The Disconnect with Diabetic Foot Ulcers

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 the disconnect between the FDA's definition of wound healing and the reality of DFUs.

Transcript:

You are right, some consider this definition of wound closure by FDA as part of the problem, which due to the difficulty, as I mentioned earlier, it may be one of them, because as I said, 100 percent wound closure with no dressing requirement, no drainage, during the pre‑specified time, it is challenging, no doubt. It has been challenging and it is a challenging one.

Currently, that is the clear definition. That is the rule of game to play. All the sponsors, in order to be able to approve a new product, they have to follow the rule. There is no exception whatsoever.

From a regulatory and statistical analysis point of view speaking, if the wound reduces, as I mentioned, the size, say three centimeters square to .05 centimeter square, the sponsor cannot claim the treatment is working. Although it may be that, yes, the wound size reduced by 99.5 percent, but that is not enough from the approval.

The clear factor is time to wound closure. That's another main factor. One of the things it's there is that, most of the clinical trials are between 12 to 24 weeks in duration. Let's say 16 weeks for the sake of this discussion. With certain wounds, they simply are not going to heal 100 percent during this pre‑specified time. 16 weeks, for example.

All it depends on the size of wound, the depth of wound, the severity of wound, and so many factors involved in the wound closure. All these factors, as I said, will create noise. Sponsors designing their trial by taking all these factors. Which when you do that, it increases the size of the study.

They may be able to go to FDA and get approval when all these factors are controlled. You cannot really get rid of all of them, but you can control them and be able to present it to regulatory agency for approval.