Background: The Second European Consensus Document on Chronic Critical Leg Ischemia defined criteria to predict healing of leg ulcers. These recommendations are based on selected studies but the true performances of the tests proposed are not stated.
Methods: We performed an electronic and manual literature search to retrieve all studies that included the comparison of clinical outcome of cutaneous arterial leg ulcers with ankle (AP) and toe (TP) systolic pressures and we calculated the sensitivity and specificity of these measurements for predicting ulcer healing, according to standard methods for proportions and ROC curve analysis.
Results: Only three studies totalizing 220 legs with cutaneous ulcers (> 50% of the patients had diabetes) fulfilled our predefined criteria. The best performances of the tests (defined as the maximal area under the ROC curve) were obtained for an AP and a TP of 80 mmHg and 30 mmHg, respectively. Our analysis suggests that an AP > or = 80 mmHg predicts a favorable outcome with healing of leg ulcers. This simple test can be performed by the general practitioner. An AP of 50-80 mmHg should be followed by a TP and/or a transcutaneous PO2 measurement in case of unfavorable evolution.
Conclusion: Our study confirms objectively the clinical validity of the criteria (AP < or = 50 mmHg, TP < or = 30 mmHg) supported by the Second European Consensus Document on Chronic Critical Leg Ischemia to predict unfavorable outcome of cutaneous arterial leg ulcers and provides objective performance values for these measurements.