Background: Toenail onychomycosis treatment is challenging, especially in older adults, due to slower nail growth, increased nail thickness, and greater likelihood of concomitant medication use and comorbidities (eg, diabetes, peripheral vascular disease, reduced renal function). Unfortunately, published efficacy and safety data in older adults are limited. Efinaconazole 10% solution has demonstrated efficacy and favorable tolerability in two phase 3 studies and in post hoc analyses of participant sex, ethnicity, age, baseline disease severity, and concurrent diabetes. Here, pooled post hoc analyses were conducted to evaluate efficacy and safety of efinaconazole in participants aged ≥65 years with mild to moderate onychomycosis. Methods: Data were pooled from 2 multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (NCT01008033, NCT01007708) of participants aged 18-70 years with mild to moderate distal lateral subungual onychomycosis affecting ≥1 great toenail. Participants (n=1,655) were randomized (3:1) to topical efinaconazole 10% or vehicle applied once daily for 48 weeks, with a follow-up visit at week 52. Efficacy endpoints included rates of complete cure (0% clinical involvement of target toenail + negative potassium hydroxide [KOH] examination + negative fungal culture), mycologic cure (negative KOH + negative fungal culture), complete/almost complete cure (≤5% clinical involvement + mycologic cure), unaffected new toenail growth (change from baseline in unaffected toenail measurement), and clinical efficacy (<10% clinical involvement) at week 52. Adverse events (AEs) were also assessed. Only participants aged ≥65 years were included in these analyses (n=162 efinaconazole; n=56 vehicle). Results: At week 52, significantly more older adults treated with efinaconazole vs vehicle achieved a complete cure (13.6% vs 3.6%) or a complete/almost complete cure (19.1% vs 5.4%; P<0.05, both). Over half of participants treated with efinaconazole (59.2%) achieved mycologic cure vs 12.5% with vehicle (P<0.001). Least squares mean unaffected new nail growth was significantly greater with efinaconazole vs vehicle (3.9 mm vs 0 mm; P<0.001), and a quarter of participants achieved clinical efficacy with efinaconazole (25.3%) vs 14.3% with vehicle (P<0.05). Most treatment-emergent AEs with efinaconazole were mild to moderate in severity, and discontinuation rates were low (<4.5%), in line with the overall phase 3 populations. Conclusions: Topical efinaconazole 10% solution showed good efficacy and safety in participants aged ≥65 years with mild to moderate onychomycosis, despite possible age-related changes in nail growth. These results were in line with the overall phase 3 populations, demonstrating that efinaconazole is an efficacious treatment for older adults for whom there is a dearth of clinical data. Funding: Ortho Dermatologics

BACKGROUND:Onychomycosis is common in older adults and can be difficult to treat owing to slower nail growth, increased nail thickness, comorbidities, and concomitant medications. Oral treatments can be complicated by contraindications, drug-drug interactions, and adverse effects. Topical treatments such as efinaconazole 10% solution may be beneficial for treating older adults. OBJECTIVES:To evaluate the efficacy/safety of efinaconazole 10% solution in adults aged ≥ 65 years with toenail onychomycosis. PATIENTS/METHODS:In two multicenter, double-blind, phase 3 studies (NCT01008033; NCT01007708), patients with mild to moderate toenail onychomycosis were randomised (3:1) to once-daily efinaconazole or vehicle for 48 weeks, with a 4-week follow-up. Pooled data for participants aged ≥ 65 years were analysed post hoc (n = 162 efinaconazole, n = 56 vehicle). The primary endpoint was complete cure (0% involvement of target toenail plus mycologic cure [negative KOH and fungal culture]) at week 52. Treatment-emergent adverse events (TEAEs) were assessed throughout. RESULTS:At week 52, a significantly greater proportion of older adults (aged 65-71 years) achieved complete cure with efinaconazole than vehicle (13.6% vs. 3.6%; p < 0.05). Complete/almost complete cure rate was also significantly greater (≤ 5% involvement and mycologic cure; 19.1% vs. 5.4%; p = 0.01), and over half (59.2%) of participants achieved mycologic cure with efinaconazole versus 12.5% with vehicle (p < 0.001). Treatment-related TEAE rates with efinaconazole were low (6.0%) and similar to the overall study population. CONCLUSIONS:Efinaconazole 10% solution showed similar efficacy/safety in participants aged ≥ 65 years to the overall phase 3 population, despite potential age-related nail changes. These results demonstrate the benefits of efinaconazole in older patients with onychomycosis.

