search terms were based on recent Cochrane reviews of interventions for chronic ulcers. Titles and abstracts were screened by two reviewers to determine eligibility for full text review. Study characteristics were summarised. The quality of reporting was evaluated using a modified cost-of-illness checklist. Mean costs were adjusted and inflated to 2015 $US and presented for different durations and perspectives. RESULTS: Of 2267 studies identified, 36 were eligible and included in the systematic review. Most studies presented results from the health-care public payer or hospital perspective. Many studies included hospital costs in the analysis and only reported total costs without presenting condition-specific attributable costs. The mean cost of chronic ulcers ranged from $1000 per year for patient out of pocket costs to $30,000 per episode from the health-care public payer perspective. Mean one year cost from a health-care public payer perspective was $44,200 for diabetic foot ulcer (DFU), $15,400 for pressure ulcer (PU) and $11,000 for leg ulcer (LU). CONCLUSIONS: There was large variability in study methods, perspectives, cost components and jurisdictions, making interpretation of costs difficult. Nevertheless, it appears that the cost for the treatment of chronic ulcers is substantial and greater attention needs to be made for preventive measures.

Epidemiology of chronic wounds in Germany: Analysis of statutory health insurance data.

Epidemiologic analyses in routine care of chronic wounds are scarce, and published studies show wide variations. This study analyzes the population-based prevalence and incidence of chronic wounds in Germany. Secondary analyses of data from a German statutory health insurance with about 9 million insured persons were examined (2010 to 2012). Internal diagnostic validations were used to control for different inclusion criteria. In 2012, 1.04% (95% CI 1.03-1.05) of insured patients had a wound diagnosis, including 0.70% with leg ulcers and 0.27% with diabetic ulcers. Wound treatment was received by 0.43% (0.43-0.44) of patients. Prevalence and incidence increased over 3 years. Extrapolated to the German population, there were 786,407 prevalent and 196,602 incident chronic wounds, including 326,334/172,026 patients who underwent wound-relevant treatment in 2012. There is an annually increasing frequency of chronic wounds in Germany. Chronic wound epidemiology is sensitive to wound treatment as a filter criterion.

Outcomes of neuroischemic wounds treated by a multidisciplinary amputation prevention service.

BACKGROUND: Multidisciplinary amputation prevention teams decrease the frequency of major amputations by increasing the use of revascularization procedures and minor amputations. The outcomes of wound healing, wound recurrence, and ambulatory status are assumed to be improved but are not routinely reported. This study investigates the midterm outcomes of neuroischemic wounds treated by our multidisciplinary team. METHODS: A retrospective review of patients with neuroischemic wounds treated at a single institution amputation prevention clinic from March 2012 to July 2013. Patient demographics, wound characteristics, procedural details, and clinical and functional outcomes were reviewed. Clinical end points under study included time to wound healing, reulceration rate, and ambulatory status. RESULTS: Over 16 months, there were 202 new patients and 1,355 clinic visits. Ninety-one limbs from 89 patients were treated for complex neuroischemic wounds. In 67% (61 of 91) of limbs, wounds were present for >6 weeks before referral. A history of previous revascularization was present in 39% (31 of 91), and 28% (22 of 91) had a previous minor amputation. Forty-one percent of wounds (38 of 91) were limited to the toes or the forefoot whereas 24% (22 of 91) involved the hindfoot or ankle. A total of 151 podiatric and 86 vascular interventions were performed, with an equal distribution of endovascular and open revascularizations. Complete healing was observed for 59% of wounds (54 of 91) over the observation period (median follow up, 207 days; range 56-561 days), and the average time to full healing was 12 weeks. Hindfoot wounds were predictive of failure to heal (odds ratio, 0.21; P < 0.01; 95% confidence interval, 0.06-0.68). Nineteen percent of patients (17 of 91) developed a new wound in the ipsilateral leg during follow-up. Three major amputations were performed (2 below-knee amputation and 1 above-knee amputation) for a major/minor amputation ratio of 0.06. Ambulatory status was preserved or improved in 74% (67 of 91) of patients. The 30-day readmission rate was 11%, which was lower than that observed (21%) in a contemporaneous but all-inclusive population of lower extremity revascularization procedures performed at our institution. CONCLUSIONS: Multidisciplinary limb salvage teams effectively heal wounds and maintain ambulatory status in patients with limb-threatening neuroischemic wounds. Patient specific factors, such as hindfoot or ankle wounds, can adversely influence the outcome. Even with aggressive care, healing can be prolonged and a substantial proportion of patients can be expected to have a recurrence, making subsequent surveillance mandatory. Our data also suggest that a coordinated amputation prevention program may help to minimize hospital readmissions in this high-risk population.

