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Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers

NCT02563522 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-10-09

Study results available
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Summary

This study will assess the safety and efficacy of using gene therapy via intramuscular injections of the calf for patients with chronic non-healing foot ulcers.

Conditions

  • Foot Ulcer, Diabetic

Interventions

GENETIC

Engensis (VM202)

gene therapy

DRUG

Placebo

Standard of care plus placebo

Sponsors & Collaborators

  • Helixmith Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Emerson C. Perin, MD · Texas Heart Institute

  • David G Armstrong,, DPM, MD, PhD · Keck School of Medicine of University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-06-27
Primary Completion
2019-09-24
Completion
2019-09-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT02563522 on ClinicalTrials.gov