Evaluating the prognostic performance of bedside tests used for peripheral arterial disease diagnosis in the prediction of diabetic foot ulcer healing.

Introduction: Diabetic foot ulceration (DFU) is a common and challenging complication of diabetes. Risk stratification can guide further management. We aim to evaluate the prognostic performance of bedside tests used for peripheral arterial disease (PAD) diagnosis to predict DFU healing.

Research Design And Methods: Testing for Arterial Disease in Diabetes (TrEAD) was a prospective observational study comparing the diagnostic performance of commonly used tests for PAD diagnosis. We performed a secondary analysis assessing whether these could predict DFU healing. Follow-up was performed prospectively for 12 months. The primary outcome was sensitivity for predicting ulcer healing. Secondary endpoints were specificity, predictive values, and likelihood ratios for ulcer healing.

Results: 123 of TrEAD participants with DFU were included. In 12 months, 52.8% of ulcers healed. The best negative diagnostic likelihood ratio (NDLR) was observed for the podiatry ankle duplex scan (PAD-scan) monophasic or biphasic with adverse features(NDLR 0.35, 95% CI 0.14-0.90). The highest positive likelihood ratios were observed for toe brachial pressure index of ≤0.2 (positive diagnostic likelihood ratio (PDLR) 7.67, 95% CI 0.91-64.84) and transcutaneous pressure of oxygen of ≤20 mm Hg (PDLR 2.68, 95% CI 0.54-13.25). Cox proportional hazards modeling demonstrated significantly greater probabilities of healing with triphasic waveforms (HR=2.54, 95% CI 1.23-5.3, p=0.012) and biphasic waveforms with non-adverse features (HR=13.67, 95% CI 4.78-39.1, p<0.001) on PAD-scan.

Conclusions: No single test performed well enough to be used in isolation as a prognostic marker for the prediction of DFU healing.

Trial Registration Number: NCT04058626.