The Gap Between Clinical Trials and Real-World Chronic Wound Patients

All of us in wound care are struggling to understand the rationale for limiting patients to 4 applications of a skin substitute when the patients in the clinical trials used to rationalize “medically necessary” products (Group 2) were both healthier than “real world” patients and were given 10 or more applications to achieve closure. 

Caroline Fife, M.D. highlights a concerning discrepancy between the characteristics of patients with chronic wounds in real-world settings and those selected for clinical trials. She stresses the potential implications this has for patient access to FDA approved treatments that have the potential to save limbs and lives.  I think this is particularly apropos with the impending LCDs in CGS, First Coast, and Novitas. 

Even if one were to ascribe to the theory that CMS does not have healing as it primary goal and instead is focused on cost containment, the costs of amputations and complications are likely far higher than more treatments.  Once again Caroline’s blog is essential reading…

Read Caroline Fife, M.D.’s Blog The Realities of Chronic Wound Research here