Clinical outcomes and cost-effectiveness of an externally applied electroceutical device in managing venous leg ulcers in clinical practice in the UK.

OBJECTIVE: To estimate the cost-effectiveness of treating patients with a venous leg ulcer (VLU) with an externally applied electroceutical (EAE) device, plus dressings and compression bandaging or continuing with their previous care plan, from the perspective of the National Health Service (NHS) in the UK. METHOD: This was a prospective, single-arm, non-blinded, clinical and economic evaluation of EAE therapy performed in 2013/14. Patients' VLUs were treated with six active units of EAE therapy (each unit for two days) plus dressings and compression bandaging over a period of 12 days. Afterwards, patients were managed with a combination of dressings and bandages. Each patient acted as their own control so that clinical outcomes, resource use and costs associated with the wound over 12 months before the start of EAE therapy were retrospectively compared with the first 12 months after the start of treatment. The relative cost-effectiveness of EAE therapy was estimated at 2013/14 prices. RESULTS: Within 12 months of starting EAE therapy 77% of all wounds healed and the other 23% improved. This difference in effectiveness between the 12-months period before and after EAE therapy was estimated to yield a 12% improvement in health gain of 0.09 QALYs (p<0.01), a 34% reduction in the requirement for nurse visits (from a mean 50.7 to 33.3 visits per patient) and a 26% reduction in the number of dressings. This resulted in an 11% reduction in the NHS cost of VLU management over 12 months after the start of treatment when compared with the previous 12 months (from £1,981 to £1,754 per patient). Hence, use of EAE therapy was found to be a dominant treatment (i.e. improved outcome for less cost). CONCLUSION: Within the study's limitations, use of the EAE device potentially affords the NHS a cost-effective treatment for managing VLUs when compared with patients remaining on their previous care plan.

A randomized controlled trial of larval therapy for the debridement of leg ulcers: results of a multicenter, randomized, controlled, open, observer blind, parallel group study.

It has been known for centuries that the application of larvae is useful to heal certain wounds by facilitating debridement of necrotic tissue,(1) yet the efficacy of larval therapy continues to be debatable. This study compared the clinical effectiveness of a larval therapy dressing (BioFOAM) with a standard debridement technique (Purilon gel; hydrogel) in terms of time to debridement of venous (VLU) or mixed arterial/venous (MLU) leg ulcers. Data analyses were conducted on 88 subjects. Sixty-four subjects completed the full study. Of these, 31 of the 32 (96.9%) patients who completed treatment in the larvae arm debrided fully, compared with 11 of the 32 (34.4%) patients who completed the hydrogel arm. In addition, 42 (48%) ulcers fully debrided within the 21-day intervention phase, 31 (67.4%) from the larvae arm (n = 46), and 11 (26.2%) from the hydrogel arm (n = 42), which was statistically significant (p = 0.001) in support of larvae. A statistically significant difference was also observed between treatment arms with regard to numbers of dressing changes during the intervention phase of the study (p < 0.001) in that subjects in the larvae arm required significantly fewer dressing changes(mean = 2.83) than those in the hydrogel arm (mean = 5.40). There were no statistically significant differences in the clinical condition of the wound bed and surrounding skin by intervention. Subjects in the larvae arm experienced more ulcer-related pain or discomfort than subjects in the hydrogel arm (p < 0.001). This study provided good evidence to show that larval therapy, in the form of a BioFOAM dressing, debrided VLU and MLU considerably more quickly than a hydrogel, although the possibility of resloughing should be closely monitored.

Cost-effectiveness of three adjunct cellular/tissue-derived products used in the management of chronic venous leg ulcers.

