Cost-effectiveness of temperature monitoring to help prevent foot ulcer recurrence in people with diabetes: A multicenter randomized controlled trial.

AIMS: Diabetes-related foot ulcers are common, costly, and frequently recur. Multiple interventions help prevent these ulcers. However, none of these have been prospectively investigated for cost-effectiveness. Our aim was to evaluate the cost-effectiveness of at-home skin temperature monitoring to help prevent diabetes-related foot ulcer recurrence. MATERIALS AND METHODS: Multicenter randomized controlled trial. We randomized 304 persons at high diabetes-related foot ulcer risk to either usual foot care plus daily at-home foot skin temperature monitoring (intervention) or usual care alone (control). Primary outcome was cost-effectiveness based on foot care costs and quality-adjusted life years (QALY) during 18 months follow-up. Foot care costs included costs for ulcer prevention (e.g., footwear, podiatry) and for ulcer treatment when required (e.g., consultation, hospitalisation, amputation). Incremental cost-effectiveness ratios were calculated for intervention versus usual care using probabilistic sensitivity analysis for willingness-to-pay/accept levels up to €100,000. RESULTS: The intervention had a 45% probability of being cost-effective at a willingness-to-accept of €50,000 per QALY lost. This resulted from (non-significantly) lower foot care costs in the intervention group (€6067 vs. €7376; p = 0.45) because of (significantly) fewer participants with ulcer recurrence(s) in 18 months (36% vs. 47%; p = 0.045); however, QALYs were (non-significantly) lower in the intervention group (1.09 vs. 1.12; p = 0.35), especially in those without foot ulcer recurrence (1.09 vs. 1.17; p = 0.10). CONCLUSIONS: At-home skin temperature monitoring for diabetes-related foot ulcer prevention compared with usual care is at best equally cost-effective. The intervention resulted in cost-savings due to preventing foot ulcer recurrence and related costs, but this came at the expense of QALY loss, potentially from self-monitoring burdens.

Randomized Double-blind Cost-effectiveness Comparison of Two 10% Urea Creams in Patients with Diabetic Foot Syndrome.

OBJECTIVE: To evaluate the cost-effectiveness of two 10% urea creams in patients with diabetic foot syndrome. METHODS: This was a prospective, longitudinal, single-center, randomized, double-blind, prospective clinical trial that evaluated the skin quality of 20 feet belonging to 10 patients with diabetic foot syndrome after the application of two 10% urea creams purchased from pharmacies and supermarkets. RESULTS: At follow-up, 19 (95%) of the participants' feet showed improved skin quality, irrespective of the cream applied. On visual inspection, participants had a decreased presence of xerosis, hyperkeratosis, and preulcerative signs such as subkeratotic bruising and areas of redness on the dorsum of the toes. At the 3-month follow-up, nine (90%) of the participants stated that they had continued to apply the cream as a method of self-management to prevent complications. CONCLUSIONS: Creams containing 10% urea purchased in supermarkets improve foot skin quality in patients with diabetic foot syndrome, regardless of their cost. Based on these findings, the authors recommend creams containing 10% urea as a self-management tool for patients with diabetic foot syndrome.

Clinical and economic burden of diabetic foot ulcers: A 5-year longitudinal multi-ethnic cohort study from the tropics.

Diabetic foot ulcers (DFUs) present a substantial clinical and economic burden to healthcare systems around the world, with significant reductions in quality of life for those affected. We aimed to analyse the clinical and economic burden of DFU via a 5-year longitudinal multi-ethnic cohort study. A longitudinal analysis of inpatient and outpatient DFUs data over 5 years from a university tertiary hospital in Singapore was performed. Data included baseline characteristics, clinical outcomes, hospitalisation, and outpatient details. Descriptive statistics, Kaplan-Meier survival analyses, and Cox proportional hazard models were performed. Patients treated for DFUs (n = 1729, mean patient age of 63·4 years) were assessed. The cohort consists of Chinese (61.4%), Malay (13.5%), and Indian (18.4%) patients. Common comorbidities included peripheral arterial disease (74.8%), peripheral neuropathy (14.5%), and a median haemoglobin A1c of 9.9%. Patients underwent toe(s) amputation (36.4%), transmetatarsal amputations (16.9%), or major amputations (6·5%). The mean length of inpatient stay for ulcer-only, minor amputation, and major amputation was 13.3, 20.5, and 59.6 days, respectively. Mean cost per patient-year was US $3368 (ulcer-only), US $10468 (minor amputation), and US $30131 (major amputation). Minor amputation-free survival was 80.9% at 1 year and 56.9% at 5 years, while major amputation-free survival was 97.4% at 1 year and 91.0% at 5 years. In conclusion, within our multi-ethnic cohort of patients from the tropics, there was significant clinical and economic burden of DFUs, with a high wound per patient ratio and escalating healthcare costs corresponding to more proximal amputation levels.

Is Reconstruction of Unstable Midfoot Charcot Neuroarthropathy Cost Effective from a US Payer's Perspective?

BACKGROUND: Charcot neuroarthropathy is a morbid and expensive complication of diabetes that can lead to lower extremity amputation. Current treatment of unstable midfoot deformity includes lifetime limb bracing, primary transtibial amputation, or surgical reconstruction of the deformity. In the absence of a widely adopted treatment algorithm, the decision to pursue more costly attempts at reconstruction in the United States continues to be driven by surgeon preference. QUESTIONS/PURPOSES: To examine the cost effectiveness (defined by lifetime costs, quality-adjusted life-years [QALYs] and incremental cost-effectiveness ratio [ICER]) of surgical reconstruction and its alternatives (primary transtibial amputation and lifetime bracing) for adults with diabetes and unstable midfoot Charcot neuroarthropathy using previously published cost data. METHODS: A Markov model was used to compare Charcot reconstruction and its alternatives in three progressively worsening clinical scenarios: no foot ulcer, uncomplicated (or uninfected) ulcer, and infected ulcer. Our base case scenario was a 50-year-old adult with diabetes and unstable midfoot deformity. Patients were placed into health states based on their disease stage. Transitions between health states occurred annually using probabilities estimated from the evidence obtained after systematic review. The time horizon was 50 cycles. Data regarding costs were obtained from a systematic review. Costs were converted to 2019 USD using the Consumer Price Index. The primary outcomes included the long-term costs and QALYs, which were combined to form ICERs. Willingness-to-pay was set at USD 100,000/QALY. Multiple sensitivity analyses and probabilistic analyses were performed to measure model uncertainty. RESULTS: The most effective strategy for patients without foot ulcers was Charcot reconstruction, which resulted in an additional 1.63 QALYs gained and an ICER of USD 14,340 per QALY gained compared with lifetime bracing. Reconstruction was also the most effective strategy for patients with uninfected foot ulcers, resulting in an additional 1.04 QALYs gained, and an ICER of USD 26,220 per QALY gained compared with bracing. On the other hand, bracing was cost effective in all scenarios and was the only cost-effective strategy for patents with infected foot ulcers; it resulted in 6.32 QALYs gained and an ICER of USD 15,010 per QALY gained compared with transtibial amputation. As unstable midfoot Charcot neuroarthropathy progressed to deep infection, reconstruction lost its value (ICER USD 193,240 per QALY gained) compared with bracing. This was driven by the increasing costs associated with staged surgeries, combined with a higher frequency of complications and shorter patient life expectancies in the infected ulcer cohort. The findings in the no ulcer and uncomplicated ulcer cohorts were both unchanged after multiple sensitivity analyses; however, threshold effects were identified in the infected ulcer cohort during the sensitivity analysis. When the cost of surgery dropped below USD 40,000 or the frequency of postoperative complications dropped below 50%, surgical reconstruction became cost effective. CONCLUSIONS: Surgeons aiming to offer both clinically effective and cost-effective care would do well to discuss surgical reconstruction early with patients who have unstable midfoot Charcot neuroarthropathy, and they should favor lifetime bracing only after deep infection develops. Future clinical studies should focus on methods of minimizing surgical complications and/or reducing operative costs in patients with infected foot ulcers. LEVEL OF EVIDENCE: Level II, economic and decision analysis.

