Gene therapy shot may ease diabetic foot pain for a year

NCT ID NCT04873232

Completed Symptom relief Sponsor: Helixmith Co., Ltd. Source: ClinicalTrials.gov ↗

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

Summary

This study tested whether a gene therapy called engensis can safely reduce pain from diabetic nerve damage over 6 to 12 months. About 100 people who completed an earlier trial received either engensis or placebo injections into their leg muscles. Researchers measured changes in daily pain scores to see if the treatment provides lasting relief.

What this could mean

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

Active substance: Engensis (a gene therapy given as injections into the leg muscles)
What this could lead to: If it works, this could provide lasting pain relief for people with diabetic nerve pain in the feet and legs.
What could go wrong: This is an extension study building on earlier results, so the main findings are still being analyzed. Pain relief may not be durable or may not differ from placebo.

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

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Conditions

The condition(s) this trial relates to.

diabetic neuropathy

As listed by the trial registrant

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

DIABETIC PERIPHERAL NEUROPATHY

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

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

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