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Completed Phase 3 Interventional Results available

A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy

ClinicalTrials.gov ID: NCT04873232

Public ClinicalTrials.gov record NCT04873232. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 4:56 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A 6-Month Extension Study Following Protocol VMDN-003-2 - An Adaptive, Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

To evaluate the durability of efficacy and long-term safety of intramuscular administration of Engensis or Placebo that was administered in the double-blind, randomized, VMDN-003-2 Placebo-controlled Phase 3 Study.

Study identification

NCT ID
NCT04873232
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Helixmith Co., Ltd.
Industry
Enrollment
106 participants

Conditions and interventions

Interventions

Biological · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 17, 2021 (Actual)
Primary completion
Sep 14, 2023 (Actual)
Completion
Jul 23, 2024 (Actual)
Last update posted
Oct 9, 2025

2021 – 2024

United States locations

U.S. sites
16
U.S. states
10
U.S. cities
16
Facility City State ZIP Site status
Arizona Research Center Phoenix Arizona 85053 —
Clinical Trials - Little Rock Little Rock Arkansas 72205 —
California Medical Clinic for Headache Los Angeles California 90048 —
Clinical Trials Research - Sacramento Sacramento California 95821 —
Innovative Research of West Florida, Inc. Clearwater Florida 33756 —
Gateway Clinical Trials, LLC O'Fallon Illinois 62269 —
Foot & Ankle Center of Illinois Springfield Illinois 62704 —
Clinical Research Professionals Chesterfield Missouri 63005 —
Richmond Behavioral Associates Staten Island New York 10314 —
Health Concepts Rapid City South Dakota 57702 —
Nerve and Muscle Center of Texas Houston Texas 77030 —
Futuro Clinical Trials McAllen Texas 78501 —
ClinPoint Trials LLC Waxahachie Texas 75165 —
Manassas Clinical Research Center Manassas Virginia 20110 —
Eastern Virginia Medical School Norfolk Virginia 23510 —
Dominion Medical Associates Richmond Virginia 23219 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04873232, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 9, 2025 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04873232 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →