Gene therapy shot aims to ease diabetic foot pain

NCT ID NCT04469270

First seen Jun 27, 2026 ยท Last updated Jun 27, 2026

Summary

This Phase 3 study tested whether injections of engensis, a gene therapy, can reduce pain in the feet and legs caused by diabetic nerve damage. 162 adults with type 1 or 2 diabetes received either engensis or a placebo. The main goal was to see if pain scores improved over 180 days.

What this could mean

Our plain-language read of the trial. This is informational only โ€” not medical advice or a prediction.

Active substance
Engensis (a gene therapy given as injections into the muscle)
What this could lead to
If it works, this could provide a new option to reduce chronic nerve pain in people with diabetes.
What could go wrong
This is a Phase 3 trial, but results are not yet known. The treatment may not reduce pain better than a placebo, and injections carry risks like soreness or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for DIABETIC NEUROPATHY, PAINFUL are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Arizona Research Center

    Phoenix, Arizona, 85053, United States

  • California Medical Clinic for Headache

    Los Angeles, California, 90048, United States

  • ClinPoint Trials LLC

    Waxahachie, Texas, 75165, United States

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005, United States

  • Clinical Trials - Little Rock

    Little Rock, Arkansas, 72205, United States

  • Clinical Trials Research - Sacramento

    Sacramento, California, 95821, United States

  • Dominion Medical Associates

    Richmond, Virginia, 23219, United States

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23510, United States

  • Foot & Ankle Center of Illinois

    Springfield, Illinois, 62704, United States

  • Futuro Clinical Trials, LLC

    McAllen, Texas, 78501, United States

  • Gateway Clinical Trials, LLC

    O'Fallon, Illinois, 62269, United States

  • Health Concepts

    Rapid City, South Dakota, 57702, United States

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida, 33756, United States

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110, United States

  • Nerve and Muscle Center of Texas

    Houston, Texas, 77030, United States

  • Richmond Behavioral Associates

    Staten Island, New York, 10314, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.