“Chronic non-healing wounds cost more than heart-failure and have a higher mortality rate than breast or colon cancer but there is no comparable investment in research.” – Dr. Caroline Fife, executive director of the US Wound Registry
- More than 15 percent of Medicare beneficiaries suffer from non-healing wounds, which is a higher percentage than the number affected by heart failure.
- The federal government provides the same amount of funding for wound care research as it does for Lyme disease, which affects a much smaller percentage of people.
- Currently, the only source of funding for this important research comes from the manufacturers of cellular products, which means research – while high quality - tends to be primarily focused on getting products to market.
- The FDA’s new openness to real world evidence can have a important impact in the wound care space, where patients in the clinical trials that are performed don’t tend to “look” like the real patients who show up in wound care clinics, who are generally older, sicker and less compliant with treatment regimens than those enrolled in clinical trials. As we transition to a US healthcare system that is focused on value-based care, understanding patterns of care, comparative effectiveness of wound care interventions in a real-world setting, will be essential to improving care moving forward. While randomized clinical trials may be more convincing to regulators, it is real world data that is most convincing to practitioners – as it represents the people that sit in their waiting room rather than the carefully selected populations in clinical trials.
- Sources of peer-reviewed wound care research include: