Prevention of Posttraumatic Contractures with Ketotifen (PERK)
Technical Report,30 Sep 2015,29 Jun 2018
University of Calgary Calgary, Alberta Canada
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All goals have been achieved in this Clinical Trial Development Award to develop the infrastructure to complete a multicenter randomized clinical trial. We have secured funding for a trial from the Department of Defense Contract No. W81XWH-17-1-0665. We have received approval from the Food and Drug Administration, Human Research Protections Office, and Health Canada to conduct the study. Seventeen centers across Canada and the United States will recruit for the trial. Training sessions for these centers were completed and startup funds to finalize institutional review board applications have been awarded. Contracts have been signed with organizations to support central core functions including procurement, packaging, and distribution of study medication and placebo across North America database and study management for randomization and coordination of medication distribution image archiving outcome measurement tool validation study monitoring and safety committees and centralized trial support for contractsregulatory, budget, and recruitmentfollow updata entry. Knowledge translation has included reports of this work in University and Health Services media and through the annual program report by the Peer Reviewed Orthopaedic Research Program.
- Medicine and Medical Research