Diabetic peripheral neuropathy (DPN) is a condition that causes nerve damage in the legs and feet. It is one of the most common complications associated with diabetes, affecting nearly 60% of diabetics. DPN causes numbness and/or burning or shooting pain and is often worse at night. If left untreated, the damage caused by this condition can lead to serious complications.
Diabetic peripheral neuropathy (DPN) is a serious complication of diabetes that results in nerve damage. This causes burning, tingling or shooting pain in your legs and feet. The exact cause of DPN is not well understood, but the damage to nerves may be linked to high blood sugar, reduced blood flow, and changes in your blood vessels.
Your body produces a small amount of protein called hepatocyte growth factor (HGF) which researchers have found can protect, repair and promote the growth of nerves and blood vessels. The REGAiN-1A Study is evaluating an investigational drug that may increase the amount of HGF in your legs and potentially reduce the pain caused by DPN.
You may be eligible to participate in this clinical study if you are 18 years of age or older and:
Only a member of our study team can determine your final eligibility. To learn more, please find your local study center from the list below and schedule a Screening visit.
The REGAiN-1A Study is a clinical study designed to evaluate the safety and effectiveness of an investigational drug (Engensis) in patients with painful DPN. The goal is to see what effect Engensis has on reducing pain in the feet and lower legs. It will be compared to a placebo, which is an inactive substance that has no effect on the body.
Participation in this clinical study will last approximately 6 months and requires 8 visits to a clinic. This study is “double-blinded” meaning that the study doctor and the participant will not know which treatment is being given. All study participants will be randomly assigned (50/50 chance) to one of two treatment groups:
To see if the REGAiN-1A Study is right for you, please find your local study center from the list below. Then contact a member of our study team to schedule your screening visit.
For additional study information, please visit https://www.clinicaltrials.gov/ct2/show/NCT04469270?term=NCT04469270&draw=2&rank=1.
**THE IMAGES DEPICTED CONTAIN MODELS AND ARE USED FOR ILLUSTRATIVE PURPOSES ONLY.**
Disclaimer - Engensis has not been demonstrated to be safe or effective for any indication and is not available for sale in the United States or any other country. CAUTION: New Drug--Limited by Federal (or United States) law to investigational use.
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