Podiatrist care and outcomes for patients with diabetes and foot ulcer.

We examined whether outcomes of care (amputation and hospitalisation) among patients with diabetes and foot ulcer differ between those who received pre-ulcer care from podiatrists and those who did not. Adult patients with diabetes and a diagnosis of a diabetic foot ulcer were found in the MarketScan Databases, 2005-2008. Multivariate Cox proportional hazard models estimated the hazard of amputation and hospitalisation. Logistic regression estimated the likelihood of these events. Propensity score weighting and regression adjustment were used to adjust for potentially different characteristics of patients who did and did not receive podiatric care. The sample included 27 545 patients aged greater than 65+ years (Medicare-eligible patients with employer-sponsored supplemental insurance) and 20 208 patients aged lesser than 65 years (non Medicare-eligible commercially insured patients). Care by podiatrists in the year prior to a diabetic foot ulcer was associated with a lower hazard of lower extremity amputation, major amputation and hospitalisations in both non Medicare-eligible commercially insured and Medicare-eligible patient populations. Systematic differences between patients with diabetes and foot ulcer, receiving and not receiving care from podiatrists were also observed; specifically, patients with diabetes receiving care from podiatrists tend to be older and sicker.

Total Dystrophic Onychomycosis Successfully Treated with Efinaconazole Topical Solution in Times of Coronavirus Disease of 2019: A Case Study.

Toenail onychomycosis is a common condition that is equally challenging for podiatrists and patients. This case study documents a 26-year-old woman with bilateral total dystrophic onychomycosis of at least 5 years' duration. She had previously failed to respond to treatment with ciclopirox nail lacquer 8% and, despite hiding her condition with nail polish, was suffering from embarrassment, distress, and low self-esteem. At initial consultation, 100% of both great toenails was affected. After discussion of all treatment options, the patient opted for topical efinaconazole 10% solution, once daily for 48 weeks. Significant improvement was noted at the first (4-week) assessment period. This improvement was maintained through each subsequent virtual consultation, and complete cure was seen at a 30-week follow-up visit. To the author's knowledge, this is the first published report on the use of efinaconazole in total dystrophic onychomycosis. It suggests that the product may be effective in patients with even the most severe and treatment-recalcitrant disease, who are unwilling or unable to tolerate systemic antifungal therapy.

Reduced Hospitalizations and Amputations in Patients with Diabetic Foot Ulcers Treated with Cyclical Pressurized Topical Wound Oxygen Therapy: Real-World Outcomes.

Background: This study sought to examine the real-world impact of multimodality cyclical-pressure topical wound oxygen therapy (TWO2) on hospitalizations and amputations in patients with diabetic foot ulcer (DFU) compared with patients without TWO2. Methods: We conducted a retrospective review of deidentified patient medical records at 2 U.S. Veterans Affairs hospitals between January 2012 and January 2020. DFU patients were assigned to TWO2 or NO TWO2 cohorts based on their treatment records. Patients received appropriate standard of care and may have received other advanced wound treatments, including skin substitutes, negative pressure wound therapy, and growth factors. Primary study outcomes were patients requiring hospitalization and/or amputation within 360 days of initial wound documentation. Findings: Among unmatched cohorts of 202 patients with DFU (91 TWO2, 111 NO TWO2), 6.6% and 12.1% of TWO2 patients had hospitalizations and amputations, respectively, compared with 54.1% and 41.4% of NO TWO2 patients within 360 days (p < 0.0001, p < 0.0001), representing 88% and 71% reductions. Among propensity score-matched cohorts of 140 DFU patients (70 TWO2, 70 NO TWO2), compared with NO TWO2, 82% fewer TWO2 patients were hospitalized (7.1% vs. 40.0%, p < 0.0001) and 73% fewer TWO2 patients had amputations (8.6% vs. 31.4%, p = 0.0007). Logistic regression among matched cohorts demonstrated nearly ninefold and fivefold higher risk of hospitalization and amputation, respectively, for NO TWO2 versus TWO2. Interpretation: This retrospective cohort study demonstrates that treating patients with DFU with TWO2 is associated with significant reductions in hospitalizations and amputations in the real-world setting.

A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen (TWO2) Therapy in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study.

OBJECTIVE: Topical oxygen has been used for the treatment of chronic wounds for more than 50 years. Its effectiveness remains disputed due to the limited number of robust high-quality investigations. The aim of this study was to assess the efficacy of multimodality cyclical pressure Topical Wound Oxygen (TWO2) home care therapy in healing refractory diabetic foot ulcers (DFUs) that had failed to heal with standard of care (SOC) alone. RESEARCH DESIGN AND METHODS: Patients with diabetes and chronic DFUs were randomized (double-blind) to either active TWO2 therapy or sham control therapy-both in addition to optimal SOC. The primary outcome was the percentage of ulcers in each group achieving 100% healing at 12 weeks. A group sequential design was used for the study with three predetermined analyses and hard stopping rules once 73, 146, and ultimately 220 patients completed the 12-week treatment phase. RESULTS: At the first analysis point, the active TWO2 arm was found to be superior to the sham arm, with a closure rate of 41.7% compared with 13.5%. This difference in outcome produced an odds ratio (OR) of 4.57 (97.8% CI 1.19, 17.57), P = 0.010. After adjustment for University of Texas Classification (UTC) ulcer grade, the OR increased to 6.00 (97.8% CI 1.44, 24.93), P = 0.004. Cox proportional hazards modeling, also after adjustment for UTC grade, demonstrated >4.5 times the likelihood to heal DFUs over 12 weeks compared with the sham arm with a hazard ratio of 4.66 (97.8% CI 1.36, 15.98), P = 0.004. At 12 months postenrollment, 56% of active arm ulcers were closed compared with 27% of the sham arm ulcers (P = 0.013). CONCLUSIONS: This sham-controlled, double-blind randomized controlled trial demonstrates that, at both 12 weeks and 12 months, adjunctive cyclical pressurized TWO2 therapy was superior in healing chronic DFUs compared with optimal SOC alone.

The Importance of Wound Care Researchers and Manufactures Working with Medical Associations When Bringing New Products to the Marketplace.

Every day products and their accompanying procedures are delivered to the marketplace and touted to aid physicians and other qualified health care professionals (QHPs) in taking care of patients who have chronic wounds. Some of these products/procedures have been developed with the patient in mind and with a serious regulatory and reimbursement strategy, and other products/procedures make physicians, other QHPs, and payers scratch their heads about the true purpose of the product/procedure. Researchers and developers often only focus on gaining Food and Drug Administration (FDA) clearance and often plunge into the marketplace unaware of the reimbursement stumbling blocks that can prevent the expected market acceptance. Researchers and developers should simultaneously plan for FDA clearance and reimbursement from the product's inception. If a product/procedure requires a new procedure code, researchers and manufacturers should seek the help and guidance of professional medical associations to navigate the Current Procedural Terminology (CPT®; CPT is a registered trademark of the American Medical Association), to make available useful new products/procedures for appropriate patients and to adequately reimburse the physician and other QHPs.

Third-party reimbursement for lower-extremity wound care.

This article describes the treatment of lower-extremity wounds, specifically foot and ankle ulcerations, in the context of reimbursement for treatments rendered. Therefore, such issues as standard of care, documentation, classification of foot wounds, coding, and reimbursement are discussed.

The economic value of specialized lower-extremity medical care by podiatric physicians in the treatment of diabetic foot ulcers.

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.