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Study identifier: NCT04055090 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Completed

Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy

Condition: Painful Diabetic Neuropathy · Diabetic Neuropathy, Painful  ·  Sponsor: Helixmith Co., Ltd.

PhasePhase 3
Planned participants101
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where14 locations

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

The purpose of this study is to explore the overall safety profile and durability of efficacy of Engensis (VM202) in painful diabetic peripheral neuropathy. All subjects still in follow-up for the VMDN-003 study or who have completed the Day 270 visit within the prior 90 days will be approached to enroll in the long-term safety extension study.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: 1. Were randomized and dosed in the VMDN-003 study 2. Received all intramuscular injections of study drug on Days 0, 14, 90, and 104 in the VMDN-003 study 3. Were in follow-up for the VMDN-003 study or had completed Day 270 within the last 90 days prior to signing consent Exclusion Criteria: 1. Were using an investigational drug or treatment 2. Were unable or unwilling to give informed consent

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (14)

Arizona Research CenterPhoenix, Arizona, United States
Clinical Trials, Inc.Little Rock, Arkansas, United States
Northern California ResearchSacramento, California, United States
Center for Clinical ResearchSan Francisco, California, United States
Neurological Research InstituteSanta Monica, California, United States
Diablo Clinical Research, Inc.Walnut Creek, California, United States
Innovative Research of West FloridaClearwater, Florida, United States
University of Florida McKnight Brain InstituteGainesville, Florida, United States
Clinical Research of West FloridaTampa, Florida, United States
The Brigham and Women's HospitalBoston, Massachusetts, United States
Raleigh Neurology Associates, P.A.Raleigh, North Carolina, United States
Nerve and Muscle Center of TexasHouston, Texas, United States

+ 2 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

PhoenixLittle RockSacramentoSan Francisco

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