OBJECTIVES: Determine the cost-effectiveness of three topically applied cellular/tissue-derived products (CTPs) used as adjunct therapies to standard care in the management of venous leg ulcers (VLUs). METHODS: A three-state Markov model derived from the medical literature was developed to estimate the comparative cost-effectiveness of three CTPs in relation to VLU standard care. CTPs evaluated in the study included extracellular matrix (ECM), human skin equivalent (HSE), and living skin equivalent (LSE). The three Markov states included unhealed, healed, and death. A 1-year time horizon was used to determine the number of ulcer-free weeks and the expected costs of therapies. The payer perspective was taken in the analysis and only the direct costs of care were considered. Sensitivity analyses were performed to gauge model parameter uncertainty. RESULTS: The expected costs for standard care, ECM, HSE, and LSE VLU therapy were $6,132, $6,732, $10,638, and $11,237, while the expected outcomes were 24, 31, 29, and 27 ulcer-free weeks, respectively. ECM was economically dominant among the three CTPs. In the base case of ECM versus standard care, the incremental cost-effectiveness ratio for ECM therapy was $86 per ulcer-free week. Sensitivity analysis did not alter ECM dominance. Clinic visits and home health utilization exhibited the greatest influence on cost. CONCLUSIONS: ECM is the most cost-effective CTP when used in the management of VLUs as an adjunct to standard care. These findings suggest that VLU standard care therapy with ECM can yield potential cost savings and produce better outcomes than do other CTPs.

Reconciling increasing wound care demands with available resources.

Demographic and epidemiological data suggest that health-care demand will increase considerably in the future as a result of an ageing population and a rise in the prevalence of chronic diseases such as diabetes. This phenomenon has come to be referred to as the 'health care time bomb' in the popular press and political discourse. The authors seek to look beyond the headlines and political rhetoric to clarify the extent to which they reflect the likely future reality with a specific focus on wound management. The present-day burden that wounds and current wound management practices place upon the health-care system are detailed and clarified, and the potential future implications of increasing wound prevalence on the current picture are explored. Possible opportunities to enhance current wound management practice as identified in the analysis are discussed.

Cost-of-illness of leg ulcers in the community.

Leg ulcer management is complex, time-consuming and of high socio-economic importance. Data on cost-of-illness in leg ulcer care are sparse. The objective of this study was to evaluate the cost-of-illness in leg ulcer treatment in the metropolitan area of Hamburg. About 147 institutions involved in wound care participated in a cross-sectional study. Patients consecutively recruited underwent a standardised interview and clinical examination. Main economic outcomes were direct, indirect and intangible costs from a societal perspective. Five hundred and two patients with a mean age of 71 years and mean wound duration of 9 years were enrolled. Annual total costs summed up to a mean of 9060€ /patient/year (8288€ direct, 772€ indirect costs). Direct costs carried by statutory health insurances amounted to 7680€ , patients themselves paid on average 607€. Leg ulcer is associated with high costs for health insurances, patients and the society. Exploratory predictor analyses suggest that early, interprofessional disease-management could lower treatment costs.

A new methodology for costing wound care.

Increasing pressure on health care budgets highlights the need for clinicians to understand the true costs of wound care, in order to be able to defend services against indiscriminate cost cutting. Our aim was to develop and test a straightforward method of measuring treatment costs, which is feasible in routine practice. The method was tested in a prospective study of leg ulcer patients attending three specialist clinics in the UK. A set of ulcer-related health state descriptors were defined on the basis that they represented distinct and clinically relevant descriptions of wound condition ['healed', 'progressing'; 'static''deteriorating; 'severe' (ulcer with serious complications)]. A standardised data-collection instrument was used to record information for all patients attending the clinic during the study period regarding (i) the health state of the ulcer; (ii) treatment received during the clinic visit and (iii) treatment planned between clinic visits. Information on resource use was used to estimate weekly treatment costs by ulcer state. Information was collected at 827 independent weekly observations from the three study centres. Treatment costs increased markedly with ulcer severity: an ulcer which was 'deteriorating' or 'severe' cost between twice and six times as much per week as an ulcer which was progressing normally towards healing. Higher costs were driven primarily by more frequent clinic visits and by the costs of hospitalisation for ulcers with severe complications. This exercise has demonstrated that the proposed methodology is easy to apply, and produces information which is of value in monitoring healing and in potentially reducing treatment costs.

