Diffuse near-infrared spectroscopy prediction of healing in diabetic foot ulcers: a human study and cost analysis.

Wound size reduction has been the standard benchmark for determination of efficacy for diabetic ulcer treatments but due to interclinician error and difficulty measuring irregular wound shapes, this method is unreliable with a positive predictive value of less than 60%. Diffuse near-infrared spectroscopy (DNIRS) uses 70-MHz modulated light in the diagnostic window (650-900 nm) noninvasively to quantify levels of oxy- and deoxy-hemoglobin in the wound bed, which when measured over time, can show a trend toward or away from healing based on the changes in oxy-hemoglobin concentration from week to week. In this study, DNIRS was used to monitor 24 human diabetic foot ulcers longitudinally over the course of 20 weekly or biweekly measurement sessions. In just 4 weeks, the DNIRS system has an 82% positive predictive value (sensitivity of 0.9 and specificity of 0.86; p < 0.002). These data indicate that it could be possible to predict healing in 4 weeks using DNIRS, which can provide objective guidance toward the continuation of costly treatments. Discontinuing ineffective treatments after 4 weeks could have potentially saved over $12,600 per patient, based on the treatment regimen of patients in this study.