Contribution of 30-day readmissions to the increasing costs of care for the diabetic foot.

OBJECTIVE: The inpatient cost of care for diabetic foot ulcers (DFUs) has been estimated to be $1.4 billion annually in the United States. We have previously demonstrated that the risk of 30-day unplanned readmission for patients with DFU is nearly 22%. Our aim was to quantify the cost of readmissions for patients admitted with DFU. METHODS: All patients presenting to our multidisciplinary diabetic limb preservation service from June 2012 to June 2016 were enrolled in a prospective database. Inpatient costs and net margins were calculated overall and for index admissions vs 30-day unplanned readmissions. RESULTS: A total of 249 admissions for 150 patients were included. Of these, 206 admissions were index admissions and 43 were 30-day readmissions. The most common reason for readmission was the foot wound (49%), followed by a bypass wound (14%), renal complications (9%), and other systemic complications. Surgical interventions during readmission were common (47%) and included both podiatric (37%) and vascular (23%). The wound healing outcomes were favorable, with 78% of all wounds achieving healing by 1 year. Limb salvage was 91% overall. The median hospital cost per admission was $20,111 (interquartile range, $12,589-$33,254) and did not differ between the index and readmissions ($22,165 vs $19,408; P = .46). However, the hospital net margins were lower after readmission ($3908 vs $1975; P = .02). The overall cost of care for patients requiring readmission was significantly greater than that for patients not readmitted ($79,315 vs $28,977; P < .001). During the study period, DFU care at our institution cost $7.9 million, of which $1.2 million (16%) was attributable to readmission costs. CONCLUSIONS: Readmissions for patients with DFU are common and associated with a substantial cost burden. The cost of readmission for patients with DFU was as high as the cost of the index admission but with lower hospital net margins. When extrapolated to national data, the 15% readmission cost burden we have reported would be equivalent to $210 million hospital costs annually. Focused efforts at preventing readmissions in this high-risk patient population are essential to reducing the overall costs of care associated with DFUs.

Quantifying the costs and profitability of care for diabetic foot ulcers treated in a multidisciplinary setting.

OBJECTIVE: Increasing Wound, Ischemia, and foot Infection (WIfI) stage has previously been shown to be associated with prolonged wound healing time, higher number of surgical procedures, and increased cost of care in patients with diabetic foot ulcers (DFUs) treated in a multidisciplinary setting. However, the profitability of this care model is unknown. We aimed to quantify the hospital costs and net margins associated with multidisciplinary DFU care. METHODS: All patients presenting to our multidisciplinary diabetic limb preservation service (January 2012-June 2016) were enrolled in a prospective database. Inpatient and outpatient costs and net margin (U.S. dollars) were calculated for each wound episode (initial visit until complete wound healing) overall and per day of care according to WIfI classification. RESULTS: A total of 319 wound episodes in 248 patients were captured. Patients required an average of 2.6 ± 0.2 inpatient admissions and 0.9 ± 0.1 outpatient procedures to achieve complete healing. Limb salvage at 1 year was 95.0% ± 2.4%. The overall mean cost of care per wound episode was $24,226 ± $2176, including $41,420 ± $3318 for inpatient admissions and $11,265 ± $1038 for outpatient procedures. The mean net margin was $2412 ± $375 per wound episode, including $5128 ± $622 for inpatient admissions and a net loss ($-3730 ± $596) for outpatient procedures. Mean time to wound healing was 136.3 ± 7.9 days, ranging from 106.5 ± 13.1 days for WIfI stage 1 wounds to 229.5 ± 20.0 days for WIfI stage 4 wounds (P < .001). When adjusted for days of care, the net margin ranged from $2.6 ± $1.3 per day (WIfI stage 1) to $23.6 ± $18.8 (WIfI stage 4). CONCLUSIONS: The costs associated with multidisciplinary DFU care are substantial, especially with advanced-stage wounds. Whereas hospitals can operate at a profit overall, the net margins associated with outpatient procedures performed in a hospital-based facility are prohibitive, and the overall net margins are relatively low, given the labor required to achieve good outcomes. Thus, reimbursement for the multidisciplinary care of DFUs should be re-examined.

