Comparison of the predictive efficacy of the Wagner, SINBAD, and WIfI grading systems for short-term wound non-healing and amputation in patients with diabetic foot ulcers
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摘要:
目的 比较Wagner分级系统和部位、缺血、神经病变、细菌感染、面积、深度（SINBAD）分级系统以及伤口、缺血和足部感染（WIfI）分级系统对糖尿病足溃疡（DFU）患者短期创面未愈合与截肢的预测效能。 方法 该研究为回顾性队列研究。2023年1月—2024年12月,华中科技大学同济医学院附属武汉中心医院糖尿病足专病中心收治400例符合入选标准的DFU患者,均在入院后48 h内完成Wagner分级、SINBAD评分及WIfI分期评估。患者中男232例、女168例,年龄44~83岁。按照首次入院3个月时创面是否愈合,将患者分为愈合组（194例）和未愈合组（206例）；另按照患者截肢情况,将行大截肢、小截肢患者纳入截肢组（255例）,其余患者纳入未截肢组（145例）；统计各组患者的Wagner分级、SINBAD评分、WIfI分期。另比较不同Wagner分级、SINBAD评分、WIfI分期患者的截肢情况、首次入院3个月时创面未愈合情况。采用Spearman相关性分析评估Wagner分级、SINBAD评分、WIfI分期与DFU患者创面愈合时间的相关性。绘制受试者操作特征曲线评估各分级系统对DFU患者首次入院3个月时创面未愈合和截肢的预测效能,并采用DeLong检验比较各分级系统的受试者操作特征曲线下面积（AUROC）差异。 结果 未愈合组、截肢组患者的Wagner分级、SINBAD评分、WIfI分期分别明显高于愈合组、未截肢组（t值分别为8.25、19.78、9.87,14.05、11.73、16.45,P<0.05）。不同Wagner分级、SINBAD评分、WIfI分期患者组内截肢患者数、首次入院3个月时创面未愈合患者数比较,差异均有统计学意义（χ2值分别为150.35、73.97,133.84、221.10,187.63、83.37,P<0.05）。Wagner分级、SINBAD评分及WIfI分期均与DFU患者创面愈合时间呈明显正相关（rs分别为0.52、0.70、0.52,P<0.05）。以DFU患者首次入院3个月时创面未愈合为预后观察结局,SINBAD分级系统的AUROC最高,为0.96（95%CI为0.94~0.98）,最大约登指数为0.80；Wagner分级系统的AUROC为0.66（95%CI为0.61~0.72）,最大约登指数为0.28；WIfI分级系统的AUROC为0.69（95%CI为0.64~0.74）,最大约登指数为0.33。DeLong检验显示,SINBAD分级系统对DFU患者短期创面未愈合的预测效能明显优于Wagner分级系统和WIfI分级系统（Z值分别为12.52、12.97,P值均<0.05）。以DFU患者截肢为预后观察结局,WIfI分级系统的AUROC最高,为0.89（95%CI为0.85~0.93）,最大约登指数为0.75；Wagner分级系统的AUROC为0.87（95%CI为0.83~0.91）,最大约登指数为0.55；SINBAD分级系统的AUROC为0.80（95%CI为0.76~0.84）,最大约登指数为0.43。DeLong检验显示,WIfI分级系统和Wagner分级系统对DFU患者截肢的预测效能均明显优于SINBAD评分（Z值分别为3.76、2.96,P<0.05）。 结论 Wagner分级系统、SINBAD分级系统及WIfI分级系统能有效预测DFU患者的短期创面未愈合和截肢风险。其中SINBAD分级系统在预测短期创面未愈合方面表现最优,而WIfI分级系统在预测截肢方面更具优势,Wagner分级系统虽然在短期创面未愈合方面的预测效能较差,但对截肢具有较好的预测效能。临床实践中可根据评估重点,联合应用不同分级系统。 Abstract:Objective To compare the predictive efficacy of the Wagner grading system, site, ischemia, neuropathy, bacterial infection, area, depth (SINBAD) grading system, and wound, ischemia and foot infection (WIfI) grading system for short-term wound non-healing and amputation in patients with diabetic foot ulcers (DFUs). Methods This study was a retrospective study of case series. From January 2023 to December 2024, 400 patients with DFUs who met the inclusion criteria were admitted to the Diabetic Foot Center of the Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology. All patients were assessed with Wagner grade, SINBAD score, and WIfI stage within 48 hours of admission. There were 232 males and 168 females, aged 44 to 84 years. Based on whether the wound had healed at 3 months after the first hospitalization, patients were divided into healing