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)
Although an increased prevalence of plantar verrucae has been associated with human immunodeficiency virus (HIV) infection, human papillomavirus (HPV) typing studies have not been published about this patient population. We sought to determine the prevalence of HPV types in plantar verrucae of HIV-positive (HIV+) and HIV-negative (HIV–) individuals.
Thirty-nine plantar verruca lesions in 17 individuals were examined. Nine participants were HIV+ and eight were HIV–. Detection of HPV was performed by polymerase chain reaction using two sets of primers: MY09/MY11. The type of HPV was determined by hybridization to 38 different HPV types. Clinical types of verrucae were correlated to the HPV strain identified in each lesion.
Of the 39 plantar verruca samples, 38 typed to HPV-2, HPV-27, and HPV-57 strains in HIV+ and HIV– individuals. Specifically, a large proportion of the samples from HIV– individuals typed as HPV-27 (87.5%), and HPV-2 was the predominant type identified in HIV+ individuals (50%). No rare or atypical HPV types were found in either group. We identified HPV-2 and HPV-27 in 96% of verruca plantaris clinical type. Mosaic warts typed to HPV-27 and HPV-57, and 80% of punctate verrucae typed to HPV-57.
This study presents an increased prevalence of HPV-2, HPV-27, and HPV-57 in plantar verrucae in this study population and provides insight into the occurrence of these types in HIV+ and HIV– individuals.
Malignant melanoma with osteocartilaginous differentiation is extremely rare. We report a case of periungual osteocartilaginous melanoma (OCM) on the right hallux. A 59-year-old man presented with a rapidly growing mass with drainage on his right great toe after treatment of ingrown toenail and infection 3 months earlier. Physical examination showed a 2.0×1.5×1.0-cm, malodorous, erythematous, dusky, granuloma-like mass along the fibular border of the right hallux. Pathologic evaluation of the excisional biopsy revealed diffuse epithelioid and chondroblastoma-like melanocytes with atypia and pleomorphism in the dermis with strong SOX10 immunostaining. The lesion was diagnosed as osteocartilaginous melanoma. The patient was referred to a surgical oncologist for further treatment. Osteocartilaginous melanoma is a rare variant of malignant melanoma that needs to be differentiated from chondroblastoma and other lesions. Immunostains for SOX10, H3K36M, and SATB2 are helpful for the differential diagnosis.
Despite advancements in the treatment of diabetic patients with “at-risk” limbs, minor and major amputations remain commonplace. The diabetic population is especially prone to surgical complications from lower extremity amputation because of comorbidities such as renal disease, hypertension, hyperlipidemia, microvascular and macrovascular disease, and peripheral neuropathy. Complication occurrence may result in increases in hospital stay duration, unplanned readmission rate, mortality rate, number of operations, and incidence of infection. Skin flap necrosis and wound healing delay secondary to inadequate perfusion of soft tissues continues to result in significant morbidity, mortality, and cost to individuals and the health-care system. Intraoperative indocyanine green fluorescent angiography for the assessment of tissue perfusion may be used to assess tissue perfusion in this patient population to minimize complications associated with amputations. This technology provides real-time functional assessment of the macrovascular and microvascular systems in addition to arterial and venous flow to and from the flap soft tissues. This case study explores the use of indocyanine green fluorescent angiography for the treatment of a diabetic patient with a large dorsal and plantar soft-tissue deficit and need for transmetatarsal amputation with nontraditional rotational flap coverage. The authors theorize that the use of indocyanine green may decrease postoperative complications and cost to the health-care system through fewer readmissions and fewer procedures.
Advancements in methods of imaging infection have surpassed their worth. Although scientifically substantiated, their clinical pertinence is frequently disappointing. Diabetic infections, postoperative or traumatic sequelae, rheumatologic conditions, and Charcot disease are difficult to differentiate from osseous infection because they all manifest as inflammation. As this country struggles to contain health care costs, a critical investigation regarding the practical benefits of imaging osteomyelitis in the foot is overdue.
Although Kirschner wire implantation is popular for treating toe deformities, complications frequently occur. To prevent pin-tract infection and difficult Kirschner wire extraction, several implants have been developed to improve treatment outcomes.
Patients who had undergone an interphalangeal fusion by two-component implant for the treatment of toe deformities were included. Thirty-one toes of 21 patients were evaluated retrospectively. American Orthopaedic Foot and Ankle Society (AOFAS) forefoot scores were used in clinical evaluation.
The mean operation duration per toe was 16.4 min (range, 13–26 min). The average AOFAS forefoot score was 42.76 (range, 23–57) preoperatively and 88.76 (range, 70–95) at 34.4 months (range, 26–46 months) after surgery. Mean follow-up was 14.8 months (range, 12–19 months). Compared with before surgery, the AOFAS score was increased significantly after surgery (P = .03 by t test). Three minor complications were encountered. In one patient an infection was observed. After the implants were removed (first month) she was treated successfully by debridement and antibiotic agents and, finally, Kirschner wire placement. The second patient had a fissure fracture at the proximal phalanx, but routine follow-up did not change. In the third patient, the locking mechanism had become loose (detected on day 1 radiography); it was remounted under fluoroscopy without opening the wound. No patients had a cutout, loss of alignment, recurrence, or persistent swelling.
