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Can the use of a topical antifungal nail lacquer reduce risk for diabetic foot ulceration? Results from a randomised controlled pilot study. Int Wound J. 2005 Jun;2(2):166-70
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The purpose of this study was to determine whether the routine use of a topical antifungal nail lacquer (AFL) could reduce the risk for ulceration by theoretically increasing the frequency of patient self-inspection. In this randomised controlled trial, 70 persons at high risk for diabetic foot ulceration were enrolled into a preventative care program involving daily self-inspection with the possible use of an AFL (ciclopirox 8%) versus self-inspection instructions alone (NAFL). Patients were followed for 12 months or until ulceration. Using an intent to treat analysis, there was no significant difference in proportion of persons ulcerating in the AFL versus the NAFL groups (5.9% versus 5.6% P = 0.9). There was also no difference in the number of unexpected visits (P = 0.2) or missed appointments (P = 0.7) between treatment arms. Interestingly, while there was no difference in proportion of patients with clinically diagnosed hyperkeratosis or tinea pedis on entry into the study (P = 0.2), a significantly lower proportion of AFL patients had a clinical diagnosis on study termination (52.9% versus 77.8% P = 0.03, OR = 1.7, 95% confidence interval = 1.1-2.7). The results of this study suggest that there may be no immediate prophylactic benefit through the use of AFL to prevent wounds. The incidental finding of a potential reduction in hyperkeratosis and tinea pedis is a compelling one and may deserve further investigation.
This is from Lauren Crutchfiled and Nikki Frescos at Latrobe Uni:
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Prevalence of mycoses in chronic lower limb wounds of people with onychomychosis and/or tinea pedis.
Introduction: Chronic wounds, onychomycosis and tinea pedis can all expose the patient to secondary bacterial infection, which can lead to loss of limb or even loss of life. Anecdotal assessments have found patients with chronic wounds often presented with clinical signs and symptoms of onychomycosis and/or tinea pedis as well. This is a pilot study designed to describe the prevalance of fungi in chronic lower limb wounds in people with onychomychosis and/or tinea pedis.
Method: Twenty-eight consecutive patients with a chronic lower limb wound and a clinical diagnosis of onychomychosis and/or tinea pedis were recruited from two wound management clinics over a five-week period. Wound swabs, toenail clippings and/or skin scrapings were collected from each participant and subjected to mycological examination. Wound swabs were analysed for fungal presence by culture, while both microscopy and culture were used for toenail and skin samples.
Results: Four participants had wound cultures that were positive for fungi which all grew the opportunistic Candida species. All four participants also had onychomychosis confirmed in their toenails by either a microscopy or culture analysis. One participant grew the same fungal species (T.mentagrophytes var. interdigitale) in the wound and toenail culture. Statistical analysis did not generate any significant findings (p>0.05) for fungal presence in wounds compared to wound aetiology, wound duration or positive toenail and skin samples, however fungi-positive wounds compared to wound location were found to be statistically significant (p=0.046).
Discussion: the study aimed to explore the potential relationship between delayed healing in chronic lower limb wounds in the presence of onychomycosis and/or tinea pedis. This preliminary research showed that fungi were present in a small number of chronic lower limb wounds on participants with co-existing onychomychosis. However, the generation of statistical significant results was limited, which suggests a larger clinical trial is therefore required.
Tinea pedis was associated with a lower risk of foot ulcer. No prior information is available on this association.
Tinea pedis is thought to be due in part to sweating, warmth, and use of occlusive footwear, and therefore its presence may be a clinical marker for intact autonomic function, which has been associated with a lower risk of diabetic foot ulcer
__________________ Stephen Tucker Eastern Health
Podiatry Manager
AIMS: The aim was to assess the incidence of isolation of individual fungal species and interpret the meaning of fungal isolates from foot ulcers of 509 diabetic outpatients using mycologic and histopathologic methods. Another aim was to explore risk factors for the development of fungal infections in foot ulcer.