Multidisciplinary clinics reduce treatment costs and improve patient outcomes in diabetic foot disease.

OBJECTIVE: Diabetic foot disease poses a significant and rising financial burden on health care systems worldwide. This study investigated the effect of a new multidisciplinary diabetic foot clinic (MDDFC) in a large tertiary hospital on patient outcomes and treatment cost. METHODS: Patients' records were retrospectively reviewed to identify all patients who had been managed in a new MDDFC between July 2014 and July 2017. The wound episode-the period from initial presentation to the achievement of a final wound outcome-was identified, and all relevant inpatient and outpatient costs were extracted using a fully absorbed activity-based costing methodology. Risk factor, treatment, outcome, and costing data for this cohort were compared with a group of patients with diabetic foot wounds who had been managed in the same hospital before the advent of the MDDFC using a generalized linear mixed model. RESULTS: The MDDFC and pre-MDDFC cohorts included 73 patients with 80 wound episodes and 225 patients with 265 wound episodes, respectively. Compared with the pre-MDDFC cohort, the MDDFC group had fewer inpatient admissions (1.56 vs 2.64; P ≤ .001). MDDFC patients had a lower major amputation rate (3.8% vs 27.5%; P ≤ .001), a lower mortality rate (7.5% vs 19.2%; P ≤ .05), and a higher rate of minor amputation (53.8% vs 31.7%; P ≤ .01). No statistically significant difference was noted in the rate of excisional débridement, skin graft, and open or endovascular revascularization. In the MDDFC cohort, the median total cost, inpatient cost, and outpatient cost per wound episode was New Zealand dollars (NZD) 22,407.465 (U.S. dollars [USD] 17,253.74), NZD 21,638.93 (USD 16,661.97), and NZD 691.915 (USD 532.77), respectively. The MDDFC to pre-MDDFC wound episode total cost ratio was 0.7586 (P < .001). CONCLUSIONS: This study is the first to compare the cost and treatment outcomes of diabetic foot patients treated in a large tertiary hospital before and after the introduction of an MDDFC. The results show that an MDDFC improves patient outcomes and reduces the cost of treatment. MDDFCs should be adopted as the standard of care for diabetic foot patients.

The cost of diabetic foot ulcers and amputations to the National Health Service in England.

AIM: To estimate the healthcare costs of diabetic foot disease in England. METHODS: Patient-level data sets at a national and local level, and evidence from clinical studies, were used to estimate the annual cost of health care for foot ulceration and amputation in people with diabetes in England in 2014-2015. RESULTS: The cost of health care for ulceration and amputation in diabetes in 2014-2015 is estimated at between £837 million and £962 million; 0.8% to 0.9% of the National Health Service (NHS) budget for England. More than 90% of expenditure was related to ulceration, and 60% was for care in community, outpatient and primary settings. For inpatients, multiple regression analysis suggested that ulceration was associated with a length of stay 8.04 days longer (95% confidence interval 7.65 to 8.42) than that for diabetes admissions without ulceration. CONCLUSIONS: Diabetic foot care accounts for a substantial proportion of healthcare expenditure in England, more than the combined cost of breast, prostate and lung cancers. Much of this expenditure arises through prolonged and severe ulceration. If the NHS were to reduce the prevalence of diabetic foot ulcers in England by one-third, the gross annual saving would be more than £250 million. Diabetic foot ulceration is a large and growing problem globally, and it is likely that there is potential to improve outcomes and reduce expenditure in many countries.

