Diabetic Neuropathy in Type 1 and 2 Diabetics

  • STATUS
    Recruiting
  • sponsor
    Forest
Updated on 25 March 2021

Summary

Diabetic Neuropathy in Type 1 and 2 Diabetics

Description

Northern California Research is conducting a study for diabetic peripheral neuropathy (DPN). DPN is a type of nerve damage that can occur if you have diabetes. This study is for men and women who are experiencing painful diabetic peripheral neuropathy in both lower extremities (legs). The specific events that result in painful diabetic neuropathy are not well understood, but high blood sugar, reduced blood flow in the limbs, and changes in the blood vessels are thought to result in damage to the nerves in the affected areas. Stimulating the growth of new blood vessels may stimulate growth or regeneration of nerves and may reduce pain.

Researchers have discovered that a protein called HGF (hepatocyte growth factor) that your body naturally produces in small amounts can cause the growth of new blood vessels and protect nerves. Unfortunately, your body only makes a small amount of this protein and not always in the areas where you need it. Researchers have found a way to increase the amount of HGF in your legs. They have isolated the genes responsible for directing the production of HGF and have designed a product that can be injected into your leg. The study medication is a plasmid (a small piece of DNA), which includes the HGF genes.

The purpose of this study is to evaluate the study medication in comparison to a placebo in order to determine if it relieves pain associated with painful diabetic neuropathy. We are looking for participants ages 18 to 75 who have painful DPN in their legs and/or feet. This is a double blinded study, which means neither you nor the study doctor will know what medication group you will be placed into. You will be randomly assigned by chance to receive either study medication or placebo (inactive medication); you will have 50% chance of receiving study medication. The study length is 12 months (1 year) and includes 11 office visits to our site. During 4 out of the 11 visits you will receive study medication. All trial-related visits, tests, and medications will be provided to you at no cost. In addition, reimbursement for trial-related time and travel may be provided.

Details
Clinical Study IdentifierTX152615
SponsorForest
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Type 1 or 2 diabetes and currently on medication for diabetes (oral, injectable and/or insulin)
-75 years old
Diagnosis of painful diabetic neuropathy in both lower extremities for at least 6 months

Exclusion Criteria

An active infection
Hepatitis A, B, C or HIV
Stroke or heart attack within the last 3 months
Major psychiatric disorder that required hospitalization within the last 6 months
BMI greater than 45
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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