Outcomes of arthrodesis using the two-component implant were found to be safe and reliable, especially for hammer toe and fifth toe deformities.
Background: We sought to evaluate clinicians’ compliance with national guidelines for tetanus vaccination prophylaxis in patients with high-risk feet.
Methods: We retrospectively evaluated 114 consecutive patients between June 1, 2011, and March 31, 2019, who presented to the emergency department with a foot infection resulting from a puncture injury. Eighty-three patients had diabetes mellitus and 31 patients did not have diabetes mellitus. Electronic medical records were used to collect a broad range of study data on patient demographics, medical history, tetanus immunization history and tetanus status on presentation to the emergency department, peripheral arterial disease, sensory neuropathy, laboratory values, and clinical/surgical outcomes.
Results: Of the 114 patients who presented to the emergency department with a puncture wound, 53 (46.5%) did not have up-to-date tetanus immunization. Of those patients, 79.2% received a tetanus-containing vaccine booster, 3.8% received intramuscular tetanus immunoglobulin, 3.8% received both a tetanus-containing vaccine booster and tetanus immunoglobulins, and 20.8% received no form of tetanus prophylaxis. Comparing data between patients with and without diabetes mellitus, there were no statistically significant differences in tetanus prophylaxis.
Conclusions: Guidelines for tetanus prophylaxis among high-risk podiatric medical patients in this study center are not followed in all patients. Patients with diabetes mellitus are at high risk for exposure to tetanus; therefore, we recommend that physicians take a detailed tetanus immunization history and vaccinate patients if the tetanus history is unclear.
Recently, there has been a resurgence of interest in potential phototherapy technologies for the local treatment of bacterial and fungal infection. Currently, onychomycosis is the principle disease that is the target of these phototherapies in podiatric medicine. Some of these technologies are currently undergoing in vitro and in vivo trials approved by institutional review boards. The three light-based technologies are ultraviolet light therapy, near infrared photo-inactivation therapy, and photothermal ablative antisepsis. Each of these technologies have markedly dissimilar mechanisms of action. In this review, each technology will be discussed from the perspectives of history, photobiology, individual mechanism of action, safety, and potential clinical efficacy, with data presented from published material. This review is intended to give podiatric physicians detailed information on state-of-the-art infectious disease phototherapy. (J Am Podiatr Med Assoc 99(4): 348–352, 2009)
Partial foot amputations (PFAs) are often indicated for the treatment of severe infection, osteomyelitis, and critical limb ischemia, which consequently leads to irreversible necrosis. Many patients who undergo PFAs have concomitant comorbidities and generally present with a severe acute manifestation of the condition, such as gangrenous changes, systemic infection, or debilitating pain, which would then require emergency amputation on an inpatient basis.
The purpose of this study was to track the recent prevalence of PFAs and to investigate the current demographic trends of the physicians managing and performing PFAs, specifically regarding medical degree and specialty. Doctors of podiatric medicine are striving to achieve parity with their allopathic and osteopathic surgical counterparts and become a more prominent part of the multidisciplinary approach to limb salvage and emergency surgical treatment. This study evaluated 4 years (2009–2012) of PFA data from the Pennsylvania state inpatient database in the two most populated areas of Pennsylvania: Philadelphia and Allegheny counties. Statistics on medical schools were obtained directly from the accrediting bodies of allopathic, osteopathic, and podiatric medical schools. The goal of this study was to evaluate the general trends of patients undergoing a PFA and to quantify the upswing of podiatric surgeons intervening in the surgical care of these patients.
The number of partial foot amputations in the United States rose from 2006 to 2012. Podiatric surgeons performed 46% of theses procedures for residents of Philadelphia County from 2009 to 2012. In Allegheny County podiatric physicians performed 42% of these procedures during the same time frame.
Partial foot amputations are increasing over time. Podiatric Surgeons perform a significant share of these operations. This share is increasing in the most populated areas of Pennsylvania.
Studies have shown that lower-extremity problems in the homeless population have significant public health and economic implications. A combined community service and research project was performed to identify and address the foot and ankle care needs in a sample homeless population in San Francisco, California.
A 37-question survey regarding general demographic characteristics, foot hygiene practices, associated risk factors, and self-reported lower-extremity pathologic conditions was completed by 299 homeless individuals who met the inclusion criteria. The service project included education on proper foot care and the distribution of footwear.
The participants demonstrated mostly good efforts regarding foot hygiene but had high-risk factors, including smoking, alcohol use, and extended hours on their feet. More than half of the homeless individuals surveyed experienced foot pain. Approximately one in five had edema and neuropathic symptoms. The most commonly reported foot problems were dermatologic, but these conditions could pose serious sequelae in the setting of risk factors. The community service project was well received by the homeless community.
This study demonstrates lack of resources and high-risk factors for lower-extremity complications in the homeless individuals studied. It is important in the realm of public health to keep lower-extremity health in mind because it plays an important role in preventing the spread of infection and lowering the social economic burden.