A Paradigm Shift in Wound Care Research: Advancing Beyond the COVID-19 Crisis

Challenge: Clinical trials are the mainstay for advanced treatment for chronically ill patients. In wound care, patients often present with complex etiologies, have had little or no success with standard of care and are usually underinsured; some may even have waited a long time to qualify for the study. The abrupt clinical hold caused by COVID-19 left many patients without care, leaving them at risk of complications, infection and sepsis.

Innovation: There is an opportunity to rethink how research studies should be conducted. Rapid advances in technology, coupled with proliferation of telehealth modalities, sensors, wearable and connected devices have paved the way for decentralized clinical trials (DCT). DCTs represent a paradigm shift, enabling remote dispensing of investigational product (IP), clinical assessments and data collection.

Approach: The challenge centers around building the infrastructure to operationalize DCTs. A wide range of digital technologies need to be developed and qualified before implementation. Data control, integrity, security and access are among the top concerns. The technology must comply with data privacy regulations while ensuring usability and data accessibility. At the height of the pandemic, a comprehensive solution was born to enable virtual patient-provider engagement ‚±°. The solution includes a video conferencing, securing messaging and a patient app built on artificial intelligence (AI) to streamline data collection and facilitate remote monitoring. The clinical workflow enables the provider to review, accept or revise automated wound recognition and the resultant measurements. The entire platform is HIPAA, GDPR, and 21 CFR Part 11 compliant.

Conclusion: The technology has the potential to enable hybrid or full DCTs in wound care, minimize recruitment and retention barriers without compromising study design, quality or data integrity. With the acceleration of technological advances and growing support from regulatory agencies, DCTs show promise for transforming wound care research.

Trademarked Items (if applicable): eKare Telehealth, eKare, Fairfax, Virginia

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