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Clinical predictors of treatment failure for diabetic foot infections: data from a prospective trial.
Lipsky BA, Sheehan P, Armstrong DG, Tice AD, Polis AB, Abramson MA. Int Wound J. 2007 Mar;4(1):30-8.
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To aid clinicians in selecting the appropriate approach for treating patients with diabetic foot infections, we investigated whether any baseline clinical findings predicted an unfavourable clinical outcome. Using data from a large, prospective treatment trial of diabetic foot infections (SIDESTEP), we assessed the association between clinical treatment failure and baseline history, physical and laboratory findings, by univariate and multivariate logistic regression analyses. Among 402 patients clinically evaluable 10 days after completing antibiotic therapy, baseline factors significantly (P < 0.05) associated by univariate analysis with treatment failure were 'severe' (versus 'moderate') University of Texas (UT) wound grade; elevated white blood cell count, C-reactive protein or erythrocyte sedimentation rate; high wound severity score; inpatient treatment; low serum albumin; male sex; and skin temperature of affected foot >10 degrees C above that of unaffected foot. By multivariate logistic regression only severe UT wound grade (odds ratio 2.1) and elevated white blood cell count [odds ratio 1.7 for a 1 standard deviation (2971 cells/mm(3)) increase] remained statistically significant. Clinical failure rates were 46% for patients with both risk factors compared with 10% for patients with no risk factors and 16-17% for patients with one risk factor. Increased white blood cell count and severe UT wound grade at baseline, but not other features, were significant independent and additive risk factors for clinical failure in patients treated for a diabetic foot infection.
Re: Predictors of treatment failure for diabetic foot infections
Risk factors associated with adverse outcomes in a population-based prospective cohort study of people with their first diabetic foot ulcer.
Winkley K, Stahl D, Chalder T, Edmonds ME, Ismail K. J Diabetes Complications. 2007 Nov-Dec;21(6):341-9.
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AIMS/HYPOTHESIS: The aim of this study was to determine which clinic-based measures of diabetes and foot status at baseline were associated with adverse outcomes 18 months later in people with diabetes presenting with their first foot ulcer.
SUBJECTS AND METHODS: This was a prospective population-based cohort study of adults with type 1 and type 2 diabetes mellitus presenting with their first foot ulcer (excluding those with severe ischaemia, ankle brachial pressure index <0.5). The main explanatory variables were age, sex, smoking status, ulcer site (dorsal or plantar), size and severity of ulcer, severity of neuropathy, ischaemia, glycosylated haemoglobin, presence of micro- and macrovascular complications, and depression. The main outcomes recorded were death, amputation and recurrence of ulceration, and the time taken for each outcome to occur.
RESULTS: Two hundred fifty-three people were recruited. There were 40 deaths (15.8%), 36 amputations (15.5%), and 99 recurrences (43.2%) at 18 months. Our main findings were that being older [hazard ratio (HR) 1.07, 95% CI 1.04-1.11], having lower glycosylated haemoglobin (HR 0.73, 95% CI 0.56-0.96), moderate ischaemia (HR 2.74, 95% CI 1.46-5.14), and depression (HR 2.51, 95% CI 1.33-4.73) were associated with mortality. Ulcer severity was the only explanatory factor significantly associated with amputation (HR 3.18, 95% CI 1.53-6.59). Microvascular complications were the only explanatory factor associated with recurrent ulceration (HR 3.34, 95% CI 1.17-9.56).
CONCLUSIONS/INTERPRETATION: Commonly used primary and secondary care clinic-based measures could provide the basis for a risk assessment tool for adverse outcomes following first presentation of diabetic foot ulcers.
Factors associated with treatment failure in patients with diabetic foot infections: An analysis of data from randomized controlled trials.
Vardakas KZ, Horianopoulou M, Falagas ME. Diabetes Res Clin Pract. 2008 Feb 19 [Epub ahead of print]
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BACKGROUND: Although several antibiotics have been studied for the treatment of foot infections, their effectiveness has been considered to be similar. The scope of this analysis was the identification of factors that are associated with treatment failure based on evidence from randomized controlled trials (RCTs).
METHODS: Two reviewers independently extracted data from published RCTs comparing different antibiotics for diabetic foot infections (DFIs).
