Abstract
The purpose of this review is to raise awareness, examine the challenges faced by wound care researchers and explore opportunities for potential improvements. Chronic wounds are associated with significant morbidity and mortality, and they represent a major medical and financial burden. Despite this, no new therapy has received FDA efficacy approval for the treatment of chronic wounds since 1997. Previous preclinical studies using animal models did not translate to human wounds due to inherent limitations of experimental models, variability in assessment methods and overall experimental design. Clinical trials continued to be challenged by the balance of the inclusion and exclusion criteria, the high cost and time expenditure of the trials, and the constraint of a single FDA-acceptable outcome of complete wound closure. Wound research faces multiple challenges in both pre-clinical and clinical research that slowed progress and development of efficacious therapies. Solutions to such challenges will provide new opportunities for improved study design in the future.
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