Background: Topical treatment of toenail onychomycosis may be preferred for patients for whom systemic adverse events, drug-drug interactions, and contraindications associated with oral antifungals are of concern. Three topical antifungals have been approved by the US Food and Drug Administration (FDA) for the treatment of toenail onychomycosis: ciclopirox 8% lacquer, efinaconazole 10% solution, and tavaborole 5% solution. In the absence of head-to-head clinical trials, the objective of this review is to compare in vitro antifungal activity, ex vivo human nail penetration, and clinical efficacy of these topical onychomycosis treatments. Methods: In vitro antifungal activity, defined as the minimum concentration of drug needed to inhibit 90% of fungal growth (MIC90), was assessed for each antifungal against Trichophyton rubrum and T. mentagrophytes, the most common causative fungi in onychomycosis (lower MIC=greater antifungal activity). To assess nail penetration, each antifungal was applied to a human cadaverous toenail; disks punched from the coated nails were placed onto agar plates seeded with clinical isolates of each fungal species. After incubation, antifungal activity was measured as the radius of the area of no fungal growth (zone of inhibition; ZI). Clinical efficacy data were gathered from prescribing information and/or publications of pivotal phase 3 clinical trials, in which each drug was applied daily for 48 weeks (plus debridement with ciclopirox). Outcomes were mycologic cure (negative fungal culture and negative KOH staining), complete/almost complete cure (mycologic cure and ≤5-10% target nail involvement), and complete cure (mycologic cure and 0% target nail involvement). Results: Efinaconazole demonstrated the greatest in vitro antifungal activity against both Trichophyton species. MIC90 values for efinaconazole ranged from 0.008-0.125 mg/mL, compared with 0.25-0.5 mg/mL for ciclopirox and 8 mg/mL for tavaborole. In the ex vivo nail penetration assay, ZIs for efinaconazole (T. rubrum: 82.1 mm; T. mentagrophytes: 63.8 mm) were significantly greater than for ciclopirox and tavaborole (7.4-63.5 mm and 3.6-39.1 mm, respectively; P<0.001, all). Accordingly, efinaconazole demonstrated greater clinical efficacy, with higher rates of mycological cure (53.4-55.2% vs 29.0-36.0% for ciclopirox and tavaborole), complete/almost complete cure (23.4-26.4% vs 6.5-17.9%), and complete cure (15.2-17.8% vs 5.5-9.1%). Conclusions: Among FDA-approved topical therapies approved for the treatment of toenail onychomycosis, efinaconazole 10% solution demonstrated the greatest in vitro antifungal activity, human nail penetration, and clinical efficacy. Funding: Ortho Dermatologics.

Good adherence to treatment is necessary for the successful treatment of onychomycosis and requires that an appropriate amount of medication be prescribed. Most prescriptions for efinaconazole 10% solution, a topical azole antifungal, are for 4 mL per month but there are no data on patient factors or disease characteristics that impact how much medication is needed. Data from two phase 3 studies of efinaconazole 10% solution for the treatment of toenail onychomycosis were pooled and analyzed to determine monthly medication usage based on the number of affected toenails, percent involvement of the target toenail, body mass index (BMI), and sex. Participants with two or more affected nails required, on average, &gt;4 mL of efinaconazole per month, with increasing amounts needed based on the number of nails with onychomycosis (mean: 4.39 mL for 2 nails; 6.36 mL for 6 nails). In contrast, usage was not greatly impacted by target toenail involvement, BMI, or sex. Together, these data indicate that the number of affected nails should be the major consideration when determining the monthly efinaconazole quantity to prescribe. J Drugs Dermatol. 2024;23(2):110-112.&nbsp; &nbsp; doi:10.36849/JDD.7676.