METHODS: Fungus isolation was made on selective media and their identification by standard mycologic methods. Histopathologic diagnosis of fungal ulcer infections was made on PAS-stained histopathologic preparations and imprint preparations (PAS and Papanicolaou staining) of foot wound biopsy specimens.
RESULTS: Fungal and mixed foot ulcer infections were found in 14.9% of diabetic patients. In 33.8% of patients, these infections were confirmed by a finding of fungal elements in histopathologic preparations of ulcer biopsy specimens, as follows: in 16.9% of patients, by finding fungal elements in imprint preparations of ulcer biopsy specimens and by isolation fungus from the swab of the same ulcer; in 2.3% by fungus isolation from ulcer biopsy specimens; in 36.9% by fungus isolation from ulcer swabs in pure culture and/or in a large number of colonies and/or from several ulcers on the foot of the same patient. More than 89% of patients had a single foot ulcer with fungal or mixed infection, big toe and the plantar-metatarsal region in one foot or both feet being the most common sites of ulcer. Fifteen species from the genera Candida, Cryptococcus, Trichosporon and Rhodotorula were the causative agents of fungal and mixed foot ulcer infections. C. parapsilosis (in 61.5% of patients), and C. albicans and C. tropicalis (in 10.8% of patients each) were the most common causes of these infections. The presence of yeasts and/or dermatophytes in the toe web of the same or other foot, or of both feet, did not influence the incidence of fungal and mixed foot ulcer infections. Patient sex and age, type and length of diabetes, or clinical picture of diabetic foot did not affect it either. In IDDM patients, the risk factor for the development of fungal and mixed foot ulcer infections was ulcer infection lasting for more than 13 weeks, whereas in NIDDM patients the length of ulcer infection did not contribute to the incidence of fungal and mixed foot ulcer infection.
DISCUSSION: Our results and other reports suggest that Candida species are the most common fungal isolates (between 93.2% and 100% of all fungal isolates) from diabetic foot ulcer, with C. parapsilosis being the most common causative agent of fungal and mixed infection. From diabetic foot ulcer, bacterial isolation was 5 times as common as that of yeasts (327 vs. 65 patients). Nevertheless, this investigation showed fungal isolates, originating not only from a primarily sterile ulcer sample (biopsy specimen) but also from foot ulcer swabs to be the causative agents (not ulcer colonizers or contaminants) of the foot ulcer infection. The pathogen c effect of yeasts in foot ulcer is indicated by the severity of clinical finding, chronic course of infection, and infection progression despite antibiotic therapy. Equally indicative are microbiologic diagnostic parameters (isolation in pure culture, and/or isolation in a large number of colonies, and/or isolation from several ulcers in the foot of the same patient).
CONCLUSIONS: In diabetic patients at highest risk of developing fungal and mixed foot ulcer infections (IDDM patients with ulcer infection persisting for more than 13 weeks, and NIDDM patients with the clinical picture of deep ulcer and abscess in the plantar region, irrespective of the duration of ulcer infection), routine bacteriologic diagnosis should be supplemented with targeted mycologic and histopathologic methods.
Ciclopirox is said to have some antiinflammatory properties which can help during the inflammation stage of wound healing,so maybe there is a link there.Besides,onychomycosis on a diabetic patient has to be addressed aggressively with debridement plus medicines.T.pedis in this patient population is even worse,as an interdigital maceration can lead to a plantar abcess/infection.
Prevalence of Toe Nail Onychomycosis in Diabetic Patients. Acta Derm Venereol. 2006;86(5):425-428
Saunte DM, Holgersen JB, Haedersdal M, Strauss G, Bitsch M, Svendsen OL, Arendrup MC, Svejgaard EL.
