By Irene Yeh 

September 5, 2023 | When Dr. Caroline Fife stepped into her first clinical trial in 1997, she was met with a waiting room packed with patients. Despite the large number of potential participants, none of them were considered healthy enough for the clinical trial. That was when she realized something was very wrong. 

Today, as the Chief Medical Officer of Intellicure, Dr. Fife advocates for clinical trials that target a general patient population and fights against the barriers that prevent further development in new technology and products. The biggest problem, she finds, is misperceptions of patients’ needs, which influence how manufacturers create products and if payers are willing to support them.  

In the newest episode of the Scope of Things podcast, host Deborah Borfitz speaks with Dr. Fife about the “sorry state” of clinical trials for wound care products, the clinical realities of chronic wounds, and how misconceptions and misinformation are the biggest obstacle of innovation in the wound treatment field. She also discusses the small but hopeful progress that has been made and what more can be done to further improve clinical trials. 

The Problems of Clinical Trials 

Clinical trials are designed to conduct research and determine if certain drugs, products, and other treatment options can help patients with their illnesses and conditions. However, for chronic wounds, clinical trials are not designed this way. 

“Clinical trials will try to exclude as many confounding variables as possible,” explains Dr. Fife. “We’ll conduct trials on patients that don’t reflect the general population, and then the payers will use the exclusion criteria to decide what they will pay for.” 

This exclusion criteria includes prioritizing named diseases, such as diabetic foot ulcers and venous ulcers, and falsely labeling them as common conditions. According to Dr. Fife, when a disease or condition is named, payers and investors are more willing to support manufacturers. As a result, manufacturers focus more on expediting the healing of wounds that will heal anyway than researching the underlying causes behind the chronic wounds, such as nutritional deficiency and medications that halt healing. This is unfortunately perpetuated by “successful and incorrect marketing campaigns.” 

Another criterion is categorizing wounds under a rubric that groups similar wounds into a cohort large enough to constitute as a clinical trial.  

“The FDA wants a clinically identifiable syndrome, and they believe that diabetic foot ulcers and venous ulcers represent one,” says Dr. Fife. “And the big bucket of patients with problems have so many multifactorial contributions that nobody wants to tackle that as a bucket.” 

This exclusion criteria results in the market releasing a product that only helps a small number of patients instead of the general population. As a result, most patients continue to receive noneffective treatment and doctors end up ordering products for their clinics and patients that may not even work. 

“At a superficial glance, all of this technology and the billions of dollars haven’t made much difference,” says Dr. Fife. “Although that’s not completely true, it’s still somewhat true that technology hasn’t solved the problem. A lot of it has to do with the misdirection of technology and the fact that our clinical trials don’t represent what we need.” 

Solutions and Addressing Barriers 

The key to removing these barriers is actually quite simple: continue talking about the issue and advocating for patients. And fortunately, more and more people are beginning to listen. In April 2022, the FDA held a public two-day workshop on wound healing. Dr. Fife and her colleagues spoke about various subjects, including “nameless” wounds, factors that disrupt normal wound healing, creating a successful clinical trial, and roadblocks that prevent successful trials, as well as the CMS’s perspective on wound healing and considerations for local and national coverage determinations. 

Though the FDA has yet to announce any changes, the workshop was able to educate others about the obstacles and challenges that block the progress of treatment for chronic wounds. 

Hope for the Future 

Though progress has only made baby steps, Dr. Fife has hope for the future. “Manufacturers are finally getting the courage to say that their product is so good that they will tackle the wounds that won’t heal on their own.” 

This new confidence indicates that the field is starting to consider patients of all backgrounds instead of filtering them through the exclusion criteria. Furthermore, there have been efforts made to create more generalizable trials by including more comorbid diseases, thus reaching a wider participant pool and expanding treatment options for all patients.  

The process of expanding clinical trial participant pools is taking baby steps, but the compass is starting to point toward a more hopeful future for the clinical trials of wound products and, subsequently, patients of chronic wounds. As manufacturers continue to consider the general population of those afflicted by certain wound conditions and awareness spreads, patients can look forward to better treatment options and more opportunities to partake in clinical trials.