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Factors impacting the success of patient recruitment in recalcitrant venous leg ulcer clinical trials First Author: Melody Boyd Authors: Melody Boyd, MSc Factors Impacting the Success of Patient Recruitment in Recalcitrant Venous Leg Ulcer Clinical Trials Background Chronic ulceration caused by vascular insufficiency is a common cause of morbidity and mortality in adult and elderly populations. It is estimated that approximately 600,000 people seek treatment for venous leg ulcers (VLUs) annually in the U.S.,1 with a subset of these patients being afflicted with recalcitrant VLUs. Several randomised clinical trials have compared different types of products in VLUs compared to compression therapy. Practical clinical trial designs, along with optimized patient recruitment and retention strategies are critical to the success of trials in this patient population. Objective A prospective Phase III, multi-centre, double blind, randomised, placebo controlled clinical trial is currently being conducted to evaluate the safety and efficacy of a topical wound care product compared to four layer compression for the treatment of recalcitrant VLUs. Methods Subjects with chronic VLUs are being enrolled into the study to evaluate the safety and efficacy of a topical wound care product designed to actively stimulate repair in persistent chronic wounds. This multi-centre trial was designed to enrol approximately 200 subjects, with sites in Canada, the U.S. and the U.K. Subjects are randomized into three groups, standard four-layer compression therapy, the treatment group with either active or placebo and compression therapy. Conclusion Numerous challenges have been encountered recruiting patients into this trial and site specific recruitment strategies were employed at sites in all three jurisdictions. Results from successful and unsuccessful strategies will be presented including the overall cost per actual randomised patient into the study. |
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