The FDA's Take on Diabetic Foot Ulcer Treatments

During the last 10 years, the United States FDA has approved only a few new treatments for diabetic foot ulcer (DFU). Amarex’s Kazem Kazempour, PhD, believes careful study design is required to demonstrate efficacy of new wound healing treatments. In this video, Kazempour explains why it is so difficult for new therapies to be approved. 

Transcript

This is fairly complex issue. There are many factors in responding to your question. Really, it's multi-factor issue. Part of the challenge is that the regulatory agency, FDA, has a very clear, and at the same time, very narrow definition of wound healing. That is 100% wound closure with no drainage or no need for any dressing.

That is called wound healing. Time to 100% closure. 100% closure is what I define, that no drainage, no need for any dressing. Part of the challenge is that the FDA has this definition. It is generally fairly difficult to demonstrate the efficacy using this definition of wound closure.

If all the noises and all other factors affecting the wound closure are not considered at the design stage. When the trial is over, it is going to be very hard to show that, to demonstrate the efficacy of the treatment.

Investigators and study sponsors, really, they should work very hard in designing their clinical trials in a way that, as much as they can, to reduce the noise, so that the signal can be observed and presented to regulatory agency, with proper statistical power and necessary control over the patient population. I will talk more about that one.

From that angle, due to all these factors, it is difficult to show the efficacy.