RESULTS: The combined observed treatment failure was 22.7% in the 18 RCTs included in the analysis. When different regimens of various antibiotics (penicillins, carbapenems, cephalosporins, and fluoroquinolones) were directly compared in the individual RCTs, they were associated with similar frequency of treatment failure. However, when all patients were combined, carbapenems were associated with fewer treatment failures. Also, treatment failure in patients with DFIs from whom methicillin-resistant S. aureus (MRSA) alone or as part of a polymicrobial infection was isolated was more common than in patients from whom other bacteria were isolated [24/68 (35.3%) versus 350/1522 (23%), p=0.02]. Among patients with DFIs due to MRSA the use of linezolid was not associated with better effectiveness in comparison to other antibiotics [treatment failure: 6/19 (31.6%) versus 18/49 (36.7%), p=0.69]. Of interest, treatment failure was similar in patients with and without osteomyelitis [44/169 (26.5%) versus 330/1424 (23.2%), p=0.34].
CONCLUSIONS: The isolation of MRSA seems to be a significant factor associated with treatment failure in patients with DFIs. Further research efforts are needed for the identification of additional risk factors for treatment failure and optimization of the management of patients with DFIs.
Re: Predictors of treatment failure for diabetic foot infections
Clinical Profile and Management Outcome of Diabetic Foot Ulcers in a Tertiary Care Hospital.
Mehmood K, Akhtar T, Talib A, Talib A, Abbasi B, Salekeen SU, Naqvi IH. J Coll Physicians Surg Pak. 2008 Jul;18(7):408-412
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Ojective: To determine major risk factors and management outcome of diabetic foot ulcers in order to prevent amputation.Study Design: Cross-sectional descriptive study.
Place and Duration of Study: Study was conducted at the Department of Medicine, Civil Hospital Karachi, from January 2005 to December 2006.
Patients and Methods: One-hundred and sixteen consecutive diabetic patients, with foot ulcers of Wagner's grade 1 to 4 were assessed at baseline for demographic information, detailed history, neuropathy, peripheral pulses and frequency of diabetic complication. Glycemic control was determined on the basis of HbA1c levels. Appropriate medical and surgical treatments were carried out and patients were followed-up until healing or for 6 months as end point of study. Outcome was recorded as healed, incomplete healing and amputated.
Results: A majority of subjects had type 2 diabetes (95.7%) with male predominance (66%). The mean age was 54.29 +/- 7.71 years. Most of the patients were overweight, hyperglycemic and had diabetes > 10 years duration. Neuropathic ulcers were found in 91 (78.4%) patients, while rest of the 25 (22.6 %) had neuroischemic ulcers. Wound cultures revealed polymicrobial organisms. Foot ulcers of 89 (77.7%) patients healed without amputation and 17 (14.7%) patients had minor or major amputations. Long-duration of diabetes, poor glycemic control and type of foot ulcers had effect on prognosis (p<0.05).
Conclusion: Effective glycemic control, optimal wound care, aggressive medical management and timely surgical intervention may decrease disabling morbidity with better outcome of diabetic foot ulcer.
Re: Predictors of treatment failure for diabetic foot infections
The value of a wound score for diabetic foot infections in predicting treatment outcome: A prospective analysis from the SIDESTEP trial.
Lipsky BA, Polis AB, Lantz KC, Norquist JM, Abramson MA. Wound Repair Regen. 2009 Aug 11. [Epub ahead of print]
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ABSTRACT Scoring the severity of a diabetic foot wound infection may help assess the severity, determine the type and urgency of antibiotic and surgical treatment needed, and predict clinical outcomes. We developed a 10-item diabetic foot infection wound score (results could range from 3 to 49 [least to most severe]) incorporating semi-quantitative grading of both wound measurements and various infection parameters. Using data from a prospective diabetic foot infection antibiotic trial (SIDESTEP), we evaluated the score's accuracy in predicting outcome, analyzed its components and tested it for consistency, construct, and validity. Wound scores for 371 patients significantly correlated with the clinical response; it was favorable at the follow-up assessment in 94.8% with a baseline score </=12 compared with 77.0% with a score >19. Scores demonstrated good internal consistency (Cronbach's alpha >0.70 to <0.95). Patients with more severe wounds had higher scores, supporting construct validity. Excluding scores for wound discharge (purulent and nonpurulent), leaving an eight-item score, provided better measurement statistics. This easily performed wound score appears to be a reliable, valid, and useful tool for predicting clinical outcomes. Further validation studies in different patient populations should refine the items included.