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Onychomycosis among diabetic patients has been reported in some studies to be of high prevalence. This study aimed to investigate the prevalence of onychomycosis among diabetic patients at a Danish University Hospital. Clinical and mycological examinations were performed on type 1 and 2 diabetic patients from in- and out-patient clinics. A total of 271 patients were enrolled, 72% males, mean age 61.3 years, 26% of the patients had diabetes type 1. The prevalence of toe nail onychomycosis (positive culture and/or microscopy) was 22% (n = 59) of which 55 cases were caused by dermatophytes (93%) and 4 cases by yeasts (7%). A correlation was found between onychomycosis and age (p =0.02) and severity of nail changes (p <0.001), respectively. However, no significant correlation was found to gender, type of diabetes, lower extremity arterial disease, neuropathy, toe amputation or oedema. Onychomycosis occurred with a high prevalence in diabetic patients, especially among older patients and those with severe nail changes.
Re: Topical nail antifungal and risk for diabetic foot ulceration
Effects of foot care intervention including nail drilling combined with topical antifungal application in diabetic patients with onychomycosis.
Sumikawa M, Egawa T, Honda I, Yamamoto Y, Sumikawa Y, Kubota M. J Dermatol. 2007 Jul;34(7):456-64.
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We performed periodical foot care intervention including nail drilling combined with topical antifungal application for 6 months or more in 24 diabetic patients with onychomycosis who were not receiving oral antifungals, and evaluated its effects. The type of onychomycosis was superficial white onychomycosis (SWO) in eight patients, and distal-lateral subungual onychomycosis (DLSO) in 16. The state of onychomycosis was evaluated according to the Scoring Clinical Index for Onychomycosis (SCIO). Of the eight patients with SWO, none showed aggravation of the onychomycosis state, and two were cured 6 months after the initiation of intervention and two after 1 year (total of four patients, 50%). In the patients with DLSO, the SCIO score was 18.1 +/- 6.5 before intervention but significantly decreased to 14.6 +/- 6.6 6 months after intervention. In 12 patients who we were able to consecutively follow up for 1 year, the SCIO score also significantly decreased compared with the score before intervention. Thus, foot care intervention including nail drilling combined with topical antifungal application had effects on onychomycosis and achieved cure in some patients with SWO. In addition, intervention increased
Re: Topical nail antifungal and risk for diabetic foot ulceration
Fungal foot infections in patients with diabetes mellitus - results of two independent investigations.
Eckhard M, Lengler A, Liersch J, Bretzel RG, Mayser P. Mycoses. 2007 Sep;50(s2):14-19.
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In diabetic patients, mycotic infections may increase the risk of developing diabetic foot syndrome. However, little data are available on the prevalence of fungal foot infections in patients with diabetes. In a first study published using data obtained during a conference attended by patients with long-term diabetes mellitus type 1 (DM1), 78/95 patients (82.1%) showed probable pedal fungal infections, of which 84.6% (66/78) were mycologically confirmed by direct microscopy and/or culture. The dermatophyte Trichophyton rubrum was the most common (69.2% of isolates). Significant correlation was found between infection and the gender (men more frequently affected) and the age of the patients. Marked mycoses on the soles of the feet were often considered to be dry skin by the patients. In a second study, 174 [31 DM1, 112 DM2 and 29 healthy accompanying persons (HAP), family members without DM] participants at a regional patients' symposium on diabetes took part in an examination for fungal infections and neuropathy of the feet. In addition to the items of the first study, we gathered data on the quality of blood glucose control (HbA1c), peripheral neuropathy (neuropathy symptome and deficit score) and measurement of sudomotoric activity by Neuropadtrade mark. Mean duration of disease was 23.6 (DM1) and 11.2 (DM2) years, mean HbA1c 7.56% (DM1) and 6.89% (DM2) and fungal foot infections were confirmed at 35.5% (DM1), 53.1% (DM2) and 37.9% (HAP) respectively. In DM2, the prevalence of positive fungal samples is significantly higher for participants with less controlled blood glucose (higher HbA1c) (P = 0.04). Mycotic foot infection is also correlated with age, gender and duration of diabetes disease. Of special interest is the finding of relatively high numbers of black fungi ('Dematiaceae') (n = 10), Phialophora europea (n = 3) being the most common one. The sudomotoric activity was impaired in a very high number of participants [107/171 (61.5%)], and was found positively correlated with the prevalence of fungal foot infection in DM2 but not in DM1 and HAP. The high prevalence of fungal infections detected in DM1 as well as in DM2 diabetics is remarkable, especially considering this highly motivated collective. Therefore, it appears that the feet of diabetics require more diagnostic, therapeutic and preventive care in terms of mycotic infections and sudomotoric dysfunction than previously thought.