group (194 cases) and non-healing group (206 cases); based on amputation, patients who underwent major or minor amputation were included in amputation group (255 cases), while the remaining patients were included in non-amputation group (145 cases); the Wagner grades, SINBAD scores, and WIfI stages of patients in each group were recorded. The amputation and non-healing wound at 3 months after the first admission in patients with different Wagner grades, SINBAD scores, or WIfI stages were compared. Spearman correlation analysis was used to assess the correlation between the Wagner grades, SINBAD scores, WIfI stages and the wound healing time in patients with DFUs. The receiver operating characteristic curves were plotted to evaluate the predictive efficacy of each grading system for non-healing wound at 3 months after the first admission and amputation in patients with DFUs, and the DeLong test was used to compare the differences in the area under the receiver operating characteristic curve (AUROC) among the grading systems. Results The patients in non-healing group and amputation group had significantly higher Wagner grades, SINBAD scores, and WIfI stages than those in healing group and non-amputation group, respectively (with t values of 8.25, 19.78, and 9.87, 14.05, 11.73, and 16.45, P<0.05). There were statistically significant differences among the numbers of patients who underwent amputation and the numbers of patients with non-healing wounds at 3 months after the first admission in patients with different Wagner grades, SINBAD scores, or WIfI stages (with χ2 values of 150.35 and 73.97, 133.84 and 221.10, 187.63 and 83.37, P<0.05). The Wagner grades, SINBAD scores, and WIfI stages were all significantly positively correlated with the wound healing time in patients with DFUs (with rs values of 0.52, 0.70, and 0.52, respectively, P<0.05). With wounds unhealed at 3 months after the first admission as the prognostic outcome, the SINBAD grading system had the highest AUROC of 0.96 (with 95% CI of 0.94-0.98) and a maximum Youden index of 0.80; the Wagner grading system showed an AUROC of 0.66 (with 95% CI of 0.61-0.72) and a maximum Youden index of 0.28; the WIfI grading system showed an AUROC of 0.69 (with 95% CI of 0.64-0.74) and a maximum Youden index of 0.33. The DeLong test indicated that the predictive efficacy of the SINBAD grading system for short-term wound non-healing in patients with DFUs was significantly superior to that of the Wagner grading system and WIfI grading system (with Z values of 12.52 and 12.97, P values both <0.05). With amputation as the prognostic outcome, the WIfI grading