The peer review system has become the standard by which scientific articles are refereed. Unfortunately, even from its beginnings in the mid-1800s it has been fraught with difficulties. Potential reviewers are volunteers who may be inundated with requests to review yet these reviews take considerable time and effort. There is little motivation to complete a review causing significant delays in the publication process. There may be biases unintentionally built into the system between reviewers, authors, editors, and journals. Attempts to overcome these biases by various blinding schemes have been met with limited success. Finally, the recent advent of Artificial Intelligence has the potential to completely upend the system, for good or bad.

Background: Onychomycosis is typically caused by dermatophytes of the species Trichophyton. Topical antifungals must penetrate the nail to reach the infection, though this can be inhibited by keratin binding within the nail. These in vitro experiments compared penetration of commercially available topical antifungals through keratin-free cellulose disks versus human nails to inhibit Trichophyton growth. Methods: Seven topical antifungals were tested: 3 FDA-approved products indicated for the treatment of onychomycosis (ciclopirox 8% lacquer; efinaconazole 10% solution; tavaborole 5% solution) and 4 over-the-counter (OTC) products for fungal infections (tolnaftate 1% solutions [Formula 3, Formula 7, Tolcylen] and undecylenic acid 25% solution [Terpenicol]). Antifungal efficacy was assessed via cellulose disk diffusion assay. Each product was applied to a 6-mm cellulose disk and placed in the center of an agar plate (85 mm radius) seeded with a clinical isolate of T. rubrum or T. mentagrophytes (2 strains each; 3 replicates/strain for each product). After 4-7 days incubation, the zone of inhibition (ZI)—defined as the radius of the area of no fungal growth—was recorded. To assess the impact of nail penetration on antifungal efficacy, products were applied to the tops of human cadaverous great toenails and allowed to dry. Five 4-mm disks were punched from the middle of each nail and placed treated side up on seeded plates prior to measurement of ZI (5 replicates/strain for each product). In both experiments, results were averaged across the 2 strains of each fungal species and untreated nails served as negative controls. Results: Among FDA-approved topicals in the cellulose disk diffusion assay, efinaconazole and tavaborole demonstrated maximal inhibition (ZI=85 mm) against both T. rubrum and T. mentagrophytes; for ciclopirox, average ZIs were lower (59.0 mm; 55.7 mm, respectively). For OTC products, ZIs were 31.2-57.8 mm against T. rubrum and 25.7-47.7 mm against T. mentagrophytes. In the nail penetration assay, average ZI for FDA-approved topicals against both species was greatest for efinaconazole (T. rubrum: 82.1 mm; T. mentagrophytes: 63.8 mm), followed by tavaborole (63.5 mm; 39.1 mm) and ciclopirox (7.4 mm; 3.6 mm). Average ZI of OTC products ranged from 10.5-34.2 mm against both species. ZIs were generally not affected by nail thickness. Conclusions: Our data show that FDA-approved and OTC topical antifungals penetrate cellulose disks more efficiently than cadaver nails, suggesting that keratin in the nails hampers nail penetration. Among all antifungals tested, ability to penetrate human toenails and inhibit growth of both T. rubrum and T. mentagrophytes was greatest for efinaconazole, followed by tavaborole. These results indicate superior transungual penetration of efinaconazole compared to the other antifungals, perhaps due to lower keratin binding in the nail. Funding: Ortho Dermatologics

The peer review system has become the standard by which scientific articles are refereed. Unfortunately, even from its beginnings in the mid-1800s it has been fraught with difficulties. Potential reviewers are volunteers who may be inundated with requests to review yet these reviews take considerable time and effort. There is little motivation to complete a review causing significant delays in the publication process. There may be biases unintentionally built into the system between reviewers, authors, editors, and journals. Attempts to overcome these biases by various blinding schemes have been met with limited success. Finally, the recent advent of Artificial Intelligence has the potential to completely upend the system, for good or bad.