Re: Topical nail antifungal and risk for diabetic foot ulceration
Nail susceptibility to fungal infection in patients with type 1 and 2 diabetes under long term poor glycaemia control [Article in Polish]
Macura AB, Gasińska T, Pawlik B, Obłoza A. Przegl Lek. 2007;64(6):406-9.
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Onychomycosis is a common disorder in adults. Its prevalence increases also in diabetics. The objective of the study was: 1) evaluation of finger and toe nail susceptibility to Candida albicans and Trichophyton mentagrophytes infection in patients with type 1 and type 2 diabetes with long term glycaemia under poor control as compared with healthy persons, and 2) checking whether or not various aetiology of type 1 and type 2 diabetes may influence the intensity of fungal nail infection. The materials comprised finger and toe nails sampled from 26 patients with type 1 diabetes (20 females and 6 males at average age 51 +/- 10 years), 25 patients with type 2 diabetes (17 females and 8 males at average age 58 +/- 4 years). Twenty two healthy volunteers (18 females and 4 males at average age 47 +/- 14 years) served as controls. All of the diabetics (except one with type 1 diabetes and four with type 2 diabetes) had increased fasting glycaemia; moreover, all of them had poor controlled long term glycaemia because the concentration of glycated haemoglobin HbAlc exceeded 7.5%. The patients with type 1 diabetes were treated with insulin while those with type 2 diabetes with diet only (one person), with gliclazide (sixteen persons), with glimepirid (five persons), and with metformin (four persons). Enhanced fingernail susceptibility to Candida albicans infection was detected in 38.5% of the patients with type 1 diabetes, in 28% of those with type 2 diabetes, and in 22.7% of the controls. Intensive toenail infection was found in 34.6%, 20%, and 22.7% respectively. Enhanced fingernail susceptibility to Trichophyton mentagrophytes infection was found in 30.8% of the patients with type 1 diabetes, in 48% of those with type 2 diabetes, and in 4.54% of the controls while intensive toenail infection in 15.4%, 20%, and 18,2% respectively. Statistical analysis gave evidence of statistically significant higher susceptibility to infection of finger and toe nails with T. mentagrophytes but not with C. albicans in both type 1 and type 2 diabetics, as compared with the controls. In the diabetics, no significant correlation was found between the susceptibility to C. albicans and T. mentagrophytes infection and the age of the patients, metabolic diabetes control (evaluated on the basis of serum glucose level and blood HbAlc concentration), as well as the duration of diabetes.
Re: Topical nail antifungal and risk for diabetic foot ulceration
Onychomycosis incidence in type 2 diabetes mellitus patients.
Manzano-Gayosso P, Hernández-Hernández F, Méndez-Tovar LJ, Palacios-Morales Y, Córdova-Martínez E, Bazán-Mora E, López-Martinez R. Mycopathologia. 2008 Jul;166(1):41-5.
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The onychomycosis incidence was determined in 250 type 2 diabetes mellitus (T2DM) patients who were registered at the Internal Medicine Service from a Mexico city General Hospital throughout a year (January-December 2006). Out of the total of studied T2DM patients, 93 (37.2%) showed ungual dystrophy and from these, in 75.3% a fungal etiology was corroborated. Out of 70 patients, 34 were men and 36 women, with an average of 63.5 years. Correlation between T2DM evolution time and onychomycosis was significant (P < 0.01). Distal-lateral subungual and total dystrophic onychomycosis were the most frequent clinical types (55.1% and 33.7%, respectively). Fifty-eight fungal isolates were obtained; 48.6% corresponded to dermatophytes, Trichophyton rubrum being the first species (37.1%). All these strains corresponded to two morphological varieties: "yellow" and typical downy. From the yeast-like isolates, 12 corresponded to Candida spp., firstly C. albicans and C. parapsilosis; three to Cryptococcus spp. (C. albidus, C. uniguttulatus and C. laurentii); two Trichosporon asahii; and only one to Pichia ohmeri. Six non-dermatophytic molds were isolated: two Chrysosporium keratinophylus, two Scopulariopsis brevicaulis, one Aspergillus fumigatus, and one Acremonium sp. The fungal mixture corresponded to T. mentagrophytes with C. guilliermondii; T. mentagrophytes with C. glabrata; T. rubrum with C. glabrata; T. rubrum with P. ohmeri.
Background: We sought to determine the incidence of tinea pedis in patients with otherwise asymptomatic pedal interdigital macerations. Both diabetic and nondiabetic populations were compared. Age and body mass index were also examined for their significance.
Methods: Fungal cultures of skin scrapings from 80 patients (77 male and 3 female; mean age, 65 years) with interdigital macerations were performed; 40 patients had previously been diagnosed with type 2 diabetes and 40 did not have diabetes.
Results: Cultures revealed a 40% prevalence of tinea pedis in the total study population. The prevalence in the nondiabetic group was 37.5% and 42.5% for the diabetic group. This was not a statistically significant difference. Among patients with interdigital macerations that yielded positive fungal cultures, those in the nondiabetic group were 6.3 years older than those in the diabetic group. It was also observed that the nondiabetic patients with interdigital macerations yielding positive fungal cultures were 9.1 years older than patients with negative fungal cultures in the nondiabetic group.
Conclusion: The results of this study provide the practitioner with a guide for treating pedal interdigital macerations. Because the likelihood of a tinea pedis infection is 40%, it seems prudent to treat these macerations with an antifungal agent. In regard to age, the results suggest that as nondiabetic patients age, the likelihood of an otherwise asymptomatic interdigital maceration yielding a positive fungal culture increases, and that diabetic patients may be susceptible to interdigital fungal infections at a younger age than those without diabetes
duh? That wasn't an incidence study (it was a prevalence study) and it wasn't a prospective study (it was a cross-sectional study) !
__________________
Craig Payne
Department of Podiatry
La Trobe University
Melbourne, Australia http://www.latrobe.edu.au/podiatry
__________________________________________________ ___________________________________ God put me on this earth to accomplish a certain number of things - right now I am so far behind, I will never die.
The views expressed above are those of the author and not that of La Trobe University This is where I am, where are you?
The Following User Says Thank You to Craig Payne For This Useful Post:
Background: An observational study was conducted to assess the prevalence of onychomycosis in clinically suspected diabetic neuropathic patients and to assess the reliability of the diagnosis.
Methods: One hundred successive type 1 and 2 diabetic patients with diabetic neuropathy were followed. Diabetic neuropathy was defined by a vibration perception threshold greater than 25 V and onychomycosis by clinical diagnosis. Samples of the most affected nail were taken. Potassium hydroxide testing and culture were performed. Photographs of the nails were used by two dermatologists for diagnosis.
Results: The mean ± SE age was 62.3 ± 11.4 years for the 20 onychomycotic patients and 60.3 ± 10.4 years for the entire cohort; 14 onychomycotic patients (70%) were male versus 56 in the full cohort (56%) (P < .05). The prevalence of onychomycosis was 20% (culture and potassium hydroxide test positive) and 24% (culture positive). Twenty or 30 patients were positive by the potassium hydroxide test, depending on the investigator. The most frequent pathogen found was Trichophyton rubrum (11 of 20 patients; 55%). The positive predictive values of the dermatologist’s diagnoses were 57.8% and 35.6%, and the negative predictive values were 85.0% and 90.5%. The two expert’s results were significantly different (P < .05).
