John Macdonald, MD, University of Miami Department of Dermatology, Miami, Florida, USA
Tjip van der Werf, MD, University Medisch Centrum Groningen, Groningen, Netherlands
Richard Phillips, MD, Komofo Anokye Teaching Hospital, Kumasi, Ghana
Annick Chauty, MD, Centre de Diagnostic et de Traitement de L’Ulcere de Buruli, Pobe, Benin
To validate a digital wound assessment system's efficacy in documenting and securing reliable, real-time data for clinical trials in remote sites where trial stakeholders are accessing information from a range of locations elsewhere in the world.
A World Health Organization study of the efficacy of treatments for Buruli ulcer in Africa is taking place at four sites in Ghana, and one in Benin, with the target set at a total of 332 study subjects with PCR-confirmed disease. The data is being analyzed by key researchers in France, The Netherlands, Switzerland and the USA. Study organizers recognized that undertaking wound assessments in such remote areas would introduce the risk of inconsistent assessment information and the loss of critical data. The sponsors therefore implemented a digital wound assessment system to gather accurate data (wound area) and images. Researchers were interviewed to gauge the reliability and security of the wound assessment information, to validate the efficacy of the tool in capturing, storing, and securely sharing the required data.
Results / Discussion:
The investigators reported that the use of digital wound assessment provided reliable, consistent wound status information and images. This supported their ability to effectively monitor the study’s progress, obtain clinically meaningful information, obtain data instantly, and document the evidence required to publish repeatable study findings.
Digital wound assessment data centralized on a secure Internet server ensures that a reliable, timely record of wound status is available to stakeholders of clinical trials, even when the sites are in remote parts of the world.