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A series of systematic reviews to inform a decision analysis for sampling and treating infected diabetic foot ulcers.
Health Technol Assess. 2006 Apr;10(12):1-238
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OBJECTIVES: To review systematically the evidence on the performance of diagnostic tests used to identify infection in diabetic foot ulcers (DFUs) and of interventions to treat infected DFUs. To use estimates derived from the systematic reviews to create a decision analytic model in order to identify the most effective method of diagnosing and treating infection and to identify areas of research that would lead to large reductions in clinical uncertainty.
DATA SOURCES: Electronic databases covering period from inception of the database to November 2002.
REVIEW METHODS: Selected studies were assessed against validated criteria and described in a narrative review. The structure of a decision analytic model was derived for two groups of patients in whom diagnostic tests were likely to be used.
RESULTS: Three studies that investigated the performance of diagnostic tests for infection on populations including people with DFUs found that there was no evidence that single items on a clinical examination checklist were reliable in identifying infection in DFUs, that wound swabs perform poorly against wound biopsies, and that semi-quantitative analysis of wound swabs may be a useful alternative to quantitative analysis. However, few people with DFUs were included, so it was not possible to tell whether diagnostic performance differs for DFUs relative to wounds of other aetiologies. Twenty-three studies investigated the effectiveness (n = 23) or cost-effectiveness (n = 2) of antimicrobial agents for DFUs. Eight studied intravenous antibiotics, five oral antibiotics, four different topical agents such as dressings, four subcutaneous granulocyte colony stimulating factor (G-CSF), one evaluated oral and topical Ayurvedic preparations and one compared topical sugar versus antibiotics versus standard care. The majority of trials were underpowered and were too dissimilar to be pooled. There was no strong evidence for recommending any particular antimicrobial agent for the prevention of amputation, resolution of infection or ulcer healing. Topical pexiganan cream may be as effective as oral antibiotic treatment with ofloxacin for the resolution of local infection. Ampicillin and sulbactam were less costly than imipenem and cilastatin, a growth factor (G-CSF) was less costly than standard care and cadexomer iodine dressings may be less costly than daily dressings. A decision analytic model was derived for two groups of people, those for whom diagnostic testing would inform treatment -- people with ulcers which do not appear infected but whose ulcer is not progressing despite optimal concurrent treatment -- and those in whom a first course of antibiotics (prescribed empirically) have failed. There was insufficient information from the systematic reviews or interviews with experts to populate the model with transition probabilities for the sensitivity and specificity of diagnosis of infection in DFUs. Similarly, there was insufficient information on the probabilities of healing, amputation or death in the intervention studies for the two populations of interest. Therefore, we were unable to run the model to inform the most effective diagnostic and treatment strategy.
CONCLUSIONS: The available evidence is too weak to be able to draw reliable implications for practice. This means that, in terms of diagnosis, infection in DFUs cannot be reliably identified using clinical assessment. This has implications for determining which patients need formal diagnostic testing for infection, on whether empirical treatment with antibiotics (before the results of diagnostic tests are available) leads to better outcomes, and on identifying the optimal methods of diagnostic testing. With respect to treatment, it is not known whether treatment with systemic or local antibiotics leads to better outcomes or whether any particular agent is more effective. Limited evidence suggests that both G-CSF and cadexomer iodine dressings may be less expensive than 'standard' care, that ampicillin/sulbactam may be less costly than imipenem/cilastatin, and that an unlicensed cream (pexiganan) may be as effective as oral ofloxacin. Further research is needed to ascertain the characteristics of infection in people with DFUs that influence healing and amputation outcomes, to determine whether detecting infection prior to treatment offers any benefit over empirical therapy, and to establish the most effective and cost-effective methods for detecting infection, as well as the relative effectiveness and cost-effectiveness of antimicrobial interventions for DFU infection.
OBJECTIVE: To investigate the change of bacterial load applied with iodophors and rivanol of diabetic foot ulcers (DFUs), furthermore to evaluate the effect of both in removing superficial microbes of DFUs.
