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- Author or Editor: Lawrence B. Harkless x
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Ciclopirox 8% Nail Lacquer Topical Solution for the Treatment of Onychomycosis in Patients with Diabetes
A Multicenter, Open-Label Study
Background: An open-label, noncomparative study was conducted to assess the safety and efficacy of ciclopirox 8% nail lacquer topical solution in patients with type 2 diabetes mellitus.
Methods: Forty-nine diabetic patients with distal subungual onychomycosis were treated once daily for 48 weeks with ciclopirox 8% nail lacquer, a topical nail solution approved for the treatment of patients with mild-to-moderate onychomycosis.
Results: Treatment resulted in clinical improvement in 63.4% of patients. Most patients (85.7%) had a mycologic outcome of improvement or cure, with 54.3% attaining mycologic cure. Consideration of mycologic and clinical outcomes generated a treatment outcome of improvement, success, or cure in 84.4% of patients. Moreover, patients experienced improvement in the diseased area of the nail (63.4%), nail surface (56.1%), nail color (48.8%), and nail thickness (65.9%). Ciclopirox 8% nail lacquer was safe, with treatment-related adverse events limited to infection in one patient, which resolved in 15 days; the patient completed the study. No treatment-related serious adverse events were observed.
Conclusion: Ciclopirox 8% nail lacquer is a safe and effective treatment for distal subungual onychomycosis in patients with type 2 diabetes mellitus receiving insulin or oral hypoglycemic therapy. (J Am Podiatr Med Assoc 97(3): 195–202, 2007)
Treatment of Toenail Onychomycosis with Oral Terbinafine Plus Aggressive Debridement
IRON-CLAD, a Large, Randomized, Open-Label, Multicenter Trial
This study was conducted to investigate the efficacy of oral terbinafine with and without aggressive debridement for the treatment of toenail onychomycosis. Onychomycosis patients aged 18 to 75 years received 12 weeks of terbinafine, 250 mg/day, alone (n = 255) or with aggressive debridement (n = 249). Both groups showed marked improvement from baseline at all time points. At week 48, complete, mycologic, and clinical cure rates were higher in the terbinafine plus debridement group compared with the terbinafine alone group, although significance was reached only for clinical cure (59.8% versus 51.4%; P = .023). Although approximately 39% of the patients received at least one antidiabetic, antihypertensive, or cholesterol-lowering agent concomitantly, including statins, the incidence of treatment-emergent adverse events was low and the adverse events were generally mild to moderate in severity. No clinically significant changes in liver transaminase levels were observed 6 weeks after treatment or after 12 weeks in those tested. These results support the well-established safety and efficacy of terbinafine for treatment of onychomycosis. (J Am Podiatr Med Assoc 96(6): 465–473, 2006)
Microvascular dysfunction is an important component of the pathologic processes that occur in diabetic foot disease. The endothelial abnormalities observed in patients with diabetes mellitus are poorly understood, and evidence suggests that endothelial dysfunction could be involved in the pathogenesis of diabetic macroangiopathy and microangiopathy. With the advent of insulin replacement in the early 1900s and increased efforts toward metabolic control of diabetes, long-term complications of this disease have become apparent. These late-term complications are primarily disorders of the vascular system. This article reviews the process of microvascular dysfunction and how it may relate to the pathogenesis of diabetic foot problems. (J Am Podiatr Med Assoc 96(3): 245–252, 2006)
Data from 37 patients who underwent a transmetatarsal amputation from January 1993 to April 1996 were reviewed. The mean age and diabetes duration of the subjects were 54.9 (± 13.2) years and 16.6 (± 8.9) years, respectively. The follow-up period averaged 42.1 (± 11.2) months. At the time of follow-up, 29 (78.4%) of the 37 patients still had foot salvage, 8 (21.6%) had progressed to below-the-knee amputation, and 15 (40.5%) had undergone lower-extremity revascularization. Twelve (80%) of the 15 revascularized patients preserved their transmetatarsal amputation level at a follow-up of 36.4 months. The authors concluded that at a maximum of 3 years follow-up after initial amputation, transmetatarsal amputation was a successful amputation level. (J Am Podiatr Med Assoc 91(10): 533-535, 2001)
Toe and Flow
Essential Components and Structure of the Amputation Prevention Team
At the end of an anatomical peninsula, the foot in diabetes is prone to short- and long-term complications involving neuropathy, vasculopathy, and infection. Effective management requires an interdisciplinary effort focusing on this triad. Herein, we describe the key factors leading to foot complications and the critical skill sets required to assemble a team to care for them. Although specific attention is given to a conjoined model involving podiatric medicine and vascular surgery, the so-called toe and flow model, we further outline three separate programmatic models of care—basic, intermediate, and center of excellence—that can be implemented in the developed and developing world. (J Am Podiatr Med Assoc 100(5): 342–348, 2010)
