Røikjer Johan, Monteiro-Soares Matilde, Walton Daina, Iacopi Elisabetta, Jirkovska Jarmila, Edmonds Michael, Trocha Anna, Jeffocate William, Bus Sicco
Steno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark.
Portuguese Red Cross School of Health-Lisbon, Lisbon, Portugal.
Diabet Med. 2025 Jan;42(1):e15443. doi: 10.1111/dme.15443. Epub 2024 Sep 28.
A diabetes-related foot ulcer (DFU) is a major risk factor for lower-extremity amputation (LEA). To help clinicians predict the risk of LEA in people with DFU, the Diabetic Foot Risk Assessment (DIAFORA) system was developed but has never been externally validated.
In this study, 317 people presenting with a new DFU were included. At baseline, participants were grouped into three groups based on their DIAFORA score: low-risk (<15), medium-risk (15-25), and high-risk (>25). Participants were followed until healing, LEA, death, or at least 3 months. Discriminative accuracy was evaluated using sensitivity, specificity, likelihood ratios (LRs) and the area under the curve (AUC).
All 317 participants completed at least 3 months of follow-up for a median duration of 146 days, during which 12.6% underwent minor amputation and 2.5% major amputation. People in the low- and medium-risk categories had major amputation rates of 0.9% and 2.1%, respectively, and negative LR of major LEA of 0.10 and 0.38, respectively, while the people in the high-risk category had an amputation rate of 25.0% and a positive LR of 12.9. The DIAFORA risk groups had a sensitivity of 75.0% and a specificity of 65.7%, with a corresponding AUC of 0.78 (95% CI 0.68-0.87) for the prediction of major LEA.
The DIAFORA score is a useful tool for risk stratification of people presenting with a newly occurred DFU, with the external validation presenting results similar to those presented in the original study. The DIAFORA score may guide clinicians towards more individualized DFU treatment regimens.
糖尿病相关足部溃疡（DFU）是下肢截肢（LEA）的主要危险因素。为帮助临床医生预测DFU患者的LEA风险，开发了糖尿病足风险评估（DIAFORA）系统，但从未进行过外部验证。
本研究纳入了317例新发DFU患者。在基线时，根据DIAFORA评分将参与者分为三组：低风险（<15）、中风险（15 - 25）和高风险（>25）。对参与者进行随访，直至伤口愈合、发生LEA、死亡或至少3个月。使用敏感性、特异性、似然比（LRs）和曲线下面积（AUC）评估判别准确性。
所有317名参与者至少完成了3个月的随访，中位随访时间为146天，在此期间，12.6%的患者接受了小截肢，2.5%的患者接受了大截肢。低风险和中风险类别的患者大截肢率分别为0.9%和2.1%，大LEA的阴性似然比分别为0.10和0.38，而高风险类别的患者截肢率为25.0%，阳性似然比为12.9。DIAFORA风险组预测大LEA的敏感性为75.0%，特异性为65.7%，相应的AUC为0.78（95%CI 0.68 - 0.87）。
DIAFORA评分是对新发DFU患者进行风险分层的有用工具，外部验证结果与原始研究结果相似。DIAFORA评分可指导临床医生制定更个体化的DFU治疗方案。