system had the highest AUROC of 0.89 (95% CI 0.85-0.93) and a maximum Youden index of 0.75; the Wagner grading system showed an AUROC of 0.87 (with 95% CI of 0.83-0.91) and a maximum Youden index of 0.55; the SINBAD grading system showed an AUROC of 0.80 (with 95% CI of 0.76-0.84) and a maximum Youden index of 0.43. The DeLong test showed that the predictive efficacy of both the WIfI grading system and Wagner grading system for amputation in patients with DFUs was significantly superior to that of the SINBAD grading system (with Z values of 3.76 and 2.96, P<0.05). Conclusions The Wagner grading system, SINBAD grading system, and WIfI grading system can all effectively predict the risk of short-term wound non-healing and amputation in patients with DFUs. The SINBAD grading system performs the best in predicting short-term wound non-healing, while the WIfI grading system has an advantage in predicting amputation. Although the Wagner grading system has poorer predictive efficacy for short-term wound non-healing, it still demonstrates good predictive efficacy for amputation. In clinical practice, different grading systems can be used in combination based on the focus of assessment. -
Key words:
- Diabetic foot /
- Amputation /
- Forecasting /
- Wound healing /
- Grading system
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参考文献
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图 1 3种分级系统对400例DFU患者短期创面未愈合的预测效能比较
注：图中直线为参考线；SINBAD为部位、缺血、神经病变、细菌感染、面积、深度,WIfI为伤口、缺血和足部感染,DFU为糖尿病足溃疡
图 2 3种分级系统对400例DFU患者截肢的预测效能比较
注：图中直线为参考线；SINBAD为部位、缺血、神经病变、细菌感染、面积、深度,WIfI为伤口、缺血和足部感染,DFU为糖尿病足溃疡
Table 1. 未愈合组和愈合组DFU患者临床资料比较
组别 例数 性别（例） 年龄（岁, 糖尿病病程[年,M（Q1,Q3）] 空腹血糖（mmol/L, 糖化血红蛋白（%, 创面病程[d,M（Q1,Q3）] 创面愈合时间[d,M（Q1,Q3）] Wagner分级（级, SINBAD评分（分, WIfI分期（期, 男 女 未愈合组 206 111 95 67±11 12（10,18） 8.8±1.3 8.31±0.84 10（4,15） 118（108,125） 3.5±0.5 4.8±1.0 3.0±0.4 愈合组 194 121 73 64±11 11（10,16） 8.6±1.3 8.06±0.79 11（7,15） 65（56,80） 2.9±1.0 3.0±0.8 2.4±0.8 统计量值 χ2=2.96 t=2.66 Z=-2.31 t=2.10 t=3.11 Z=-2.07 Z=-17.76 t=8.25 t=19.78 t=9.87 P值 0.086 0.008 0.021 0.037 0.002 0.038 <0.001 <0.001 <0.001 <0.001 注：DFU为糖尿病足溃疡,SINBAD为部位、缺血、神经病变、细菌感染、面积、深度,WIfI为伤口、缺血和足部感染；按照首次入院3个月时创面是否愈合,将患者分为未愈合组和愈合组；空腹血糖和糖化血红蛋白为入院后24 h内首次检测结果 
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Table 2. 截肢组和未截肢组DFU患者临床资料比较
组别 例数 性别（例） 年龄（岁, 糖尿病病程[年,M（Q1,Q3））] 空腹血糖（mmol/L, 糖化血红蛋白（%, 创面病程[d,M（Q1,Q3）] 创面愈合时间[d,M（Q1,Q3）] Wagner分级（级, SINBAD评分（分, WIfI分期（期, 男 女 截肢组 255 142 113 66±11 12（10,18） 8.9±1.3 8.22±0.84 10（7,15） 108（78,122） 3.6±0.5 4.4±1.1 3.1±0.4 未截肢组 145 90 55 64±11 11（8,16） 8.4±1.1 8.14±0.79 10（6,15） 78（46,80） 2.6±0.9 3.0±1.1 2.1±0.8 统计量值 χ2=1.55 t=2.21 Z=-1.35 t=4.13 t=0.93 Z=-1.36 Z=-2.71 t=14.05 t=11.73 t=16.45 P值 0.214 0.028 0.178 <0.001 0.352 0.174 0.007 <0.001 <0.001 <0.001 注：DFU为糖尿病足溃疡,SINBAD为部位、缺血、神经病变、细菌感染、面积、深度,WIfI为伤口、缺血和足部感染；按照是否截肢（大截肢和小截肢）,将患者分为截肢组和未截肢组；空腹血糖和糖化血红蛋白为入院后24 h内首次检测结果