Background: Dermatophytoma, also described as a longitudinal streak/spike, is a form of onychomycosis that presents as yellow/white streaks or patches in the subungual space, with dense fungal masses encased in biofilm. This scoping review of the literature was conducted to address a general lack of information about the epidemiology, pathophysiology, and treatment of dermatophytomas in onychomycosis. Methods: A search was performed in the PubMed and Embase databases for the terms “longitudinal spike” or “dermatophytoma.” Outcomes of interest were definition, prevalence, methods used for diagnosis, treatments, and treatment efficacy. Inclusion and exclusion of search results required agreement between two independent reviewers. Results: Of a total of 51 records, 37 were included. Two reports provided the first unique definitions/clinical features of dermatophytomas. Overall, many descriptions were found, but one conclusive definition was lacking. Prevalence data were limited and inconsistent. The most frequently mentioned diagnostic techniques were clinical assessment, potassium hydroxide/microscopy, and fungal culture/mycology. Oral terbinafine and topical efinaconazole 10% were the most frequently mentioned treatments, followed by topical luliconazole 5% and other oral treatments (itraconazole, fluconazole, fosravuconazole). In studies with five or more patients without nail excision, cure rates were highest with efinaconazole 10%, which ranged from 41% to 100% depending on the clinical and/or mycologic assessment evaluated. Other drugs with greater than or equal to 50% cure rates were topical luliconazole 5% (50%), oral fosravuconazole (57%), and oral terbinafine (67%). In studies that combined oral terbinafine treatment with nail excision using surgical or chemical (40% urea) methods, cure rates ranged from 50% to 100%. Conclusions: There is little published information regarding dermatophytomas in onychomycosis. More clinical research and physician education are needed. Although dermatophytomas have historically been considered difficult to treat, the efficacy data gathered in this scoping review have demonstrated that newer topical treatments are effective, as are oral antifungals in combination with chemical or surgical methods.

A growing body of literature has marked the emergence and spread of antifungal resistance among species of Trichophyton, the most prevalent cause of toenail and fingernail onychomycosis in the United States and Europe. We review published data on rates of oral antifungal resistance among Trichophyton species; causes of antifungal resistance and methods to counteract it; and in vitro data on the role of topical antifungals in the treatment of onychomycosis. Antifungal resistance among species of Trichophyton against terbinafine and itraconazole-the two most common oral treatments for onychomycosis and other superficial fungal infections caused by dermatophytes-has been detected around the globe. Fungal adaptations, patient characteristics (e.g., immunocompromised status; drug-drug interactions), and empirical diagnostic and treatment patterns may contribute to reduced antifungal efficacy and the development of antifungal resistance. Antifungal stewardship efforts aim to ensure proper antifungal use to limit antifungal resistance and improve clinical outcomes. In the treatment of onychomycosis, critical aspects of antifungal stewardship include proper identification of the fungal infection prior to initiation of treatment and improvements in physician and patient education. Topical ciclopirox, efinaconazole and tavaborole, delivered either alone or in combination with oral antifungals, have demonstrated efficacy in vitro against susceptible and/or resistant isolates of Trichophyton species, with low potential for development of antifungal resistance. Additional real-world long-term data are needed to monitor global rates of antifungal resistance and assess the efficacy of oral and topical antifungals, alone or in combination, in counteracting antifungal resistance in the treatment of onychomycosis.

A growing body of literature has marked the emergence and spread of antifungal resistance among species of Trichophyton , the most prevalent cause of toenail and fingernail onychomycosis in the United States and Europe. We review published data on rates of oral antifungal resistance among Trichophyton species; causes of antifungal resistance and methods to counteract it; and in vitro data on the role of topical antifungals in the treatment of onychomycosis. Antifungal resistance among species of Trichophyton against terbinafine and itraconazole—the two most common oral treatments for onychomycosis and other superficial fungal infections caused by dermatophytes—has been detected around the globe. Fungal adaptations, patient characteristics (e.g., immunocompromised status; drug–drug interactions), and empirical diagnostic and treatment patterns may contribute to reduced antifungal efficacy and the development of antifungal resistance. Antifungal stewardship efforts aim to ensure proper antifungal use to limit antifungal resistance and improve clinical outcomes. In the treatment of onychomycosis, critical aspects of antifungal stewardship include proper identification of the fungal infection prior to initiation of treatment and improvements in physician and patient education. Topical ciclopirox, efinaconazole and tavaborole, delivered either alone or in combination with oral antifungals, have demonstrated efficacy in vitro against susceptible and/or resistant isolates of Trichophyton species, with low potential for development of antifungal resistance. Additional real‐world long‐term data are needed to monitor global rates of antifungal resistance and assess the efficacy of oral and topical antifungals, alone or in combination, in counteracting antifungal resistance in the treatment of onychomycosis.

