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)
In this study of people with diabetes mellitus and peripheral neuropathy, it was found that the feet of patients with a history of hallux ulceration were more pronated and less able to complete a single-leg heel rise compared with the feet of patients with a history of ulceration elsewhere on the foot. The range of active first metatarsophalangeal joint dorsiflexion was found to be significantly lower in the affected foot. Ankle dorsiflexion, subtalar joint range of motion, and angle of gait differed from normal values but were similar to those found in other studies involving diabetic subjects and were not important factors in the occurrence of hallux ulceration. These data indicate that a more pronated foot type is associated with hallux ulceration in diabetic feet. Further studies are required to evaluate the efficacy of footwear and orthoses in altering foot posture to manage hallux ulceration. (J Am Podiatr Med Assoc 96(3): 189–197, 2006)
Toe pressures and the toe brachial index (TBI) represent possible screening tools for peripheral arterial disease; however, limited evidence is available regarding their reliability. The aim of this study was to determine intratester and intertester reliability of toe systolic pressure and the TBI in participants with and without diabetes performed by podiatric physicians.
Two podiatric physicians performed toe and brachial pressure measurements on 80 participants, 40 with and 40 without diabetes, during two testing sessions using photoplethysmography and Doppler probe. Intraclass correlation coefficients (ICCs) and 95% limits of agreement were determined.
In people with diabetes, intratester reliability of toe pressure measurement was excellent for both testers (ICCs, 0.84 and 0.82). Reliability of the TBI was good (ICCs, 0.72 and 0.75) and brachial pressure fair (ICCs, 0.43 and 0.55). The intertester reliability of toe pressure (ICC, 0.82) and the TBI (ICC, 0.80) was excellent. Intertester reliability of brachial pressure was reduced in people with diabetes (ICC, 0.49). In age-matched participants, intratester reliability of toe pressure measurement was excellent for both testers (ICCs, 0.83 and 0.87), and reliability of the TBI (ICCs, 0.74 and 0.80) and brachial pressure (ICCs, 0.73 and 0.78) was good to excellent. Intertester reliability of toe pressure (ICC, 0.84), the TBI (ICC, 0.81), and brachial pressure (ICC, 0.77) was excellent.
Toe pressures and the TBI demonstrated excellent reliability in people with and without diabetes and can be an effective component of lower-extremity vascular screening. However, wide limits of agreement relative to blood pressure values for both cohorts indicate that results should be interpreted with caution.
Metabolic disorders are known to alter the mechanical properties of tendons. We sought to evaluate the prevalence of asymptomatic Achilles tendon enthesopathic changes in patients with type 2 diabetes mellitus (T2DM) without peripheral neuropathy.
We recruited 43 patients with T2DM and 40 controls. Neuropathy was excluded with the Michigan Neuropathy Scoring Instrument. Bilateral ultrasonography of the Achilles tendon enthesis was performed.
Patients with T2DM had a higher prevalence of hypoechogenicity (26.7% versus 2.5%; P = .0001), entheseal thickening (24.4% versus 8.7%; P = .007), and enthesophytes (74.4% versus 57.5%; P = .02). No differences were found in the number of patients with erosions (1.2% versus 0%; P > .99), cortical irregularities (11.6% versus 3.7%; P = .09), bursitis (5.8% versus 3.7%; P = .72), or tears (2.3% versus 1.2%; P > .99). The mean ± SD sum of abnormalities was higher in patients with T2DM (1.5 ± 1.1 versus 0.7 ± 0.6; P < .0001), as was the percentage of bilateral involvement (72.1% versus 45.0%; P = .01). Mean ± SD thickness did not differ between patients and controls (4.4 ± 1.1 mm versus 4.2 ± 0.8 mm; P = .07).
According to our data, there is an elevated prevalence of asymptomatic Achilles tendon enthesopathic changes in patients with T2DM independent of peripheral neuropathy.
