A Brief Patient-Reported Symptom Burden Scale for Diabetic Foot Ulcer: Development and Validation

Diabetic foot ulcer (DFU) is associated with substantial morbidity and symptom burden that may be insufficiently captured by wound-centred documentation. This study developed and psychometrically evaluated a brief DFU-specific patient-reported symptom burden scale. A two-phase design was used. Phase I generated and refined items through literature review, semi-structured interviews, Delphi consultation, and pilot testing. Phase II was a cross-sectional validation study in a tertiary hospital in China, using a development sample (n = 160) for item analysis and exploratory factor analysis and a validation sample (n = 200) for confirmatory factor analysis, construct validity testing, and reliability assessment. The final scale included 23 items across six clinically interpretable domains and assessed symptom frequency, severity, and distress. The six-factor structure explained 64.398% of variance and showed acceptable model fit (χ²/df = 1.987). Content validity was high (I-CVI = 0.875-1.00; S-CVI/UA = 0.923; S-CVI/Ave = 0.990). Total scores correlated moderately with DFS-SF scores (r = 0.630). Reliability was satisfactory (Cronbach's α = 0.840; split-half = 0.923; ICC = 0.983). The scale may support systematic symptom monitoring and symptom-focused DFU care.