Introduction: In onychomycosis management, excellent treatment adherence is necessary, and requires adequate medication supply. Efinaconazole 10% topical solution is available in 4- or 8-mL bottles; lacking published guidance, 4 mL is most often prescribed. The objective of this analysis was to use clinical data to determine monthly efinaconazole usage by patient demographics and clinical characteristics. Methods: In two identical, double-blind, phase 3 studies, adult participants with mild-to-moderate onychomycosis affecting 20-50% of ≥1 great (target) toenail were randomized 3:1 to once-daily treatment with efinaconazole 10% solution or vehicle for 48 weeks. Bottles of study product were weighed upon dispensation at each study visit (every 4 weeks) and upon return at the following visit. Monthly at-home efinaconazole use was analyzed post hoc based on number of affected toenails, percent involvement of the target toenail, body mass index (BMI), and sex. Results: Efinaconazole-treated participants in both studies (n=656 and 580) had on average 3.7-3.8 affected toenails. Among those with usage data (n=1067), over 55% had ≥4 affected toenails. For the 90% of participants with ≥2 affected nails, average usage ranged from 4.39-6.36 mL/month, corresponding to 1.10-1.59 4-mL bottles; only the 10% of participants with one affected toenail used <4 mL of efinaconazole monthly. Additional subgroup analyses revealed no meaningful differences in efinaconazole usage based on target toenail involvement, BMI, or sex; average medication use was 4.69-5.29 mL/month, corresponding to 1.17-1.32 4-mL bottles monthly. Conclusions: Given that the 4-mL bottle of efinaconazole is most commonly prescribed, patients with onychomycosis of ≥2 toenails will likely run out of medication in under a month. This can lead to gaps in onychomycosis treatment, which may affect medication efficacy and increase likelihood of relapse or reinfection. The number of affected nails should be the major consideration when determining the monthly efinaconazole quantity to prescribe. Funding: Ortho Dermatologics

The coronavirus disease of 2019 pandemic is driving significant change in the health-care system and disrupting the best practices for diabetic limb preservation, leaving large numbers of patients without care. Patients with diabetes and foot ulcers are at increased risk for infections, hospitalization, amputations, and death. Podiatric care is associated with fewer diabetes-related amputations, emergency room visits, hospitalizations, length-of-stay, and costs. However, podiatrists must mobilize and adopt the new paradigm of shifts away from hospital care to community-based care. Implementing the proposed Pandemic Diabetic Foot Triage System, in-home visits, higher acuity office visits, telemedicine, and remote patient monitoring can help podiatrists manage patients while reducing the coronavirus disease of 2019 risk. The goal of podiatrists during the pandemic is to reduce the burden on the health-care system by keeping diabetic foot and wound patients safe, functional, and at home.

Diabetic foot infections (DFIs) are a common and costly complication of diabetes. Soft tissue and bone infections in DFIs frequently lead to amputation and/or sepsis which can be costly for both the patient and the healthcare system. Staphylococcus aureus is the most commonly identified causative agent in DFIs, and people with diabetes may have an increased risk of infection with methicillin-resistant Staphylococcus aureus (MRSA). In addition to increased susceptibility to severe infection, MRSA in DFIs is associated with high rates of treatment failure, morbidity, and hospitalization costs meaning appropriate treatment is a high priority. While hospitalized patients are usually treated with intravenous (IV) vancomycin, this can be costly in terms of inpatient stays, staffing costs, and adverse events. For example, vancomycin-associated acute kidney injury not only delays hospital discharge and increases costs but is also a particular concern for patients with diabetes who already have an increased risk of kidney problems. Vancomycin-resistant strains of S. aureus have also been identified, which means that alternative treatment options may need to be explored. Treatment alternatives to IV vancomycin, including oral antibiotics, have been shown to provide similar efficacy, with reduced costs, outpatient or home-based administration, and with fewer serious adverse effects. Although infectious disease specialists often use IV vancomycin alone, or in combination, as a first-line therapeutic option, they are increasingly seeing the value of outpatient or at-home oral antibiotics as an alternative. This manuscript reviews the evidence for true costs of vancomycin therapy for MRSA-associated DFIs and examines the alternatives.