METHODS: From March 2006 to March 2007, 30 patients were randomly divided into control group (group A, n = 10), iodophor group (group B, n = 10) and rivanol group (group C, n = 10). There were 18 males and 12 females with an average age of 59.8 years (range 46-78 years). The wound size ranged from 3 cm x 2 cm to 15 cm x 10 cm. The disease course was 6 weeks to 6 months (mean 2.1 months). Each wound was debrided and irrigated before process, then drug was compressed on the wound for 5 minutes, and irrigated again. The samples gained for three times, before, immediately and 24 hours after the process. Each sample was diluted before cultivation, the bacteria of wound were counted and compared among 3 groups.
RESULTS: The cultures of specimens showed that the load decreased in every group, each cultured colony of specimen grew well, and there were no significant differences between 3 groups immediately after procedure (P > 0.05). There were significant differences between group B and groups A, C (P < 0.05), but there were no significant difference between group A and group C 24 hours after treatment (P > 0.05).
CONCLUSION: Both iodophors and rivanol could remove the bacteria on the surface of wound. Topical germicide could reduced bacterial load in the wound of diabetic foot, the role of sterilizing and bacteriostasis of iodophors were better than that of rivanol.
Foot infections in diabetes (DFIs) in the out-patient setting: an Italian multicentre observational survey
S. Esposito, S. Leone, S. Noviello, M. Fiore, F. Ianniello, F. M. Felaco, F. Romagnoli and E. Sarli Diabet. Med. 25, 979–984 (2008)
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Aims To conduct a multicentre observational study to describe management of foot infections in diabetes in the out-patient setting in Italy.
Patients and methods Ten centres equally distributed nationwide were asked to collect, by means of a spreadsheet (Access/Excel Microsoft program), data concerning 30 consecutive diabetic patients with foot infections deemed suitable for antibiotic treatment in the out-patient setting. Centres with ≥ 5 years' experience of out-patient management were selected. Data from 271 consecutive patients treated as out-patients were collected and analysed by the central coordinator. Statistical analysis was performed using the SPSS statistical software package.
Results Lesions were mainly located at the toes and midfoot (33.6 and 30.2%, respectively); 63 (23.2%) patients had multiple ulcers. Seventy (25.8%) patients also had concomitant osteomyelitis. Three hundred and four pathogens, including Gram-positive and Gram-negative aerobes and anaerobes, were isolated in 219/271 patients (80.8%) by culturing debrided tissue (71.2%) or purulent material (28.8%). Infections were polymicrobial in 33.8% of patients. The most common pathogens were Staphylococcus aureus (27.3%) and Pseudomonas spp. (20.4%); enterobacteriaceae, enterococci, streptococci and anaerobes accounted for 11.5, 7.6, 6.9 and 1.9%, respectively. Antibiotics were frequently administered by parenteral route and frequently in combination. Piperacillin/tazobactam was the parenteral antibiotic most frequently utilized (21.1%). Cure/improvement was observed in 93.4% of patients.
Conclusions Foot ulcers in diabetes are common and serious; the aetiology is often polymicrobial, often including S. aureus and Pseudomonas spp. Treatment in the out-patient setting is safe and effective, and penicillins together with β-lactamase inhibitors and fluoroquinolones are the most frequent choice.
Foot infections in diabetes (DFIs) in the out-patient setting: an Italian multicentre observational survey.
Esposito S, Leone S, Noviello S, Fiore M, Ianniello F, Felaco FM, Romagnoli F, Sarli E. Diabet Med. 2008 Aug;25(8):979-84.
Quote:
AIMS: To conduct a multicentre observational study to describe management of foot infections in diabetes in the out-patient setting in Italy.
PATIENTS AND METHODS: Ten centres equally distributed nationwide were asked to collect, by means of a spreadsheet (Access/Excel Microsoft program), data concerning 30 consecutive diabetic patients with foot infections deemed suitable for antibiotic treatment in the out-patient setting. Centres with > or = 5 years' experience of out-patient management were selected. Data from 271 consecutive patients treated as out-patients were collected and analysed by the central coordinator. Statistical analysis was performed using the SPSS statistical software package.
RESULTS: Lesions were mainly located at the toes and midfoot (33.6 and 30.2%, respectively); 63 (23.2%) patients had multiple ulcers. Seventy (25.8%) patients also had concomitant osteomyelitis. Three hundred and four pathogens, including Gram-positive and Gram-negative aerobes and anaerobes, were isolated in 219/271 patients (80.8%) by culturing debrided tissue (71.2%) or purulent material (28.8%). Infections were polymicrobial in 33.8% of patients. The most common pathogens were Staphylococcus aureus (27.3%) and Pseudomonas spp. (20.4%); enterobacteriaceae, enterococci, streptococci and anaerobes accounted for 11.5, 7.6, 6.9 and 1.9%, respectively. Antibiotics were frequently administered by parenteral route and frequently in combination. Piperacillin/tazobactam was the parenteral antibiotic most frequently utilized (21.1%). Cure/improvement was observed in 93.4% of patients.
