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Safety and Efficacy Study for the Treatment of Painful Diabetic Neuropathy

NCT01475786 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-10-06

Study results available
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Summary

The purpose of this study is to determine if Engensis (VM202) is safe and effective in treating painful diabetic neuropathy.

Conditions

  • Painful Diabetic Neuropathies

Interventions

BIOLOGICAL

Low Dose: 16 mg Engensis (VM202)

Subjects in the Low Dose Group (8mg VM202 / leg) will receive the following intramuscular injections in each calf: Day 0 - 32 injections / calf: • 16 injections of 0.5mL of VM202 / calf - (4 mg of VM202 / calf) Day 14 - 32 injections / calf: • 16 injections of 0.5mL of VM202 / calf - (4 mg of VM202 / calf)

BIOLOGICAL

High Dose: 32 mg Engensis (VM202)

Subjects in the High Dose Group (16 mg VM202 / leg) will receive the following intramuscular injections in each calf: Day 0 • 32 injections of 0.5mL of VM202 / calf (8 mg of VM202 / calf) Day 14 • 32 injections of 0.5mL of VM202 / calf (8 mg of VM202 / calf)

OTHER

Control- Placebo (normal saline)

subjects will receive thirty-two (32) 0.5 mL injections of normal saline on Day 0 and Day 14.

Sponsors & Collaborators

  • Helixmith Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jack Kessler, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-03-12
Completion
2014-06-30

Countries

  • United States
  • South Korea

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 NCT01475786 on ClinicalTrials.gov