This editorial accompanies "Diabetes-Related Major and Minor Amputation Risk Increased During the COVID-19 Pandemic," by Dominick J. Casciato, DPM, Sara Yancovitz, DPM, John Thompson, DPM, Steven Anderson, DPM, Alex Bischoff, DPM, Shauna Ayres, MPH, CHES, and Ian Barron, DPM, available at https://doi.org/10.7547/20-224

Onychomycosis (tinea unguium) and tinea pedis are common, frequently concomitant infections of the nails and feet, respectively, and are often caused by dermatophyte fungi (Trichophyton, Microsporum, and Epidermophyton spp.).1 Antifungal-resistant tinea is an emerging global public health problem.2 A recent, large analysis of toenail samples from US patients with suspected onychomycosis found that nearly 4% of Trichophyton spp samples had squalene epoxidase gene mutations, which are associated with terbinafine resistance.3 Clinicians may be increasingly likely to encounter resistant tinea infections. Therefore, we aimed to assess diagnostic approaches, antifungal resistance testing practices, and treatment practices for treatment-resistant onychomycosis and tinea pedis. A 12-question survey was developed in early 2023 by a working group consisting of a dermatologist with expertize in cutaneous fungal infections (BE), an infectious disease clinician (PP), infectious diseases laboratory scientists, epidemiologists, and other experts. The survey instrument was created using QualtricsXM licensed to The Ohio State University (CTJ). The survey was deemed exempt from full review by the university's Institutional Review Board. Informed consent was included as the initial segment of the survey which gave access to the subsequent survey questions when affirmed. This activity was reviewed by CDC and was conducted consistent with applicable federal law and CDC policy (e.g., 45 C.F.R. part 46.102(l)(2), 21 C.F.R. part 56; 42 U.S.C. §241(d); 5 U.S.C. §552a; 44 U.S.C. §3501 et seq.). The survey aimed to query a range of physicians, including podiatrists, who treat dermatophyte infections; the survey was emailed twice to approximately 8000 nonstudent and nonresident American Podiatric Medical Association (APMA) members in February 2023. Other distribution listservs included: dermatologists, the Mycoses Study Group Education and Research Consortium, the FungusCME.org listserv, and social media. SAS (SAS Institute, v. 9.4) was used to produce descriptive statistics. The survey closed on March 31, 2023, with 577 responses. Most responses (n = 498, 86.3%) were from podiatrists, 19 were from primary care practitioners, 23 were from dermatologists, 19 (3.3%) were from infectious diseases physicians, 13 (2.3%) from others, and 5 (0.9%) from pathology/laboratory medicine clinicians. The quantity and completeness of responses from the non-podiatry audiences were low; therefore, we focused on the responses from podiatrists to preserve statistical power. In total, 498 podiatrists began the survey; 200 respondents who did not complete the survey and 1 who did not see patients with dermatophyte infections were excluded from the analysis. Among the 297 included respondents, 106 (36.9%) were from the South; 83 (28.9%) were from the Northeast; 55 (19.2%) were from the Midwest, and 43 (15.0%) were from the West. Most respondents (n = 266, 89.6%) saw > 10 patients with onychomycosis and >10 patients with tinea pedis monthly (n = 171, 57.6%) (Figure 1). The most commonly reported definitions of treatment failure were terbinafine failure (72.4%), failure of multiple topical therapies (71.4%), and infection spreading during treatment (48.1%) (Table 1). Most respondents (53.2%) reported that >20% of onychomycosis cases involve treatment failure; 52.2% reported that <10% of tinea pedis cases involved treatment failure (Figure 2). Cost was a frequently reported (59.6%) barrier to ordering diagnostic testing for dermatophyte infections. The most commonly ordered diagnostic testing included histological examination (81.5%) and molecular testing (59.5%); 21.6% ordered antifungal susceptibility testing, and 30.0% indicated that their laboratory has reported antifungal resistance for treatment failure cases. No regional differences in antifungal resistance were observed (data not shown). For difficult-to-treat or terbinafine-resistant dermatophyte cases, reported management strategies included surgical nail avulsion (59.6%), topical therapy (45.8%), and systemic azole therapy (39.1%) (Figure 3). However, 31.0% reported that some cases remained refractory. Our study demonstrates that antifungal resistant onychomycosis