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Gene Therapy for Painful Diabetic Neuropathy

NCT01002235 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-10-06

Study results available
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Summary

The purpose of this open label, Phase I/II, dose-escalation, 3-cohort, multicenter, 12-month study, is to assess the safety and tolerability of injecting Engensis (VM202) in the leg muscle in patients with painful diabetic peripheral neuropathy (DPN). The study will also assess the potential of VM202 to reduce the pain associated with diabetic peripheral neuropathy.

Conditions

  • Painful Diabetic Peripheral Neuropathy

Interventions

BIOLOGICAL

VM202

Intramuscular injections in the calf on Day 0 and Day 14.

Sponsors & Collaborators

  • Helixmith Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • John Kessler, M.D. · Northwestern Memorial Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01002235 on ClinicalTrials.gov