Economic evaluation of a randomized controlled trial of ultrasound therapy for hard-to-heal venous leg ulcers.

BACKGROUND: A pragmatic, multicentre randomized controlled trial (VenUS III) was conducted to determine whether low-dose ultrasound therapy increased the healing rate of hard-to-heal leg ulcers. This study was a cost-effectiveness analysis of the trial data. METHODS: Cost-effectiveness and cost-utility analyses were conducted alongside the VenUS III trial, in which patients were randomly allocated to either ultrasound treatment administered weekly for 12 weeks along with standard care, or standard care alone. The time horizon was 12 months and based on the UK National Health Service (NHS) perspective. RESULTS: The base-case analysis showed that ultrasound therapy added to standard care was likely to be more costly and provide no extra benefit over standard care alone. Individuals who received ultrasound treatment plus standard care took a mean of 14.7 (95 per cent confidence interval - 32.7 to 56.8) days longer to heal, had 0.009 (-0.042 to 0.024) fewer quality-adjusted life years and had higher treatment costs by £ 197.88 (-35.19 to 420.32). Based on these point estimates, ultrasound therapy plus standard care for leg ulcers was dominated by standard care alone. The analysis of uncertainty showed that this treatment strategy is unlikely to be cost-effective. CONCLUSION: Ultrasound treatment was not cost-effective for hard-to-heal leg ulcers and should not be recommended for adoption in the NHS.

Modelling the cost-effectiveness of electric stimulation therapy in non-healing venous leg ulcers.

OBJECTIVE: To estimate the cost-effectiveness of using electric stimulation (ES) therapy (Accel-Heal) plus dressings and compression bandaging compared with dressings and compression bandaging alone in treating chronic, non-healing venous leg ulcers (VLUs) of >6 months' duration from the perspective of the National Health Service (NHS) in the UK. METHOD: A 5-month Markov model was constructed, depicting the management of a chronic, non-healing VLU of >6 months' duration. The model considers the decision by a clinician to continue with a patient's previous care plan (comprising dressings and compression bandaging) or treating with ES therapy plus dressings and compression bandaging. The model was used to estimate the relative cost-effectiveness of ES therapy at 2008-2009 prices. RESULTS: According to the model, 38% of VLUs are expected to heal within 5 months after starting ES therapy, with a further 57% expected to improve. This improvement in clinical outcome is expected to lead to a 6% health gain of 0.017 QALYs (from 0.299 to 0.316 QALYs) over 5 months. The model also showed that using ES therapy instead of continuing with a patient's previous care plan is expected to reduce the NHS cost of managing them by 15%, from £880 to £749, due in part to a 27% reduction in the requirement for nurse visits (from mean 49.0 to 35.9 visits per patient) over the first 5 months after the start of treatment. Hence, use of ES therapy was found to be a dominant treatment (improved outcome for less cost). CONCLUSION: Within the model's limitations, use of ES therapy potentially affords the NHS a cost-effective treatment, compared with patients remaining on their previous care plan in managing chronic, non-healing VLUs of >6 months' duration. However, this is dependant on the number of ES therapy units per treatment, the unit cost of the device, and the number of nurse visits required to manage patients in clinical practice. DECLARATION OF INTEREST: This study was sponsored by Synapse Microcurrent Ltd., manufacturers of Accel-Heal. The authors have no other conflicts of interest that are directly relevant to the content of this manuscript. In particular, Synapse Microcurrent Ltd. had no role in the study design, in the collection, analysis and interpretation of data, or in writing the manuscript.

Lower Extremity Ulcers.

Lower extremity ulcerations contribute to significant morbidity and economic burden globally. Chronic wounds, or those that do not progress through healing in a timely manner, are estimated to affect 6.5 million people in the United States alone causing, significant morbidity and economic burden of at least an estimated $25 billion annually. Owing to the aging population and increasing rates of obesity and diabetes mellitus globally, chronic lower extremity ulcers are predicted to increase. Here, we explore the pathophysiology, diagnosis, and management of the most (and least) commonly seen lower extremity ulcers.

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.