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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02563522
Other study ID # VMNHU-003
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date June 27, 2017
Est. completion date September 24, 2019

Study information

Verified date January 2023
Source Helixmith Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

A phase III, randomized, double-blind, placebo-controlled, multicenter, 7-month study designed to assess the safety and efficacy of intramuscular (IM) injections in the calf of Engensis (VM202) in patients with chronic nonhealing foot ulcers. Three hundred patients will be randomized in a 2:1 ratio of VM202 or placebo injections: - Active -Engensis (VM202) + standard of care - 200 patients - Control - Placebo (VM202 Vehicle) + standard of care - 100 patients


Recruitment information / eligibility

Status Terminated
Enrollment 44
Est. completion date September 24, 2019
Est. primary completion date September 24, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Male or female, between 18 and 80 years of age 2. Documented history of symptomatic PAD, with one or more of the following criteria satisfied: 1. ABI >0.40 and =0.90 or >1.4 (i.e., mild to severe PAD without critical limb ischemia) in target limb 2. TBI =0.7 in the target limb 3. Toe pressure of <55 mmHg in the target limb 4. A history of lower extremity PAD with previous related intervention in a leg 3. 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 4. No significant changes were anticipated in diabetes medication regimen 5. At Screening, the subject had one ulcer on the target foot that fulfilled all of the following criteria: 1. Present for =2 weeks and =1 year 2. Full-thickness and not involving bone, tendon, or capsule (probing to tendon or capsule) 3. No sign of infection or osteomyelitis 4. Ulcer must have been 0.5 cm2 to 15 cm2 as measured at the Screening visit prior to debridement If more than one ulcer was present on the foot, the largest ulcer that fulfilled the inclusion and exclusion criteria was considered the target (index) ulcer for the study. Subjects underwent protocol-defined standardized wound care during Screening (for two weeks or longer). Subjects were considered screen failures and did not receive study injections on Day 0 (Baseline) if the target ulcer did not meet all entry criteria (see above) as well as being confirmed as nonhealing. 6. Capable of understanding and complying with the protocol and signed the informed consent document prior to being subjected to any study related procedures 7. If female of childbearing potential, negative urine pregnancy test at Screening and used an acceptable method of birth control during the study Exclusion Criteria: 1. Required revascularization in the target leg within 3 months of randomization 2. In the Investigator's assessment, required an amputation in the target leg within 3 months of randomization 3. 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 4. 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) 5. Evidence of active infection (e.g., cellulitis, osteomyelitis) or deep ulceration exposing bone or tendon in the foot planned for treatment 6. Any gangrene 7. Current fracture in the target foot 8. Target ulcer located on an active (hot) Charcot foot 9. Heart Failure with a New York Heart Association (NYHA) classification of III or IV 10. Body mass index (BMI) >45 kg/m2 at Screening 11. Stroke or myocardial infarction within the last 3 months 12. Unstable angina 13. Uncontrolled hypertension defined as sustained systolic blood pressure (SBP) >200 mmHg or diastolic blood pressure (DBP) >110 mmHg at Baseline/Screening evaluation 14. Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that precluded standard ophthalmologic examination 15. Inflammatory disorder of the blood vessels (inflammatory angiopathy, such as Buerger's disease) 16. Subjects with advanced liver disease including decompensated cirrhosis, jaundice, ascites, or bleeding varices 17. Subjects currently receiving immunosuppressive medications chemotherapy, or radiation therapy 18. Positive human immunodeficiency virus (HIV) or human T-cell lymphotropic virus (HTLV) at Screening 19. Active hepatitis B or C infection as determined by hepatitis B surface antibody (HBsAb), hepatitis B core antibody (immunoglobulin G [IgG] and immunoglobulin M [IgM]; HBcAb), hepatitis B surface antigen (HBsAg), and hepatitis C antibodies (Anti-HCV) at Screening 20. Clinically significant specific laboratory values at Screening (e.g., hemoglobin <8.0 g/dL, white blood cell [WBC] <3,000/µL, platelet count <75,000/mm3, aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] >3 times the upper limit of normal, or any other clinically significant lab abnormality which in the opinion of the Investigator was exclusionary) 21. Glomerular filtration rate (GFR) <30 mL/min/1.73 m2 22. Subjects with a recent history (<5 years) of or new Screening finding of malignant neoplasm except basal cell carcinoma or squamous cell carcinoma of the skin (if excised and no evidence of recurrence for at least 1 year); subjects with medical history and/or family history of colon cancer in any first degree relative were excluded unless they had undergone a colonoscopy in the last 12 months with negative findings 23. Subjects with any comorbid conditions likely to have interfered with assessment of safety or efficacy or with an estimated life expectancy of less than 1 year 24. Subjects who required >81 mg daily of acetylsalicylic acid. If >81 mg was taken at Screening, subjects could be enrolled if they were willing/able to switch to another medication for the duration of the study 25. Subjects who required regular (daily) COX-2 inhibitor drug(s) or steroids (except inhaled steroids or ocular steroids); subjects could be enrolled if they were willing/able to undergo medication washout prior to the first dosing and refrained from taking these drugs during the study 26. Major psychiatric disorder in the past 6 months 27. History of drug or alcohol abuse/dependence in the past 2 years 28. Used an investigational drug in the past 3 months; used an investigational biologic in the past 12 months; concurrent participation in an investigational protocol or using unapproved therapeutics 29. Was unable or unwilling to give informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
Engensis (VM202)
gene therapy
Drug:
Placebo
Standard of care plus placebo

Locations

Country Name City State
United States Central Research Associates, Inc. Birmingham Alabama
United States Sacramento Foot and Ankle Carmichael California
United States Bay Area Foot and Ankle Castro Valley California
United States Northwestern University Chicago Illinois
United States MedResearch, Inc El Paso Texas
United States Oregon Foot and Ankle Center Eugene Oregon
United States Acclaim Bone & Joint Institute Fort Worth Texas
United States Texas Heart Institute Houston Texas
United States NEA Baptist Jonesboro Arkansas
United States Advanced Foot & Ankle Center Las Vegas Nevada
United States VA Long Beach Healthcare System Long Beach California
United States Foot and Ankle Clinic Los Angeles California
United States USC Keck School of Medicine Los Angeles California
United States Futuro Clinical Trials McAllen Texas
United States LCC Medical Research Institute Miami Florida
United States Miami Dade Medical Research Institute, LLC Miami Florida
United States Arizona Research Center Phoenix Arizona
United States Saint Louis University Saint Louis Missouri
United States Center for Clinical Research Inc. San Francisco California
United States Olive View-UCLA Education & Research Institute Sylmar California
United States University of Arizona Tucson Arizona
United States UMASS Memorial Med Center Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Helixmith Co., Ltd.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Armstrong DG, Perin E, Loveland L, Caporusso J, the VMNHU-003 study group. Gene therapy for diabetic foot ulcers: Interim analysis of a randomized, placebo-controlled phase 3 study of VM202 (ENGENSIS), a plasmid DNA expressing two isoforms of human hepatocyte growth factor (HGF). Diabetic Foot Ulcer Conference 2021 - Poster

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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