Tag: Clinical Research

Wound Care Clinical Trials: Setting the Record Straight

A recent article by Kaiser Health News misquoted me as saying that we enroll only “healthy” patients in our clinical trials. At moments like this, one feels that something has been overlooked. One of my research coordinators, recalling the serious adverse events (SAEs) of the previous week said, “The only patients sicker than ours are underground.”

 

Anyone who has ever spent more than ten minutes in a wound clinic knows that our patients are anything but healthy. Our acuity levels mirror the dialysis and transplant units. We check the obituaries when our patients miss appointments.

The Chronic Wound Epidemic

Although it should be, this is not just a minor annoyance. A procession of anecdotal observations on the failing health of the wound care space—in a time of flux and disarray—is neither enlightening nor supportive. The article itself focuses on the use of expensive products in wound care. In comparison to other medical specialties, such as oncology or cardiology, our products are inexpensive and cost effective. Chronic wounds are an unacknowledged epidemic. The huge increase in spending has less to do with the cost of wound care products than it does to the staggering number of patients who need them. Why is wound care research so poorly funded? The National Institutes of Health (NIH) does not even have a wound care division … read more

Double-Blinded Clinical Trials

A Gift from the Devil’s Grandmother

 

By Thomas E. Serena MD, FACS, FACHM, FAPWCA

Editor’s note:This blog post is part of the WoundSource Trending Topics series, bringing you insight into the latest clinical issues and advancement in wound management, with contributions by the WoundSource Editorial Advisory Board.

 

I do not know the origin of the phrase “…a gift from the devil’s grandmother.” I first read it in Einstein’s letters to Schrödinger. Einstein employed the phrase to describe his fear of failing to find a unified theory of relativity and quantum physics. The problem appeared unsolvable.

 

A similar gift in the field of clinical trial research in wound healing appeared on my doorstep recently. I started my research career conducting double-blinded pharmaceutical trials. After a string of failures, I convinced myself that advanced therapy in chronic wounds was doomed; however, cellular and/or tissue-based products (CTPs) entered the market with encouraging results, brightening my spirits. To date, our cooperative group of investigators has published more than a dozen trials demonstrating the efficacy of CTPs in the treatment of diabetic and venous ulcers … read more