Adults 18 years and older may qualify for a study evaluating investigational treatment options for diabetic peripheral neuropathic pain (DPNP), also called diabetic nerve pain in the legs and feet. Participants in this study must have diabetes and symptoms of painful diabetic neuropathy.
Diabetic Peripheral Neuropathy
Age Range:
18
Gender:
Male and Female
Location:
New Port Richey
About the Study
Diabetic peripheral neuropathic pain is a painful nerve condition that can occur in people with diabetes. It commonly affects the lower extremities in a symmetrical pattern and may cause burning, tingling, numbness, or pain that interferes with daily activities and quality of life.
Researchers are studying investigational treatments in a chronic pain master protocol to better understand whether these treatments may help reduce pain severity and improve daily functioning in adults with DPNP. Pain and physical functioning in this study are measured using the Brief Pain Inventory–Short Form Modified (BPI-SFM).
This study includes a screening period followed by randomization and a double-blind treatment period. Participants may receive either an investigational study treatment or placebo, depending on the study arm they are assigned to.
Qualifications
You may be able to join if you:
- Are 18 years of age or older.
- Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.
- Have diabetic peripheral neuropathy affecting the lower extremities in a symmetrical pattern for at least 6 months.
- Meet neuropathy screening criteria based on the Michigan Neuropathy Screening Instrument.
- Have an HbA1c below 11% and have been on a stable diabetes treatment regimen for at least 90 days before screening.
- Have a pain pattern consistent with diabetic peripheral neuropathy, such as a plausible bilateral stocking-glove distribution.