Painful Diabetic Peripheral Neuropathy Research Study

Researchers at the Low Country Pain Center are partnering with individuals diagnosed with nerve pain in the legs and feet from diabetes to evaluate potential treatment possibilities. Join our study and receive up to $2950 with possible transport and dependent care reimbursement.

Fast Facts

diagnosis of diabetes with stable treatment

nerve pain in legs/feet for 6+ months

18 Years and Older

Compensation Provided

Multiple locations available

Study Background

The Early Phase Pain Investigation Clinical Network (EPPIC-Net) is an NIH HEAL initiative that aims to enhance the treatment of acute and chronic pain to reduce opioid dependence by accelerating early-phase clinical trials of non-addictive treatments for pain.

This research study, the Novaremed study, is a 22-week clinical study investigating a new investigational medication for the treatment of Painful Diabetic Peripheral Neuropathy, which is pain in the lower extremities (feet) and can manifest as burning, stabbing, tingling, and numbness of one or both legs and feet. If you have suffered from PDPN for 6 months or longer, you may be eligible to participate in the study.

Your participation may help researchers improve treatment approaches for PDPN. Further research today and join our compensated study!

Participating institutions:

  • Clinical Inquest Center (Beavercreek, OH)
  • Columbia University (Manhattan, NY)

  • Healthcare Research Network (Flossmoor, IL)

  • Healthcare Research Network (Hazelwood, MO)

  • Johns Hopkins University (Baltimore, MD)

  • Low Country Pain (Orangeburg, SC)
  • Massachusetts General Hospital (Boston, MA)

  • Mount Sinai (Manhattan, NY)

  • Nerve and Muscle Center of Texas (Houston, TX)

  • Northwestern University (Chicago, IL)

  • SIMED Health (Gainesville, FL)

  • South Lake Pain (Clermont, FL)

  • University of California, San Diego (San Diego, CA)

  • University of Florida (Gainesville, FL)

  • University Of Kansas Medical Center (Kansas City, KS)

  • University of Maryland, Baltimore (Baltimore, MD)
  • University of Pittsburgh (Pittsburgh, PA)

  • University of Rochester (Rochester, NY)

  • University of Utah (Salt Lake City, UT)

  • University of Washington (Seattle, WA)

  • University of Wisconsin, Madison (Madison, WI)

  • Virginia Commonwealth University (Richmond, VA)

Additional Information

The purpose of this research study is to investigate the safety and efficacy of a once-daily oral study medication to treat pain in the legs and feet directly related to nerve damage caused by diabetes.

You may qualify for this study if you meet the following criteria.

Inclusion Criteria:

  • 18 years of age and older
  • Diagnosis of diabetes with stable treatment
  • Decreased sensation in the lower extremities near or at the ankles (numbness)
  • Neuropathic symptoms (Pain, tingling, numbness and or burning sensation in the feet and or lower extremities)
  • Willing to give up your current pain medication for this study
  • Willing to stop illicit drug use during the study, including marijuana
  • Women with one of the following:
    • No childbearing potential or menopausal
    • Abstinent from heterosexual intercourse
    • Willing to use 2 forms of birth control during the study
  • Men with one of the following:
    • Incapable of fathering children
    • Abstinent from heterosexual intercourse
    • Willing to use 1 form of birth control during the study

Exclusion Criteria:

  • Alcohol/substance dependence
  • Moderate or severe kidney disease
  • History of heart failure, low potassium, heart attack, clinically significant heart disease, stroke
  • Have participated in 4 or more other studies for an investigational pain drug
  • Peripheral neuropathy (nerve pain) caused by something other than diabetes
  • Idiopathic neuropathy (pain in your legs/feet of an unknown cause)
  • Use of other investigational drugs in the past 3 months

This study takes approximately 4 months to complete. You will receive the study medication every day for 13 weeks. There will be 7 in-person visits at the clinic that will happen every 3 weeks. Most of the visits will take about 2-3 hours each time. The first will be the longest and will last about 4 hours.

Visits include:

  1.   Blood tests
  2.   Blood collection for biobanking (optional)
  3.   Physical Exam
  4.   Vital Signs
  5.   Answer questionnaires on a mobile app daily
  6.   Provide a urine and stool sample
  7.   Wear an Actigraphy device (like FitBit)
  8.   Drug test
  9.   Pregnancy test
  10.   Electrocardiogram (ECG)

Compensation is provided up to $2950 for your time, and reimbursement is available for transportation and dependent care.

There is no cost for you to participate in this study.