AIM: 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. METHODS: 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). RESULTS: 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. CONCLUSION: 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.

Amsterdam Movement Sciences Rehabilitation and Development program Amsterdam The Netherlands

Amsterdam UMC University of Amsterdam Department of Rehabilitation Medicine Amsterdam The Netherlands

Clinical Diabetes Center Elisabeth Hospital Essen Essen Germany

Department of Biosciences and Medicine University of Surrey Surrey UK

Department of Diabetes Faculty of Life Sciences and Medicine King's College Strand London UK

Department of Medicine and Surgery Endocrine Metabolic and of Transplantation University of Pisa Italy

Diabetic Foot Clinic and Diabetic Department King's College Hospital London UK

Faculty of Medicine Oporto University Porto Portugal

Lewisham and Greenwich NHS Trust Foot Health Service London UK

MEDCIDS Departamento de Medicina da Comunidade Informação e Decisão em Saúde Faculty of Medicine of the University of Porto Porto Portugal

Medical Department of the 1st Faculty of Medicine and Military University Hospital Prague Diabetes Center and Foot Clinic Czech Republic

Portuguese Red Cross School of Health Lisbon Lisbon Portugal

Retired Physician Nottingham University Hospitals NHS Trust UK

Steno Diabetes Center North Denmark Aalborg University Hospital Aalborg Denmark

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