Dr. Brian Callaghan to lead new study on treatment for painful diabetic neuropathy

Painful diabetic neuropathy (PDN) affects about 1 in 5 people with diabetes.  Researchers aren’t sure why some cases of diabetic neuropathy are painful, while others are not.  It is a debilitating condition that is expected to become more common as the incidence of diabetes continues to increase.

There are several treatment options available — oral, topical, and behavioral — but little evidence comparing the three. 

“We want to give doctors an idea of how to treat painful diabetic neuropathy based on data, not on previous practice habits,” said Brian Callaghan, M.D., M.S., Eva L. Feldman, M.D., Ph.D., Professor of Neurology and Principal Investigator for the project.  “For instance, doctors are most likely to prescribe oral medication because that’s what doctors do.  Topical medications aren’t studied as much, and behavioral interventions are often not thought about at all.  Maybe that’s because they don’t work well, or maybe that’s because they haven’t been tried.  That’s what we want to determine.”

PCORI is making that investigation possible with a multimillion-dollar funding award for patient-centered comparative clinical effectiveness research, in this case, comparing interventions for diabetic neuropathy in real-world care settings.  Dr. Callaghan’s team will seek to answer three questions:

• Which modality should doctors begin with when treating diabetic neuropathy?
• If the first treatment option fails, should they switch to another method or double down on the initial treatment?
• What factors can best predict which patients will respond best to which intervention?

“This research project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other health care stakeholders, but also for it in real-world settings," said PCORI Executive Director Nakela L. Cook, M.D., MPH. “It has the potential to answer an important question about treatment for painful diabetic neuropathy and fill a crucial evidence gap to help patients and those who care for them make better-informed healthcare decisions that reflect their needs and preferences. We look forward to following the study’s progress.”