Epidemiology of Peripheral Neuropathy and Lower Extremity Disease in Diabetes.

PURPOSE OF REVIEW: Diabetic peripheral neuropathy eventually affects nearly 50% of adults with diabetes during their lifetime and is associated with substantial morbidity including pain, foot ulcers, and lower limb amputation. This review summarizes the epidemiology, risk factors, and management of diabetic peripheral neuropathy and related lower extremity complications. RECENT FINDINGS: The prevalence of peripheral neuropathy is estimated to be between 6 and 51% among adults with diabetes depending on age, duration of diabetes, glucose control, and type 1 versus type 2 diabetes. The clinical manifestations are variable, ranging from asymptomatic to painful neuropathic symptoms. Because of the risk of foot ulcer (25%) and amputation associated with diabetic peripheral neuropathy, aggressive screening and treatment in the form of glycemic control, regular foot exams, and pain management are important. There is an emerging focus on lifestyle interventions including weight loss and physical activity as well. The American Diabetes Association has issued multiple recommendation statements pertaining to diabetic neuropathies and the care of the diabetic foot. Given that approximately 50% of adults with diabetes will be affected by peripheral neuropathy in their lifetime, more diligent screening and management are important to reduce the complications and health care burden associated with the disease.

Recognizing Common Skin and Soft Tissue Infections in the Nephrology Clinic.

Renal failure patients have an increased risk of infection, including skin and soft tissue infections. This increased susceptibility is multifactorial, due to the conditions causing the renal failure as well as complications of treatment and renal failure's innate effects on patient health. These infections have a significant impact on patient morbidity, increased hospital and procedural demands, and the cost of health care. Many renal failure patients are seen regularly by their nephrology clinic caregivers due to the need for frequent dialysis and transplant monitoring. Familiarity with common skin and soft tissue infections by these caregivers allowing enhanced patient education, optimal infection prevention, and early recognition could significantly reduce the morbidity and cost of these disorders, such as diabetic foot syndrome, necrotizing fasciitis, and herpetic infections.

Methodological approaches for assessing the cost of diabetic foot ulcers: a systematic literature review.

OBJECTIVE: To evaluate the methodological approaches used to assess the cost consequences of diabetic foot ulcers (DFUs) in published scientific papers. METHOD: A systematic literature search was conducted in PubMed, Embase, Scopus, Web of Science and CINAHL. English language papers reporting on the cost of DFUs were identified. Additionally, bibliographies were inspected to identify other relevant cost studies. Following the PRISMA guidance, the review identified the study design, epidemiological approach, analytical perspective and data collection approach in each of the included studies. RESULTS: Relatively few studies of the cost consequences of DFUs were found (n=27). Most studies were conducted in Western countries with only five studies from countries in Asia and Africa. The identified studies used different study designs, epidemiological approaches, data collection strategies, and data sources, which in turn made a systematic comparison of cost estimates difficult. Detailed descriptions of the applied costing method and other methodological aspects were often limited or absent. Many studies only reported costs from a health-care payer's perspective and disregarded the costs to patients, their families and wider society. CONCLUSION: The costs of DFUs have been assessed using a wide range of different methodological approaches often restricted to the healthcare payer's perspective. Therefore, the cost analyses may fail to consider the true societal costs of DFUs.

Health economics for treatment of diabetic foot ulcers: a cost-effectiveness analysis of eight skin substitutes.

