Non-invasive monitoring of lower-limb ulcers via exudate fingerprinting using BIONOTE

Liquid fingerprinting represents a non-invasive and easy method for diagnostic and screening medical tests. BIONOTE is a sensor system including voltammetric liquid sensors consisting of screen printed electrodes controlled by a high stable electronic interface. Bacterial colonization of lower-limb ulcers gives a huge production of volatile and semi volatile compounds which could modify the electrochemical pattern of ulcer's exudate. The main goal of this study was to test the electrochemical fingerprinting of biological samples in solution in term of diagnostic accuracy and of feasibility when applied to the study of lower-limb ulcers, where the biological sample consists of ulcer's exudate. To this scope, BIONOTE's liquid sensors have been tested in a single-center pilot study. A total number of 30 clinical parameters have been collected for the medical characterization of each patient. A data fusion of the clinical parameters and of the BIONOTE data have been successful in discriminating ulcers evolution. In particular, the correct discrimination percentage between the ulcer analyzed at the first and at the second clinical evaluation (after therapy) was of 75%, 90% and 97.5% when based on clinical data, BIONOTE data and data fusion respectively. The consistency of BIONOTE ability in ulcer monitoring has been also confirmed by a good sensor's prediction ability with respect to three key-parameters: Leg Ulcer Measurement Tool (LUMT), peripheral oxygen saturation of hemoglobin (SpO2), Transcutaneous oxygen pressure (TcPO2).