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Gene therapy shot may ease diabetic foot pain for a year

NCT ID NCT04873232

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

106 people

The number who actually took part.

Started

May 2021

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Completed study VMDN-003-2 and consent to enroll in study VMDN-003-2b Exclusion Criteria: * None

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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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