AIM: Skin substitutes are frequently used to treat chronic diabetic foot ulcers (DFU), and many different options are available. While the clinical efficacy of many products has been evaluated, a comprehensive cost-effectiveness analysis comparing the most popular skin substitutes and using the most recent cost data has been lacking. METHODS: This study compared eight skin substitutes using published efficacy rates combined with the Centers for Medicare and Medicaid Services (CMS) 2018 cost data. The study criteria resulted in the inclusion of seven studies that described efficacy rates for treatment of DFUs using the skin substitutes. RESULTS: The results revealed wide discrepancies between these skin substitutes for the costs of treatments and healing rates in hospital outpatient departments and physician office settings. Healing rates for 12 and 16 weeks ranged from 28% to 68%, while the average cost for treating one DFU varied from $2001 to $14,507 and $1207 to $8791 in the hospital outpatient department and physician's office setting, respectively. The estimated patient share of costs for treating a single DFU ranged from $400 to $2901 and $241 to $1758 in the hospital outpatient department and physician's office setting, respectively. Most importantly, the estimated number of wounds healed out of 100 DFUs per $1000 expenditure with each patient ranged from 3.9-26.5 DFUs in the hospital outpatient department, and 4.3-36.4 DFUs in the physicians' office setting. CONCLUSIONS: This study revealed that the costs of a skin substitute itself did not necessarily correlate with its healing efficacy. These results provide a comprehensive cost-effectiveness analysis to enable integrated health-care systems, health professionals and reimbursement payers to make informed value decisions when treating DFUs.

The Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system correlates with cost of care for diabetic foot ulcers treated in a multidisciplinary setting.

OBJECTIVE: We have previously demonstrated that the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification correlates with wound healing time in patients with diabetic foot ulcers (DFUs) treated in a multidisciplinary setting. Our aim was to assess whether the charges and costs associated with DFU care increase with higher WIfI stages. METHODS: All patients presenting to our multidisciplinary diabetic limb preservation service from June 2012 to June 2016 were enrolled in a prospective database. Inpatient and outpatient charges, costs, and total revenue from initial visit until complete wound healing were compared for wounds stratified by WIfI classification. RESULTS: A total of 319 wound episodes in 248 patients were captured, including 31% WIfI stage 1, 16% stage 2, 30% stage 3, and 24% stage 4 wounds. Limb salvage at 1 year was 95% ± 2%, and wound healing was achieved in 85% ± 2%. The mean number of overall inpatient admissions (stage 1, 2.07 ± 0.48 vs stage 4, 3.40 ± 0.27; P < .001), procedure-related admissions (stage 1, 1.86 ± 0.45 vs stage 4, 2.28 ± 0.24; P < .001), and inpatient vascular interventions (stage 1, 0.14 ± 0.10 vs stage 4, 0.80 ± 0.12; P < .001) increased significantly with increasing WIfI stage. There were no significant differences in mean number of inpatient podiatric interventions or outpatient procedures between groups (P ≥ .10). The total cost of care per wound episode increased progressively from stage 1 ($3995 ± $1047) to stage 4 ($50,546 ± $4887) wounds (P < .001). Inpatient costs were significantly higher for advanced stage wounds (stage 1, $21,296 ± $4445 vs stage 4, $54,513 ± $5001; P < .001), whereas outpatient procedure costs were not significantly different between groups (P = .72). Overall, hospital total revenue increased with increasing WIfI stage (stage 1, $4182 ± $1185 vs stage 4, $55,790 ± $5540; P < .002). CONCLUSIONS: Increasing WIfI stage is associated with a prolonged wound healing time, a higher number of surgical procedures, and an increased cost of care. While limb salvage outcomes are excellent, the overall cost of DFU care from presentation to healing is substantial, especially for patients with advanced (WIfI stage 3/4) disease treated in a multidisciplinary setting.

Potential cost-effectiveness of using a collagen-containing dressing in managing diabetic foot ulcers in the UK.

