3 November, 2020
Promore Pharma AB (publ) undertook an 18-site clinical trial to further prove the efficacy and safety of ropocamptide (LL-37) for patients with hard to heal (HTH) venous leg ulcers (VLUs). They utilized SilhouetteLite+ on iPads to gather consistent data across their sites, and the data was securely stored in the SilhouetteCentral database hosted on Microsoft’s cloud computing service, Azure. Promore Pharma also utilized ARANZ Medical’s data quality services and independent assessors to review the data they captured to ensure the data they had captured was not biased.
“At each site, we had the SilhouetteLite+ app on iPads, which enabled all of the different clinicians to easily gather the images and data in exactly the same way. It was crucial in this study to have the data collected in reliable, consistent ways from all the sites and all of the different clinicians who were doing the assessments, and Silhouette enabled us to do that. The ability to have the data checked and validated by an independent assessor was also key to our decision. This study was designed to address whether ropocamptide improves VLU healing rates and there was no room for any errors in the way we gathered or reported the data. The ARANZ Medical team was great to work with and the Silhouette system was easy to use and provided accurate information – both of these elements played important roles in the success of this study.” Chief Scientific Officer, Prof. Margit Mahlapuu