A randomized controlled study of 19 patients with diabetes mellitus (10 men, 9 women) was undertaken to determine the effects of home exercise therapy on joint mobility and plantar pressures. Of the 19 subjects, 9 subjects performed unsupervised active and passive range-of-motion exercises of the joints in their feet. Each subject was evaluated for joint stiffness and peak plantar pressures at the beginning and conclusion of the study. After only 1 month of therapy, a statistically significant average decrease of 4.2% in peak plantar pressures was noted in the subjects performing the range-of-motion exercises. In the control group, an average increase of 4.4% in peak plantar pressures was noted. Although the joint mobility data revealed no statistically significant differences between the groups, there was a trend for a decrease in joint stiffness in the treatment group. The results of this study demonstrate that an unsupervised range-of-motion exercise program can reduce peak plantar pressures in the diabetic foot. Given that high plantar pressures have been linked to diabetic neuropathic ulceration, it may be possible to reduce the risk of such ulceration with this therapy. (J Am Podiatr Med Assoc 92(9): 483-490, 2002)
This study evaluated the magnitude and location of activity of diabetic patients at high risk for foot amputation. Twenty subjects aged 64.6 ± 1.8 years with diabetes, neuropathy, deformity, or a history of lower-extremity ulceration or partial foot amputation were dispensed a continuous activity monitor and a log book to record time periods spent in and out of their homes for 1 week. The results indicate that patients took more steps per hour outside their home, but took more steps per day inside their homes. Although 85% of the patients wore their physician-approved shoes most or all of the time while they were outside their homes, only 15% continued to wear them at home. Focusing on protection of the foot during in-home ambulation may be an important factor on which to focus future multidisciplinary efforts to reduce the incidence of ulceration and amputation. The ability to continuously monitor the magnitude, duration, and time of activity ultimately may assist clinicians in dosing activity just as they dose drugs. (J Am Podiatr Med Assoc 91(9): 451-455, 2001)
The authors undertook a study to evaluate the prevalence of ankle equinus and its potential relationship to high plantar pressure in a large, urban population with diabetes mellitus. The first 1,666 consecutive people with diabetes (50.3% male; mean [±SD] age, 69.1 ± 11.1 years) presenting to a large, urban, managed-care outpatient clinic were enrolled in this longitudinal, 2-year outcomes study. Patients received a standardized medical and musculoskeletal assessment at the time of enrollment, including evaluation at an onsite gait laboratory. Equinus was defined as less than 0° of dorsiflexion at the ankle. The overall prevalence of equinus in this population was 10.3%. Patients with equinus had significantly higher peak plantar pressures than those without the deformity and were at nearly three times greater risk for presenting with elevated plantar pressures. There were no significant differences in age, weight, or sex between the two groups. However, patients with equinus had a significantly longer duration of diabetes than those without equinus. Having a high index of suspicion for this deformity and subsequently addressing it through conservative or surgical means may help to reduce the risk of foot ulceration and amputation. (J Am Podiatr Med Assoc 92(9): 479-482, 2002)
Precise comprehensive imaging of arterial circulation is the cornerstone of successful revascularization of the ischemic extremity in patients with diabetes mellitus. Arterial imaging is challenging in these patients because the disease is often multisegmental, with a predilection for the distal tibial and peroneal arteries. Occlusive lesions and the arterial wall itself are often calcified, and patients with ischemic complications frequently have underlying renal insufficiency. Intra-arterial digital subtraction angiography, contrast-enhanced magnetic resonance angiography, and, more recently, computed tomographic angiography have been used as imaging modalities in lower-extremity ischemia. Each modality has specific advantages and shortcomings in this patient population, which are summarized and contrasted in this review. (J Am Podiatr Med Assoc 100(5): 412–423, 2010)
Diabetes-related lower limb amputations (LLAs) are a major complication that can be reduced by employing multidisciplinary center frameworks such as the Toe and Flow model (TFM). In this study, we investigate the LLAs reduction efficacy of the TFM compared to the standard of care (SOC) in the Canadian health-care system.
We retrospectively reviewed the anonymized diabetes-related LLA reports (2007-2017) in Calgary and Edmonton metropolitan health zones in Alberta, Canada. Both zones have the same provincial health-care coverage and similar demographics; however, Calgary operates based on the TFM while Edmonton with the provincial SOC. LLAs were divided into minor and major amputation cohorts and evaluated using the chi-square test, linear regression. A lower major LLAs rate was denoted as a sign for higher efficacy of the system.
Although LLAs numbers remained relatively comparable (Calgary: 2238 and Edmonton: 2410), the Calgary zone had both significantly lower major (45%) and higher minor (42%) amputation incidence rates compared to the Edmonton zone. The increasing trend in minor LLAs and decreasing major LLAs in the Calgary zone were negatively and significantly correlated (r = -0.730, p = 0.011), with no significant correlation in the Edmonton zone.
Calgary's decreasing diabetes-related major LLAs and negative correlation in the minor-major LLAs rates compared to its sister zone Edmonton, provides support for the positive impact of the TFM. This investigation includes support for a modernization of the diabetes-related limb preservation practice in Canada by implementing TFMs across the country to combat major LLAs.
Lower extremity macrovascular disease is more common and progresses more rapidly in the presence of diabetes and has a characteristic peritibial distribution with sparing of the foot arteries. The biology of the diabetic foot is compromised, thereby making it more susceptible to injury. Hence, compromises in perfusion have a greater significance, warranting an aggressive approach to revascularization.