OBJECTIVE: To estimate whether a collagen-containing dressing could potentially afford the UK's National Health Service (NHS) a cost-effective intervention for the management of diabetic foot ulcers (DFUs). METHOD: A decision model depicting the management of a DFU was constructed and populated with a combination of published clinical outcomes, resource use estimates and utilities for DFUs. The model estimated the incremental cost-effectiveness of a collagen-containing dressing plus standard care compared with standard care alone over a period of four months in terms of the incremental cost per quality-adjusted life year (QALY) gained. RESULTS: Treatment of DFUs of >6 months duration with a collagen-containing dressing plus standard care instead of standard care alone is expected to increase the probability of healing from 0.08 to 0.53 by four months and increase health-related quality of life at four months from 0.156 to 0.163 QALYs per patient. Additionally, treatment with a collagen-containing dressing has the potential to reduce management costs by 22% over four months when compared with standard care alone (from £2897 to £2255 per patient). Treatment of new DFUs with a collagen-containing dressing plus standard care instead of standard care alone was also found to improve outcomes for less cost. CONCLUSION: Within the study's limitations, use of a collagen-containing dressing plus standard care instead of standard care alone potentially affords the NHS a cost-effective (dominant) treatment for both non-healing and new DFUs, since it improves outcomes for less cost. Hence, protocols should be established which enable clinicians to effectively introduce collagen-containing dressings into care pathways and monitor response to treatment.

Increasing productivity with smartphone digital imagery wound measurements and analysis.

OBJECTIVE: The primary aim was to determine the productivity increase using digital imagery for better documentation and analysis. A case series was done in a specialised care centre with patients managed with advanced dressings and using state-of-the-art smartphone technology for documentation to save costs and time. METHOD: Wounds were cleansed and debrided before using the application to photograph, document, measure and analyse the wounds. The smartphone app was oriented parallel to the plane of the wound, where possible, to obtain accurate measurements. A longitudinal study report was generated for each wound and showed the progress of the wound healing until the wound was closed. RESULTS: A sample size of 60 patients consisting of wounds from different locations, and a total of 203 measurements and analyses were conducted over a period of seven months. The wound monitoring app proved to be effective for wound monitoring and required less than two hours' training. A report summary of wounds recorded could also be generated automatically through the dashboard. All 60 patients' cases were automatically recorded, measured and presented into reports for use in clinical analysis. There was a significant time savings (27 hours per day for a specialised care centre with 10 nurses) increase over manual wound documentation and measuring methods. CONCLUSION: The app provided a non-contact, easy to use, reliable and accurate smart wound management solution for clinicians and physicians to track wound healing in patients. The app could also be used by patients and caregivers for home monitoring of their wounds.

Diabetic foot 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 diabetic foot ulcers (DFUs) 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 130 patients with a newly diagnosed DFU 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. Patients were predominantly managed in the community by nurses, with minimal clinical involvement of specialist physicians. 5% of patients saw a podiatrist, and 5% received a pressure-offloading device. Additionally, 17% of patients had at least one amputation within the first 12 months from initial presentation of their DFU. 14% of DFUs were documented as being clinically infected at initial presentation, although an additional 31% of patients were prescribed an antimicrobial dressing at the time of presentation. Of all the DFUs, 35% healed within 12 months, and the mean time to healing was 4·4 months. Over the study period, 48% of all patients received at least one prescription for a compression system, but significantly more patients healed if they never received compression (67% versus 16%; P < 0·001). The mean NHS cost of wound care over 12 months was an estimated £7800 per DFU (of which 13% was attributable to amputations), ranging from £2140 to £8800 per healed and unhealed DFU, respectively, and £16 900 per amputated wound. Consolidated medical records from a primary care held database provided 'real-world evidence' highlighting the consequences of inefficient and inadequate management of DFUs in clinical practice in the UK. Clinical and economic benefits to both patients and the NHS could accrue from strategies that focus on (i) wound prevention, (ii) improving wound-healing rates and (iii) reducing infection and amputation rates.

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.

Cost-effectiveness of using adjunctive porcine small intestine submucosa tri-layer matrix compared with standard care in managing diabetic foot ulcers in the US.

