Rethinking Clinical Study Protocols To Include Patients With Neuroischemic Wounds

David G. Armstrong DPM MD PhD

We at the Southern Arizona Limb Salvage Alliance (SALSA) wanted to give a heads up to some of the work that has been occupying our time.

We are now working on a piece on neuroischemic wounds with our friends Bill Marston, MD, from the University of North Carolina, and Kel Cohen, MD, an Emeritus Professor from Medical College of Virginia. We are all rather flummoxed that many clinical studies in which we participate — and from which our patients can benefit — systematically exclude patients for whom these treatments may provide the most benefit.

Perhaps 15 years ago, the majority of our patients with wounds primarily had neuropathy with little or no clinically significant peripheral vascular disease.

That has changed. In the developed world, likely half to more than half of our wounded patients with diabetes are neuroischemic. These neuroischemic patients have comparable amputation rates to purely ischemic patients and five-year mortalities that are comparable to many forms of cancer.

We cannot afford to continue to conduct clinical studies that ignore the majority of our patients. Just as is the case in the treatment of cancer, we who care for the diabetic foot need to continue to work to develop specialized treatment centers so our patients with advanced stage wounds have access to the clinical trials and the coordinated care they deserve.

This blog has been adapted with permission from a previous blog that originally appeared at www.toeandflow.com .

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