This study aims to compare skin perfusion pressure measurements (SPP) at midfoot and below knee level performed with a novel laser Doppler flowmetry (LD) probe with a reference method based on photo plethysmography (PP). It includes 40 patients referred with known or suspected peripheral arterial disease. The SPP was performed with both devices. Blinded re-interpretation of the SPP measurements was carried out by three observers and a consensus quality score was provided for each measurement. SPP >40 mmHg was considered a clinically relevant cut-off. This study evaluates a total of 48 paired measurements of the midfoot and 54 below knee. The two methods agreed in overall diagnostic classification in 80 of 102 measurements (78%) with both methods showing SPP ≥40 mmHg in 21 cases, and both methods showing SPP <40 mmHg in 59 cases. Of the 22 participants with disagreement (22%) in overall classification, 15 had measurements within the range of 30-50 mmHg, and 7 with a clinically relevant disagreement with one device showing SPP <30 mmHg and the other ≥40 mmHg. Analysis of inter observer variation for the LD readings showed an intraclass correlation coefficient of 0.880 (95% CI: 0.807 to 0.929, p- value <0.05) at midfoot, and 0.933 (95% CI: 0.894 to 0.959, p-value <0.05) at below knee level. The novel probe based on LD showed good correlation with PP in absolute pressures, sufficient agreement in overall disease classification as well as good to excellent reliability in terms of inter observer variation.
Keywords: Blood circulation; Laser-Doppler flowmetry; observer variation; perfusion; photopletysmography.