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Table 3. 不同Wagner分级DFU患者临床资料比较
Wagner分级 例数 性别（例） 年龄（岁, 糖尿病病程[年,M（Q1,Q3）] 空腹血糖（mmol/L, 糖化血红蛋白（%, 创面病程[d,M（Q1,Q3）] 创面愈合时间[d,M（Q1,Q3）] 首次入院3个月时创面未愈合（例） 截肢（例） 男 女 1级 21 21 0 67±12 18（10,24） 9.2±0.6 8.05±0.88 10（7,14） 32（30,56） 0 0 2级 42 13 29 58±10 10（8,10） 8.4±0.8 7.73±0.65 15（10,21） 46（41,69） 2 0 3级 181 113 68 65±10 12（10,16） 8.7±1.4 8.22±0.83 7（5,11） 98（80,118） 101 118 4级 152 83 69 68±11 12（10,18） 8.7±1.3 8.30±0.82 11（10,16） 109（78,125） 101 133 5级 4 2 2 74±9 20（13,24） 9.1±0.9 8.43±1.09 15（11,19） 96（83,146） 2 4 统计量值 χ2=30.11 F=6.96 H=25.48 F=1.55 F=4.40 H=48.23 H=125.30 χ2=73.97 χ2=150.35 P值 <0.001 <0.001 <0.001 0.188 0.002 <0.001 <0.001 <0.001 <0.001 注：DFU为糖尿病足溃疡；无Wagner分级为0级者；空腹血糖和糖化血红蛋白为入院后24 h内首次检测结果；截肢包括大截肢和小截肢
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Table 4. 不同SINBAD评分DFU患者临床资料比较
SINBAD评分 例数 性别（例） 年龄（岁, 糖尿病病程[年,M（Q1,Q3）] 空腹血糖（mmol/L, 糖化血红蛋白（%, 创面病程[d,M（Q1,Q3）] 创面愈合时间[d,M（Q1,Q3）] 首次入院3个月时创面未愈合（例） 截肢（例） 男 女 1分 3 2 1 74±10 10（4,10） 9.6±0.9 7.53±0.12 10（10,15） 56（56,69） 0 0 2分 56 35 21 64±11 10（10,18） 8.4±1.2 7.90±0.91 14（7,15） 57（32,69） 6 2 3分 114 67 47 66±11 12（10,16） 8.6±1.4 8.30±0.72 11（7,16） 72（65,80） 14 70 4分 90 55 35 65±11 12（8,18） 8.7±1.2 8.23±0.86 10（6,11） 98（80,110） 55 60 5分 82 24 58 66±11 12（8,15） 8.9±1.5 8.18±0.92 10（4,14） 122（118,157） 77 74 6分 55 49 6 66±10 11（10,20） 9.0±0.6 8.24±0.68 12（3,21） 118（102,130） 54 49 统计量值 χ2=50.56 F=0.66 H=6.35 F=1.75 F=2.32 H=14.69 H=239.20 χ2=221.10 χ2=133.84 P值 <0.001 0.657 0.274 0.121 0.043 0.012 <0.001 <0.001 <0.001 注：SINBAD为部位、缺血、神经病变、细菌感染、面积、深度,DFU为糖尿病足溃疡；无SINBAD评分为0分者；空腹血糖和糖化血红蛋白为入院后24 h内首次检测结果；截肢包括大截肢和小截肢
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Table 5. 不同WIfI分期DFU患者临床资料比较
WIfI分期 例数 性别（例） 年龄（岁, 糖尿病病程[年,M（Q1,Q3）] 空腹血糖（mmol/L, 糖化血红蛋白（%, 创面病程[d,M（Q1,Q3）] 创面愈合时间[d,M（Q1,Q3）] 首次入院3个月时创面未愈合（例） 截肢（例） 男 女 1期 34 22 12 62±11 10（8,18） 8.5±1.1 7.77±0.85 14（7,15） 46（30,69） 0 0 2期 72 45 27 62±11 12（8,18） 8.3±1.1 8.10±0.76 7（6,15） 80（49,82） 16 10 3期 263 145 118 66±10 12（10,15） 8.8±1.4 8.28±0.83 10（6,14） 108（78,122） 166 216 4期 31 20 11 71±10 18（10,22） 8.8±0.9 8.11±0.79 15（10,21） 120（96,159） 24 29 统计量值 χ2 =2.65 F=5.94 H=6.82 F=3.16 F=4.38 H=13.96 H=98.91 χ2 =83.37 χ2 =187.63 P值 0.449 <0.001 0.078 0.025 0.005 0.003 <0.001 <0.001 <0.001 注：WIfI为伤口、缺血和足部感染,DFU为糖尿病足溃疡；空腹血糖和糖化血红蛋白为入院后24 h内首次检测结果；截肢包括大截肢和小截肢
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