There is a huge disconnect between “real world” wounds (and the patients who have them) and those studied in clinical trials. This disconnect means that the treatments developed may not work for the patients who need them most, and it is used as an excuse for payers not to cover novel therapeutics in their beneficiaries with chronic wounds.

I did my first prospective clinical trial in 1997 and despite having a waiting room packed with patients, had to put ads in the Houston paper and go on radio talk shows to find patients HEALTHY enough with wounds superficial enough to participate in the trial. (Yes, in 1997, before the Internet, people read the newspaper and listened to the radio…)

In 2017, we looked at this in a consortium of clinics being managed by the Serena Group that were also performing several prospective trials in diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). We compared the characteristics of real patients/wounds being treated in those clinics with the exclusion criteria for subjects enrolled in the trials they were performing (see tables).

The real world DFUs were much worse and the real patients were far sicker. The real VLUs were larger and those patients were sicker than the subjects enrolled. Dr. Marissa Carter and I began talking about this disconnect in 2009 when we performed a study demonstrating that the majority of patients seen in wound centers would have been excluded from participation in every prospective clinical trial that had been published over the previous decade.

Check out the podcast about this ongoing problem – an interview with Deb Borfitz. I am grateful for Deb’s interest in this issue.

A news article about the realities of chronic wound research was just released in Clinical Research News.

The non-generalizability of clinical trials is the reason Intellicure has spent the last 25 years developing real world evidence to the point it can be reliably used to understand what really happens to patients with chronic wounds and product effectiveness in the real world.

Real World DFUs vs RCTs
Real World DFUs vs RCTs