CONCLUSIONS: Foot ulcers in diabetes are common and serious; the aetiology is often polymicrobial, often including S. aureus and Pseudomonas spp. Treatment in the out-patient setting is safe and effective, and penicillins together with beta-lactamase inhibitors and fluoroquinolones are the most frequent choice.
Introduction: The prevalence of diabetes mellitus is high in Singapore. Infections of the lower limb are significant causes of morbidity in this population. Although the aerobic bacteriology of these infections is well-documented, there is less data available on the anaerobic pathogens involved. This study sets out to describe the anaerobic bacteria associated with diabetic foot infections, and evaluates the susceptibility to 3 antimicrobials with anaerobic activity. Materials and Methods: Anaerobic culture was performed on operative samples taken from diabetic foot infections. Organisms were identified through standard microbiological methods and commercial identification kits. Antimicrobial susceptibility testing to clindamycin, metronidazole and imipenem was performed by agar dilution. Results: One hundred and two strains of strict anaerobic bacteria were isolated from 30 unique specimens. The predominant anaerobic isolates were Peptostreptococcus spp. (46%) and Bacteroides fragilis group (19%). Antibiotic resistance was detected for clindamycin (18%), metronidazole (1%) and imipenem (2%). Conclusion: Multiple anaerobic species can be isolated from diabetic foot infections. A significant proportion of isolates are resistant to clindamycin, while resistance to imipenem and metronidazole remains low.
Aims. One proposed method to diagnose diabetic foot ulcers (DFUs) for infection is clinical examination. Twelve different signs of infection have been reported. The purpose of this study was to examine diagnostic validity of each individual clinical sign, a combination of signs recommended by the Infectious Disease Society of America (IDSA), and a composite predictor based on all signs of localized wound infection in identifying DFU infection, among a sample of DFUs.
Methods. A cross-sectional research design was used. Sixty-four individuals with DFUs were recruited from a Department of Veterans Affairs Medical Center and an academic-affiliated hospital. Each DFU was independently assessed by 2 research team members using the clinical signs and symptoms checklist. Tissue specimens were then obtained via wound biopsy and quantitatively processed. Ulcers with more than 10(6) organisms per gram of tissue were defined as having high microbial load. Individual signs and the IDSA combination were assessed for validity by calculating sensitivity, specificity, and concordance probability. The composite predictor was analyzed using c-index and receiver operating curves.
Results. Twenty-five (39%) of the DFUs had high microbial loads. No individual sign was a significant predictor of high microbial load. The IDSA combination was not a significant predictor either. The c-index of the composite predictor was .645 with a 95% confidence interval of .559-.732.
Conclusions. Individual signs of infection do not perform well nor does the IDSA combination of signs. However, a composite predictor based on all signs provides a moderate level of discrimination, suggesting clinical use. Larger sample sizes and alternate reference standards are recommended.
Our aim was to evaluate the role of SPECT/CT for the diagnosis of diabetic foot infection by labeled leukocytes.
METHODS: Seventeen patients with 19 clinically suspected sites of infection were included. After leukocyte labeling and administration, planar scans were acquired at 30 min, 4 h, and 24 h for 18 consecutive patients. SPECT/CT was obtained at 6 h. The final diagnosis was established by clinical follow-up (24 mo) in all cases and by bone biopsy for 14 sites.
RESULTS: Leukocyte scanning was positive in 16 of 19 lesions and negative in 3. SPECT/CT changed the interpretation of the planar and SPECT images for 10 of 19 suspected sites (52.6%): it excluded osteomyelitis in 6 cases, revealed bone infection in 1 case, and revealed both bone and soft-tissue infection in 3 cases. The hybrid device did not significantly contribute to the evaluation of patients with negative scan results.
CONCLUSION: SPECT/CT can be useful for a more accurate diagnosis of diabetic foot infection by labeled leukocyte imaging.
Infected diabetic foot ulcers decision making
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