Brian M Schmidt, Cathie Spino, Teresa L Z Jones, Michael Conte, Gayle Gordillo, Geoffrey Gurtner, Crystal Holmes, Cathy Martin, Fleur Maturo, Kourtney Noll, Steven Thelen-Perry, Nazila Mirzadjahromi, Chandan K Sen, Rodica Pop-Busui
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引用次数: 0
Abstract
Objective: Platform studies are an innovative clinical trial design to evaluate multiple potential therapies simultaneously using a master protocol framework for more rapid discovery of critical new disease-modifying therapies. Initially pioneered in cancer clinical trials, platform studies have more recently been adopted for new vaccine trials and other disease states. This approach has not been used for biomarker(s) validation.
Approach: We present the development and successful implementation of a master protocol for a platform study in the National Institute of Diabetes and Digestive and Kidney Diseases Diabetic Foot Consortium (DFC) that concomitantly tests multiple biomarkers that could be used to predict diabetic foot ulcer (DFU) healing outcomes in people with DFUs.
Results: This flexible master protocol, allowing the study of multiple biomarkers in a perpetual manner, designed to be inclusive of a broad spectrum of people with DFUs operating under the mantra "No DFU Goes Unstudied" successfully collects participant data and biospecimens for biomarker development and validation in a standardized manner across multiple DFC sites.
Innovation: Integrating multiple biomarkers with a rich database of participants' clinical characteristics, patient-reported outcomes, and standard of care practices at various sites collected longitudinally over 52 weeks following a pragmatic approach and thus relevant to people with DFU as seen in today's daily practice, enable their subsequent implementation at the point of care to guide timely personalized DFU management decisions.
Conclusion: Leveraging this robust platform will help to identify new therapeutic targets and design and conduct effective interventional clinical trials for DFU wound healing, which could inform the standards of care.
期刊介绍：
Advances in Wound Care rapidly shares research from bench to bedside, with wound care applications for burns, major trauma, blast injuries, surgery, and diabetic ulcers. The Journal provides a critical, peer-reviewed forum for the field of tissue injury and repair, with an emphasis on acute and chronic wounds.
Advances in Wound Care explores novel research approaches and practices to deliver the latest scientific discoveries and developments.
Advances in Wound Care coverage includes:
Skin bioengineering,
Skin and tissue regeneration,
Acute, chronic, and complex wounds,
Dressings,
Anti-scar strategies,
Inflammation,
Burns and healing,
Biofilm,
Oxygen and angiogenesis,
Critical limb ischemia,
Military wound care,
New devices and technologies.
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