and tinea pedis might be more common than previously appreciated, with nearly one-third of surveyed podiatrists reporting laboratory-confirmed resistance. This proportion might underestimate the true frequency of antifungal resistance because nearly 80% of podiatrists did not routinely order antifungal susceptibility testing. In addition, our study highlights the burden of onychomycosis, as suggested by the high percentage of onychomycosis patients who experience treatment failure, and by the substantial percentage of whom underwent surgical nail avulsion, which is painful and unlikely to be curative. The proportion of podiatrists reporting antifungal resistance in this survey exceeded a 2022 survey in which nearly 20% of 1500 nonspecialist healthcare providers reported clinical experience with antifungal resistant tinea.4 These findings might be attributable to podiatrists ordering diagnostic testing for suspected tinea more frequently than nonspecialists.5 For all clinicians who see patients with tinea, confirmatory laboratory testing is essential for guiding appropriate therapy and avoiding unnecessary antifungal use. Reported treatment failure in this study could be related to several factors besides resistance, including misdiagnosis, patient non-adherence to treatment, or variable definitions of treatment failure. For suspected onychomycosis, the differential is broad, and approximately half of nail disorders seen in clinical practice are not due to fungal pathogens.1 Therefore, the American Academy of Dermatology, as part of the ABIM Foundation's Choosing Wisely campaign, recommends that suspected fungal nail infections be confirmed before starting oral antifungal therapy,6 which we argue should be expanded to include topical antifungals. In addition, inadequate courses of antifungal therapy can lead to treatment failure, particularly for onychomycosis, which requires a long treatment course and can be difficult to completely cure. A treat-to-terminate approach is suggested. The high proportion of laboratory-confirmed antifungal resistance observed could also partly reflect survey response bias in which APMA members who were more familiar with dermatophytes and resistance were more likely to respond to the survey. Other study limitations include that we did not query regarding laboratory-confirmed antifungal resistance for tinea pedis and onychomycosis separately, though tinea pedis almost always precedes onychomycosis. The lack of demographic and training-related information for respondents is another notable limitation. These data could help identify more specific opportunities to address educational gaps in antifungal resistance testing practices. Together with previous studies, our findings suggest that antifungal-resistant tinea is a growing concern. This concern merits increased attention to antifungal stewardship efforts, emphasizing diagnostic testing and judicious antifungal use for suspected superficial fungal infections of the skin and nails. Kaitlin Benedict: Formal analysis; writing—original draft; writing—review and editing. Jeremy A. W. Gold: Conceptualization; methodology; writing—review and editing. Carolynn T. Jones: Conceptualization; methodology; writing—review and editing. Lisa A. Tushla: Conceptualization; methodology; writing—review and editing. Shari R. Lipner: Methodology; writing—review and editing. warren s joseph: writing—review and editing. Dyane E. Tower: Writing—review and editing. Boni Elewski: Conceptualization; methodology; writing—review and editing. Peter G. Pappas: Conceptualization; methodology; supervision; writing—review and editing. This survey was funded in at by a cooperative agreement with the Centers for Disease Control and Prevention (CDC-RFA-CK20-2003) to the University of Alabama at Birmingham and in collaboration with Terranova Medical LLC and The Mycoses Study Group Education and Research Consortium. Shari Lipner has served as a consultant for Ortho-Dermatologics, Moberg Pharmaceuticals, Hoth Therapeutics, and BelleTorus Corporation. Lisa Tushla has received research grant support from Bristol Myers Squibb and Novartis in the area of skin cancer. These financial relationships were not involved with this study. The remaining authors declare no conflict of interest. The lead author Kaitlin Benedict affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained. The data presented in this study are primarily included in this article; however, the full data set and survey instrument may be available on request from the corresponding author.

