We conducted a post-hoc retrospective analysis of patients enrolled in a randomized controlled trial to evaluate overall costs of negative pressure wound therapy (NPWT; V.A.C. Therapy; KCI USA, Inc, San Antonio, Texas) versus advanced moist wound therapy (AMWT) in treating grade 2 and 3 diabetic foot wounds during a 12-week therapy course.
Data from two study arms (NPWT [n = 169] or AMWT [n = 166]) originating from Protocol VAC2001-08 were collected from patient records and used as the basis of the calculations performed in our cost analysis.
A total of 324 patient records (NPWT = 162; AMWT = 162) were analyzed. There was a median wound area reduction of 85.0% from baseline in patients treated with NPWT compared to a 61.8% reduction in those treated with AMWT. The total cost for all patients, regardless of closure, was $1,941,472.07 in the NPWT group compared to $2,196,315.86 in the AMWT group. In patients who achieved complete wound closure, the mean cost per patient in the NPWT group was $10,172 compared to $9,505 in the AMWT group; the median cost per 1 cm2 of closure was $1,227 with NPWT and $1,695 with AMWT. In patients who did not achieve complete wound closure, the mean total wound care cost per patient in the NPWT group was $13,262, compared to $15,069 in the AMWT group. The median cost to close 1 cm2 in wounds that didn't heal using NPWT was $1,633, compared to $2,927 with AMWT.
Our results show greater cost effectiveness with NPWT versus AMWT in recalcitrant wounds that didn't close during a 12-week period, due to lower expenditures on procedures and use of health-care resources.
Integra bilayer wound matrix (IBWM) is a bilayer skin replacement system composed of a dermal regeneration layer and a temporary epidermal layer. It is used to treat various types of deep, large wounds via an inpatient procedure in an operating room. We sought to determine ease of use and effectiveness of IBWM in an outpatient clinical setting when treating diabetic foot ulcers. In addition, no epidermal autografting was performed in conjunction with the IBWM after silicone release, as is common in the inpatient setting.
This 12-week, single-arm, prospective pilot study was conducted in three outpatient clinics. Weekly evaluations included monitoring the wound for signs of infection during the 12-week follow-up phase.
Eleven patients with diabetic foot ulcers who met the inclusion and exclusion criteria were enrolled. One patient was discontinued from the study owing to noncompliance leading to a serious adverse event. Therefore, ten patients who received the study intervention were included in the per-protocol population reported herein. The mean patient age was 60.6 years, with an average 11-year history of diabetes mellitus. Each ulcer was located on the plantar aspect of the foot. No infection was reported during the study. Patients treated with IBWM showed progressive wound healing over time: the greatest mean wound reduction was approximately 95% in week 12. Seven of ten patients (70%) achieved complete wound closure by week 12. No recurrent ulcers were reported during follow-up.
These results are consistent with the hypothesis that IBWM is easy to use, safe, and effective when used on diabetic foot ulcers in an outpatient clinical setting without the secondary procedure of autografting for closure. (J Am Podiatr Med Assoc 103(4): 274–280, 2013)
In 2007, the treatment of diabetes and its complications in the United States generated at least $116 billion in direct costs; at least 33% of these costs were linked to the treatment of foot ulcers. Although the team approach to diabetic foot problems is effective in preventing lower-extremity amputations, the costs associated with implementing a diabetic-foot–care team are not well understood. An analysis of these costs provides the basis for this report.
Diabetic foot problems impose a major economic burden, and costs increase disproportionately to the severity of the condition. Compared with diabetic patients without foot ulcers, the cost of care for those with foot ulcers is 5.4 times higher in the year after the first ulcer episode and 2.8 times higher in the second year. Costs for treating the highest-grade ulcers are 8 times higher than are those for treating low-grade ulcers. Patients with diabetic foot ulcers require more frequent emergency department visits and are more commonly admitted to the hospital, requiring longer lengths of stay. Implementation of the team approach to manage diabetic foot ulcers in a given region or health-care system has been reported to reduce long-term amputation rates 62% to 82%. Limb salvage efforts may include aggressive therapy such as revascularization procedures and advanced wound-healing modalities. Although these procedures are costly, the team approach gradually leads to improved screening and prevention programs and earlier interventions and, thus, seems to reduce long-term costs.
To date, aggressive limb preservation management for patients with diabetic foot ulcers has not usually been paired with adequate reimbursement. It is essential to direct efforts in patient-caregiver education to allow early recognition and management of all diabetic foot problems and to build integrated pathways of care that facilitate timely access to limb salvage procedures. Increasing evidence suggests that the costs of implementing diabetic foot teams can be offset in the long term by improved access to care and reductions in foot complications and amputation rates. (J Am Podiatr Med Assoc 100(5): 335–341, 2010)
Background: We used a model of lower-extremity ulceration to determine the impact of a podiatric lead limb preservation team on identified relationships among risk factors, predictors of ulceration, amputation, and clinical outcomes of lower-extremity disease in patients with diabetes mellitus.
Methods: A total of 485 patients with diabetes mellitus were randomly selected from the diabetic population and included in this retrospective cohort study. Patients were then stratified into two groups: those who received specialty podiatric medical care and those who did not. Data covering a 5-year period were collected using electronic medical records and chart abstraction to capture detailed treatment characteristics, ulcer status, and surgical outcomes.
Results: Overall, the frequencies of inpatient and outpatient encounters and the durations of hospital stays were significantly greater with increasing wound depth and in the presence of infection. In addition, the overall ulcer incidence was greater in patients with callus (34.3% versus 10.3%, P < .0001) with and without neuropathy (20.4% and 4.1%, P < .0001). Among patients treated in a specialty multidiscipline podiatric medical setting, the proportion of all amputations that were “minor” was significantly increased (33.7% versus 67.3%, P = .0006), and survival was significantly improved (19.5% versus 7.7%, P < .0001).
Conclusions: Early identification of individuals at increased risk for lower-extremity ulceration and subsequent referral for advanced multidiscipline podiatric medical specialty care may decrease rates of ulceration and proximal amputation and improve survival in patients with diabetes mellitus who are at high risk for ulceration and limb loss. (J Am Podiatr Med Assoc 100(4): 235–241, 2010)
Background: We sought to examine the economic value of specialized lower-extremity medical care by podiatric physicians in the treatment of diabetic foot ulcers by evaluating cost outcomes for patients with diabetic foot ulcer who did and did not receive care from a podiatric physician in the year before the onset of a foot ulcer.
Methods: We analyzed the economic value among commercially insured patients and Medicare-eligible patients with employer-sponsored supplemental medical benefits using the MarketScan Databases. The analysis consisted of two parts. In part I, we examined cost or savings per patient associated with care by podiatric physicians using propensity score matching and regression techniques; in part II, we extrapolated cost or savings to populations.
Results: Matched and regression-adjusted results indicated that patients who visited a podiatric physician had $13,474 lower costs in commercial plans and $3,624 lower costs in Medicare plans during 2-year follow-up (P < .01 for both). A positive net present value of increasing the share of patients at risk for diabetic foot ulcer by 1% was found, with a range of $1.2 to $17.7 million for employer-sponsored plans and $1.0 to $12.7 million for Medicare plans.
Conclusions: These findings suggest that podiatric medical care can reduce the disease and economic burdens of diabetes. (J Am Podiatr Med Assoc 101(2): 93–115, 2011)