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

NCT02563522 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: VMNHU-003
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 22

Brief 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

Keywords

non healing ulcers; VM202; Diabetic ulcers; foot ulcers; Engensis

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects With a Target Wound Closure by the 4-month Follow-up Visit

  Determine the proportion of subjects with a target Wound Closure from baseline to month 4 visit

  Days 0 to Month 4

Study Arms (2)

Active

ACTIVE COMPARATOR

Engensis (VM202) + standard of care

Genetic: Engensis (VM202)

Control

PLACEBO COMPARATOR

Placebo (VM202 Vehicle) + standard of care

Drug: Placebo

Interventions

Engensis (VM202) GENETIC

gene therapy

Active

Placebo DRUG

Standard of care plus placebo

Also known as: VM202 vehicle

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, between 18 and 80 years of age
• Documented history of symptomatic PAD, with one or more of the following criteria satisfied:
• ABI \>0.40 and ≤0.90 or \>1.4 (i.e., mild to severe PAD without critical limb ischemia) in target limb
• TBI ≤0.7 in the target limb
• Toe pressure of \<55 mmHg in the target limb
• A history of lower extremity PAD with previous related intervention in a leg
• Documented history of Type I or II diabetes with current treatment control (HbA1c of ≤12.0% at Screening) and currently on oral medication, injectable medication, and/or insulin
• No significant changes were anticipated in diabetes medication regimen
• At Screening, the subject had one ulcer on the target foot that fulfilled all of the following criteria:
• Present for ≥2 weeks and ≤1 year
• Full-thickness and not involving bone, tendon, or capsule (probing to tendon or capsule)
• No sign of infection or osteomyelitis

You may not qualify if:

• Capable of understanding and complying with the protocol and signed the informed consent document prior to being subjected to any study related procedures
• If female of childbearing potential, negative urine pregnancy test at Screening and used an acceptable method of birth control during the study
• Required revascularization in the target leg within 3 months of randomization
• In the Investigator's assessment, required an amputation in the target leg within 3 months of randomization
• Subjects with target foot ulcer with an etiology of vasculitis, pyoderma gangrenosum, necrobiosis lipoidica, hydrostatic pressure/venous insufficiency, any neoplasms (basalioma, Kaposi's sarcoma, squamous cell carcinoma, etc.), or due to a burn
• The study ulcer increased or decreased by 50% or more at Baseline from Screening (as assessed by comparison of post-debridement photos taken at Screening and Day 0)
• Evidence of active infection (e.g., cellulitis, osteomyelitis) or deep ulceration exposing bone or tendon in the foot planned for treatment
• Any gangrene
• Current fracture in the target foot
• Target ulcer located on an active (hot) Charcot foot
• Heart Failure with a New York Heart Association (NYHA) classification of III or IV
• Body mass index (BMI) \>45 kg/m2 at Screening
• Stroke or myocardial infarction within the last 3 months
• Unstable angina
• Uncontrolled hypertension defined as sustained systolic blood pressure (SBP) \>200 mmHg or diastolic blood pressure (DBP) \>110 mmHg at Baseline/Screening evaluation

Sponsors & Collaborators

• Helixmith Co., Ltd.: lead

Study Sites (22)

Central Research Associates, Inc.

Birmingham, Alabama, 35205, United States

Location

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

NEA Baptist

Jonesboro, Arkansas, 72401, United States

Location

Sacramento Foot and Ankle

Carmichael, California, 95608, United States

Location

Bay Area Foot and Ankle

Castro Valley, California, 94546, United States

Location

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

Location

USC Keck School of Medicine

Los Angeles, California, 90033, United States

Location

Foot and Ankle Clinic

Los Angeles, California, 90057, United States

Location

Center for Clinical Research Inc.

San Francisco, California, 94115, United States

Location

Olive View-UCLA Education & Research Institute

Sylmar, California, 91342, United States

Location

LCC Medical Research Institute

Miami, Florida, 33126, United States

Location

Miami Dade Medical Research Institute, LLC

Miami, Florida, 33176, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

UMASS Memorial Med Center

Worcester, Massachusetts, 01655, United States

Location

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Advanced Foot & Ankle Center

Las Vegas, Nevada, 89119, United States

Location

Oregon Foot and Ankle Center

Eugene, Oregon, 97401, United States

Location

MedResearch, Inc

El Paso, Texas, 79932, United States

Location

Acclaim Bone & Joint Institute

Fort Worth, Texas, 76107, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

Futuro Clinical Trials

McAllen, Texas, 78501, United States

Location

Related Publications (1)

• Perin E, Loveland L, Caporusso J, Dove C, Motley T, Sigal F, Vartivarian M, Oliva F, Armstrong DG; VMNHU-003 study group. Gene therapy for diabetic foot ulcers: Interim analysis of a randomised, placebo-controlled phase 3 study of VM202 (ENGENSIS), a plasmid DNA expressing two isoforms of human hepatocyte growth factor. Int Wound J. 2023 Nov;20(9):3531-3539. doi: 10.1111/iwj.14226. Epub 2023 May 25.

  PMID: 37230802 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Foot Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases

Results Point of Contact

• Title: Jinsub Lee, PhD.
• Organization: Helixmith Co., Ltd.

jinsub.lee@helixmith.com

+82-10-8256-0439

Study Officials

• Emerson C. Perin, MD

  Texas Heart Institute

  PRINCIPAL INVESTIGATOR

• David G Armstrong,, DPM, MD, PhD

  Keck School of Medicine of University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Active: Engensis (VM202) + standard of care - 200 subjects Control: Placebo (VM202 vehicle) + standard of care - 100 subjects

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: September 30, 2015
• Study Start: June 27, 2017
• Primary Completion: September 24, 2019
• Study Completion: September 24, 2019
• Last Updated: October 9, 2025
• Results First Posted: February 22, 2023

Record last verified: 2025-08

Locations

US (22)