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Working to stop painful diabetic peripheral neuropathy in its tracks.
The REGAiN-1A Study: a clinical study of an investigational drug designed to potentially relieve the pain caused by this condition.
What is diabetic peripheral neuropathy?

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.

About the REGAiN-1A Study

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.

White male patient with white female clinician
Who can participate in this study?

You may be eligible to participate in this clinical study if you are 18 years of age or older and:

  • Have been diagnosed with type 1 or 2 diabetes
  • Have an HbA1c equal to or less than 10.0%
  • Have been diagnosed with painful DPN in your feet and both lower legs for at least six months

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.

What can participants expect?

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:

  • Engensis Group: This group will receive injections of 32 mg of Engensis over the course of four visits. At each visit, study participants will receive a total of 16 injections into each calf with a very fine needle.
  • Placebo Control Group: Study participants in this group will receive a sterile saline solution without any active ingredients, rather than Engensis, using the identical injection technique. This group will receive the same number of injections as the Engensis Group.
Find a study center near you

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.

Frequently asked questions

Currently, there are no approved drugs known to stop or reverse the progression of diabetic peripheral neuropathy. Treatment goals are to reduce pain, improve physical function, and improve quality of life. There are four drugs approved by FDA for the treatment of the pain associated with this condition. Ask your doctor for more information.
During a clinical study, a medication is being evaluated to determine whether or not it may help you. If you participate, you may also have the following procedures performed to monitor your health: vital signs, blood work, physical exams, and other types of assessments that are necessary to gather the required information about the study medication. In some studies, you may not receive the study medication, but instead receive a placebo. All study volunteers are always closely monitored by clinic staff and the medical team to ensure their safety.

Placebo: A placebo looks like the study drug being tested, but it doesn’t have any active ingredients. In placebo-controlled research, one group is given the inactive treatment, while another group is given the active treatment. This is the best way to find out if the treatment being tested works better than receiving no treatment at all.
There will be between 152 and 250 patients taking part in this clinical study at approximately 15 study centers across the United States.
Participation in any clinical study is completely voluntary. Your decision to participate – or not participate – in this clinical study will have no effect on the medical care that you receive now or in the future. If you are eligible and choose to participate in the study, you may leave the clinical study at any time, and for any reason.
There are many reasons to participate in clinical research. For starters, it allows participants to play a more proactive role in their own health by receiving a new treatment for an ongoing disease or condition. Participants also play an important part in bringing much-needed drugs to market, benefiting thousands of people who also have the disease or condition. In many cases, this can be life-changing.
Every clinical trial must be reviewed, and is continually monitored, by a regulatory review committee to ensure that the risks are as low as possible.
Helixmith Co., Ltd. is responsible for conducting this clinical study.
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**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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