On January 1, 2020, the Huanan Seafood Wholesale Market in Wuhan, China was closed over worries of a potential outbreak of the SARS (Severe Acute Respiratory Syndrome) virus first detected in 2002.By January 10, the World Health Organization (WHO) reclassified this new infection as being caused by a new virus and classified it as the 2019 Novel Coronavirus (2019-nCoV).This infection began rapidly spreading around the world with the first two cases in the United States being reported by January 20 in Washington State.On March 11, with more than 118,000 cases in 114 countries, the WHO declared COVID-19 a global pandemic. 1Early in March of 2020, Lee Rogers, DPM, JAPMA's Associate Editor for Diabetic Foot contacted me about preparing a manuscript for the Journal outlining the potential disruptions that COVID could potentially cause in the management of diabetic foot infections and the risk that these patients may become at even higher risk for complications including amputation and death.Dr.

The etiology of acute and chronic wounds goes beyond those often reported in the literature, including those with exposed structures, those in which the entire wound bed cannot be visualized, and patients who are not candidates for typical standard of care. Treatment options for these patients may be limited. TABCT is a viable option for these complex wound types and is not hindered by logistical, procedural, or patient factors. A consensus panel of providers with extensive experience in treatment of these wound types was convened to develop consensus recommendations on the use of TABCT in specific complex wound types. Four consensus statements were defined for TABCT use in patients who cannot undergo sharp or extensive debridement, as a protective barrier to prevent further bacterial ingress, in patients with wounds in which the entire wound bed cannot be safely visualized, and in wounds with exposed tendon and/or bone. Consensus panel recommendations show that TABCT application assists in maintenance of a moist wound healing environment, autolytic debridement, recruitment and delivery of factors essential for wound healing, prevention of pathogen entry, and ability to completely fill wound voids that cannot be fully visualized. Additional advantages of TABCT use are its cost-effectiveness, ease of access, minimal related complications, and proven clinical efficacy.

Complex or hard-to-heal wounds can be acute or chronic; the complexity is based on patient-specific local, systemic, and psychosocial factors. Use of autologous tissue can be a significant adjunct to wound closure. Grafts and flaps are the most common autologous tissue used in wound reconstruction. However, patient factors, wound size, and exposed structures may preclude using these methods as primary or even secondary closure techniques. Alternative autologous tissue therapies include those derived from adipose, epidermis or dermis, bone marrow, and blood. Limitations of these treatment modalities include access-related difficulty, cost, creation of a secondary donor site, use of singular or limited cell types, and sparse or contradictory evidence basis of their efficacy of use. A panel of providers experienced in wound care and surgical wound management was convened to create a series of publications on the use of topical autologous blood clot therapy (TABCT) in the treatment of complex wounds. This publication, the first in a series, provides an evidence basis of the gap between definition and treatment of complex wounds, an overview of the use of autologous therapies in these wounds, and the science behind TABCT. The development of a consensus panel for decision pathways and recommendations for TABCT use in specific complex wound types are also discussed. Subsequent articles will provide consensus recommendations on the use of TABCT in full-thickness wounds with exposed tendon and/or bone and undermining or tunneling wounds, in wounds in patients who are nonsurgical candidates, in those who cannot undergo sharp debridement, in patients with arterial wounds who have been maximally revascularized, and in those with transsphincteric anal fistula. This article provides a foundation of knowledge and describes the plan for consensus panel decision pathways and recommendation development of use of TABCT in the treatment of specific complex wound types.

Background: Onychomycosis affects around 14% of individuals in North America and Europe and is undertreated. Treatment is challenging as toenail growth can take 12-18 months, the nail plate may prevent drug penetration, and disease recurrence is common. National guidelines/consensus documents on onychomycosis diagnosis and treatment were last published more than 5 years ago and updated medical guidance is needed. Methods:This document aims to provide recommendations for the diagnosis and pharmaceutical treatment of toenail onychomycosis following a roundtable discussion with a panel of dermatologists, podiatrists, and a microbiologist specializing in nail disease. Results: There was a general consensus on several topics regarding onychomycosis diagnosis, confirmatory laboratory testing, and medications. Onychomycosis should be assessed clinically and confirmed with microscopy, histology, and/or culture. Terbinafine is the primary choice for oral treatment and efinaconazole 10% for topical treatment. Efinaconazole can also be considered for off-label use for maintenance to prevent recurrences. For optimal outcomes, patients should be counseled regarding treatment expectations as well as follow-up care and maintenance post-treatment. Conclusions: This article provides important updates to previous guidelines/consensus documents to assist dermatologists and podiatrists in the diagnosis and treatment of toenail onychomycosis.