Bioburden Predictors of Diabetic Ulcer Complications

糖尿病溃疡并发症的生物负载预测因子

• 批准号: 7480996
• 负责人: SUE E GARDNER
• 金额: $ 61.8万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-08-08 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7480996
• 关键词: Address; Algorithms; Amputation; Anaerobic Bacteria; Antibiotics; Area; Area Under Curve; Biopsy; Bone Tissue; Chronic; Clinical; Clinical Data; Clinical Management; Closure; Communities; Confidence Intervals; Data Collection; Depth; Deterioration; Development; Diabetic Foot; Diabetic Foot Ulcer; Diabetic ulcer; Diagnostic; Dimensions; Discrimination; Foot Ulcer; Goals; Gold; Hand; Infection; Inflammatory Response; Intervention; Invasive; Laboratory Procedures; Liquid substance; Logistic Regressions; Measures; Methicillin Resistance; Numbers; Organism; Osteomyelitis; Outcome; Patients; Persons; Population; Predictive Value; Prevention; Procedures; Purpose; ROC Curve; Range; Receiver Operating Characteristics; Research; Research Design; Resources; Risk; Role; Sampling; Science; Screening procedure; Sensitivity and Specificity; Signs and Symptoms; Specificity; Specimen; Standards of Weights and Measures; Staphylococcus aureus; Surface; Swab; Techniques; Testing; Tissues; Variant; Virulent; Week; Work; Wound Healing; base; cost; follow-up; improved; innovation; microbial; prevent; prognostic; prospective; tool; wound

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.

描述（由申请人提供）：很难识别出针对感染相关并发症的糖尿病足溃疡（DFU）。该应用程序的目的是制定策略，以准确识别可能会发展与感染相关并发症的DFU。目的是1）确定a）高微生物载荷的预后功效，b）微生物多样性以及c）基于使用莱文技术在没有糖尿病脚溃疡的糖尿病并发性症状的诊断技术中获得的基于使用莱文与感染相关的并发性症状的无关感染迹象的粘液培养物的金黄色葡萄球菌和厌氧菌的预后效应； 2）确定合并微生物学维度的程度将在任何单个维度上提高预测能力。前瞻性研究设计将用于观察伤口闭合前DFU中与感染有关的并发症。将评估150名患有DFU的受试者的样本，但没有临床感染迹象的伤口生物负责人，随后每两周一次与感染相关的并发症，直到1）1）伤口闭合，2）DFU相关截肢，3）随访或4）六个月的数据收集六个月。伤口生物负荷具有三个维度：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技术获得的定量培养拭子标本来衡量。与伤口组织培养物相比，Levine的技术样本从深层组织层中样本的液体被证明是伤口生物负荷的有效度量。在每次随访期间，将收集伤口生物负担的重复测量。此外，在随访期间将评估伤口恶化，骨髓炎或截肢的结局。 ROC分析将用于评估ROC曲线（AUC）下面积的预后功效。将考虑两个结果：（a）伤口闭合前的伤口恶化和/或骨髓炎的发生，以及（b）截肢闭合前的截肢。将使用多变量逻辑回归开发复合预测变量。这项研究的发现将改善DFUS处于危险中的DFUS歧视，因为那些不风险的并发症。这样，资源可以更有效地指向更有力的干预措施的患者。