Bioburden Predictors of Diabetic Ulcer Complications

描述（由申请人提供）：很难确定由感染相关并发症引起的糖尿病足溃疡（DFU）。本应用程序的目的是制定策略，以准确识别可能继续发展为感染相关并发症的dfu。目的是1)确定a)高微生物负荷，b)微生物多样性，以及c)基于使用Levine's技术获得的痰签培养的金黄色葡萄球菌和厌氧菌的预后效果，以预测无临床感染迹象的糖尿病足溃疡的感染相关并发症；2)确定组合微生物维度对任何单一维度预测能力的提高程度。前瞻性研究设计将用于观察dfu在伤口关闭前的感染相关并发症。150例无临床感染迹象的dfu患者将被评估伤口生物负荷，并每两周随访感染相关并发症，直到1)伤口愈合，2)dfu相关截肢，3)失去随访或4)6个月的数据收集结束。伤口生物负荷有三个方面：微生物负荷、微生物多样性和有毒生物的存在。每个维度将通过使用莱文的技术获得的定量培养拭子标本来测量。Levine的技术从深层组织层取样液体，与伤口组织培养相比，已被证明是伤口生物负荷的有效测量。在每次随访期间将重复收集伤口生物负荷测量。此外，伤口恶化、骨髓炎或截肢的结果将在随访期间进行评估。ROC分析以ROC曲线下面积（AUC）来评估预后效果。将考虑两种结果：(a)伤口愈合前伤口恶化和/或骨髓炎的发展，以及(b)伤口愈合前截肢。将使用多变量逻辑回归开发一个复合预测器。这项研究的结果将提高dfu发生并发症的风险与非风险之间的区别。通过这种方式，资源可以更经济有效地用于患者，对他们进行更有力的干预可以防止不良后果。

DESCRIPTION (provided by applicant): It is difficult to identify diabetic foot ulcers (DFU) destined for infection-related complications. The objective of this application is to develop strategies to accurately identify DFUs that are likely to proceed to develop infection-related complications. The aims are to 1) determine the prognostic efficacy of a) high microbial load, b) microbial diversity, and c) Staphylococcus aureus and anaerobes based on swab cultures obtained using Levine's technique in predicting infection-related complications among diabetic foot ulcers without signs of clinical infection; and 2) Determine the extent to which combining microbiological dimensions will improve the predictive ability above any single dimension. A prospective research design will be used to observe infection-related complications among DFUs before wound closure. A sample of 150 subjects with DFUs but without signs of clinical infection will be assessed for wound bioburden and followed for infection-related complications every two weeks until 1) wound closure, 2) DFU-related amputation, 3) loss to follow-up or 4) the end of six months of data collection. Wound bioburden has three dimensions: microbial load, microbial diversity, and presence of virulent organisms. Each dimension will be measured by quantitatively culturing swab specimens obtained using Levine's technique. Levine's technique samples fluid from deep tissue layers and has been shown to be a valid measure of wound bioburden when compared to cultures of wound tissue. Repeat measures of wound bioburden will be collected during each follow-up. In addition, the outcomes of wound deterioration, osteomyelitis, or amputation will be assessed during follow-up. ROC analysis will be used to evaluate the prognostic efficacy in terms of area under the ROC curve (AUC). Two outcomes will be considered: (a) the development of wound deterioration and/or osteomyelitis before wound closure, and (b) amputation before wound closure. A composite predictor will be developed using multivariable logistic regression. The findings from this research will improve the discrimination of DFUs at-risk from those not-at-risk for developing complications. In this way, resources can be more cost efficiently directed toward patients for whom more vigorous interventions can prevent undesirable outcomes.