Reapplix today announced that it has been informed by the Trial Steering Committee for the ongoing LeucoPatch® Randomized Controlled Trial (ClinicalTrials.gov NCT02224742) that a planned interim analysis has been performed. The purpose of the planned interim analysis was to re-estimate the sample size (up to 352 patients if needed) or to stop for futility. Following the planned interim analysis, Reapplix has been informed that the trial will continue to the originally estimated sample size of 250 participants.
This large scale Randomized Controlled Trial is being conducted in up to 35 centres in UK, Sweden and Denmark. The aim of the Trial is to demonstrate whether the application of LeucoPatch® when used in addition to usual care in a multidisciplinary diabetes foot clinic setting, is superior to usual care alone with regard to complete healing of hard-to-heal diabetic foot ulcers. The study will also provide information on reduction in pain, decrease in ulcer area, amputations, well-being, costs and other clinical outcomes.
Reapplix are providing funding for this trial, which is being run independently by the Sponsors, Nottingham University Hospitals NHS Trust.