OBJECTIVE: To estimate the cost-effectiveness of using tri-layer porcine small intestine submucosa (SIS; Oasis Ultra) as an adjunct to standard care compared with standard care alone in managing diabetic foot ulcers (DFUs) in the US, from the perspective of Medicare. METHOD: A Markov model was constructed to simulate the management of diabetic neuropathic lower extremity ulcers over a period of one year in the US. The model was used to estimate the cost-effectiveness of initially using adjunctive SIS compared with standard care alone to treat a DFU in the US at 2016 prices. RESULTS: At 12 months after the start of treatment, the use of adjunctive SIS instead of standard care alone is expected to lead to a 42 % increase in the number of ulcer-free months, 32 % increase in the probability of healing, a 3 % decrease in the probability of developing complicated ulcers and a 1 % decrease in the probability of undergoing an amputation. Health-care resource use is expected to be reduced by 11-14 % among patients who are initially managed with adjunctive SIS compared with those initially managed with standard care alone, with the exception of debridement, which is expected to be reduced by 35 %. Hence, the total health-care cost of starting treatment with adjunctive SIS instead of standard care alone was estimated to reduce payer costs by 1% (i.e. $105 per patient) over 12 months following the start of treatment. CONCLUSION: Within the study's limitations, the use of adjunctive SIS instead of standard care alone improves outcome for less cost and thereby affords a cost-effective use of Medicare-funded resources in the management of neuropathic foot ulcers among adult patients with type 1 or 2 diabetes mellitus in the US.

A cost-effectiveness analysis of optimal care for diabetic foot ulcers in Australia.

In addition to affecting quality of life, diabetic foot ulcers (DFUs) impose an economic burden on both patients and the health system. This study developed a Markov model to analyse the cost-effectiveness of implementing optimal care in comparison with the continuation of usual care for diabetic patients at high risk of DFUs in the Australian setting. The model results demonstrated overall 5-year cost savings (AUD 9100·11 for those aged 35-54, $9391·60 for those aged 55-74 and $12 394·97 for those aged 75 or older) and improved health benefits measured in quality-adjusted life years (QALYs) (0·13 QALYs, 0·13 QALYs and 0·16 QALYs, respectively) for high-risk patients receiving optimal care for DFUs compared with usual care. Total cost savings for Australia were estimated at AUD 2·7 billion over 5 years. Probabilistic sensitivity analysis showed that optimal care always had a higher probability of costing less and generating more health benefits. This study provides important evidence to inform Australian policy decisions on the efficient use of health resources and supports the implementation of evidence-based optimal care in Australia. Furthermore, this information is of great importance for comparable developed countries that could reap similar benefits from investing in these well-known evidence-based strategies.

A prospective, randomised, controlled, multicentre clinical trial examining healing rates, safety and cost to closure of an acellular reticular allogenic human dermis versus standard of care in the treatment of chronic diabetic foot ulcers.

Acellular dermal matrices can successfully heal wounds. This study's goal was to compare clinical outcomes of a novel, open-structure human reticular acellular dermis matrix (HR-ADM) to facilitate wound closure in non-healing diabetic foot ulcers (DFUs) versus DFUs treated with standard of care (SOC). Following a 2-week screening period in which DFUs were treated with offloading and moist wound care, patients were randomised to either SOC alone or HR-ADM plus SOC applied weekly for up to 12 weeks. At 6 weeks, the primary outcome time, 65% of the HR-ADM-treated DFUs healed (13/20) compared with 5% (1/20) of DFUs that received SOC alone. At 12 weeks, the proportions of DFUs healed were 80% and 20%, respectively. Mean time to heal within 12 weeks was 40 days for the HR-ADM group compared with 77 days for the SOC group. There was no incidence of increased adverse or serious adverse events between groups or any adverse events related to the graft. Mean and median graft costs to closure per healed wound in the HR-ADM group were $1475 and $963, respectively. Weekly application of HR-ADM is an effective intervention for promoting closure of non-healing DFUs.