Conclusions: The diagnosis of onychomycosis is difficult to make. The diagnostic methods commonly used are not satisfactory. If onychomycosis is dangerous for the diabetic foot, a better diagnostic method is needed
OBJECTIVE: To evaluate the ability of two new diagnostic methods to detect and accurately identify yeast associated with chronic wound infections.
METHOD: Fungal tag-encoded FLX amplicon pyrosequencing (fTEFAP), a universal fungal identification method, bacterial tag-encoded FLX amplicon pyrosequencing (bTEFAP), a universal bacterial identification method, and a new quantitative polymerase chain reaction (qPCR) wound pathogen panel were used to evaluate three chronic wounds suspected to contain yeast.
RESULTS: Forty wound samples were analysed in addition to the three samples suspected of containing yeast. The qPCR panel, which targets Candida albicans, detected this yeast in two of the three wound samples. In contrast, fTEFAP detected yeast in each of the three samples: two showed Candida albicans and the third Candida parapsilosis. fTEFAP also identified a lower level of Candida tropicalis in one of the wounds that was positive for Candida albicans. The qPCR wound panel results were returned within two hours, while the fTEFAP results were returned within 24 hours.
CONCLUSION: Two new molecular methods have been developed to aid wound pathogen diagnostics. The quantitative PCR wound panel is rapid but is limited to major wound-associated bacteria and yeasts. The universal fTEFAP and bTEFAP methods take 24 hours to return results but are able to detect the relative contribution of any bacteria of yeast in a chronic wound diagnostic sample. DECLARATION OF INTEREST: Southwest Regional Wound Care Center is a clinical wound-care provider seeking to improve the ability of wound care practitioners to help patients. The Research and Testing Laboratory develops molecular methods including fTEFAP, bTEFAP and the quantitative PCR wound panel
Diabetes mellitus may be associated with serious sequelae, such as renal disease, retinopathy, and diabetic foot. A recent large prospective study has shown that onychomycosis is among the most significant predictors of foot ulcer. As the severity of onychomycosis may be associated with the length of time the individual has had the infection, early intervention is advisable owing to the progressive nature of the fungal infection. If left untreated, toenails can become thick, causing pressure and irritation, and thus act as a trigger for more severe complications. In the treatment of onychomycosis, compliance and drug interactions are important considerations, as diabetic patients frequently take concomitant medications. Terbinafine and itraconazole have been investigated for the treatment of onychomycosis in diabetic patients and have been shown to have efficacy and safety profiles comparable to those in the nondiabetic population. Data from clinical trials and postmarketing surveillance suggest that drug interactions resulting in hypoglycemia may not be an important issue when itraconazole and terbinafine are used to treat diabetic patients receiving concomitant hypoglycemic medications. Patient advice and education in improved foot care are an integral part of onychomycosis management, and help achieve long-term cure and reduce the complications of diabetic foot.
Aims To review the current evidence for the presence of fungal foot infection (tinea pedis and toenail onychomycosis) as a risk factor for the development of cellulitis within the lower limb, particularly for those individuals with diabetes.
Methods A structured review of medline, embase and cinahl databases was undertaken to identify publications investigating fungal foot infection as a risk factor for the development of cellulitis.
Results Sixteen studies were identified. Eight studies adopted a case-control methodology, with the remainder being cross-sectional surveys. The majority of studies established the presence of tinea infection by clinical rather than established microbiological methods. Although the majority of papers suggested a link, only two case-control studies employed microbiological diagnosis to demonstrate that fungal foot infection was a risk for the development of lower limb cellulitis, particularly when infection was located between the toes. There were insufficient data to suggest that fungal foot infection posed an increased risk to patients with diabetes.
Conclusion There is some evidence to suggest that fungal infection of the foot is a factor in the development of lower limb cellulitis, but further robust research is needed to confirm these findings and quantify the risk that fungi pose, particularly to the diabetic foot. Meanwhile, improved surveillance and treatment of tinea infections on the foot by healthcare professionals should be encouraged to reduce potential complications.
Topical nail antifungal and risk for diabetic foot ulceration
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