Critical Limb IschemiaPhase 2NCT01064440
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia
A Phase 2 study testing Low Dose VM202 and High Dose VM202 in people with Critical Limb Ischemia, run by Helixmith Co., Ltd. at 16 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate whether intramuscular injections of VM202 into the calf is safe and effective in the treatment of critical limb ischemia. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- Low Dose VM202 and High Dose VM202
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 9 Jul 2010to 17 Nov 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, between 18 and 90 years of age;
- Diagnosis of critical limb ischemia (Rutherford Class 4 or 5), including:
- A resting ankle systolic pressure (in either the dorsalis pedis or posterior tibial arteries) of ≤ 70 mmHg in the affected limb; or
- A resting toe systolic pressure of ≤ 50 mmHg in the affected limb; or
- For patients in which measurement of ankle systolic pressure is not feasible (e.g. vessel calcification and non-compressibility); TcPO2 ≤ 30 mmHg;
- Poor or suboptimal candidate for bypass graft surgery or percutaneous angioplasty;
Show all 12Show fewer
- Pain at rest, and/or ischemic ulcers, and/or focal gangrene (< 3 cm2) for a minimum of 2 weeks,
- Significant stenosis (≥ 75%) of one or more of the following arteries: superficial femoral, popliteal, or two or more infra-popliteal arteries as verified by angiography within 12 months prior to enrollment;
- Be willing to maintain current drug therapy for peripheral arterial disease throughout the course of the study including an anti-platelet and statin treatment unless not tolerated;
- Clinically stable on optimized medical regimen for >30 days
- Be capable of understanding and complying with the protocol and signing the informed consent document prior to being subjected to any study related procedures;
- Women who are surgically sterile or at least 1 year postmenopausal or who have been practicing adequate contraception for at least 12 weeks prior to entering the study. If the subject is of child-bearing potential, she must have a negative urine pregnancy test result prior to study enrollment and must agree to repeat pregnancy screening tests during the study. If the subject or the subject's partner(s) is of child bearing potential, the subject and the subject's partner(s) must agree to use a "double barrier" method of birth control while participating in this study.
Who cannot join
- Subjects who have undergone a successful revascularization procedure or sympathectomy within 12 weeks prior to study entry. A clinically unsuccessful revascularization procedure is defined as one in which:
- the target vessel re-occludes (≥50%, as verified by a second angiogram. Duplex ultrasonography can be used to determine vessel patency if the patient cannot tolerate a second angiogram), or
- the target vessel remains patent, but there is no resolution of symptoms 6 weeks after the procedure (e.g. no evidence of ulcer healing, no improvement in pressures, no reduction in resting pain);
- Subjects that will require an amputation in the target leg within 4 weeks of randomization;
- Subjects with evidence of active infection (e.g., cellulitis, osteomyelitis) or deep ulceration exposing bone or tendon in the extremity planned for treatment;
- Heart Failure with a NYHA classification of III or IV;
Show all 25Show fewer
- Stroke (NIH scale >2) or myocardial infarction within last 3 months;
- Unstable angina
- Uncontrolled hypertension defined as sustained systolic blood pressure (SBP) > 200 mmHg or diastolic BP (DBP) > 110 mmHg at baseline/screening evaluation;
- Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that preclude standard ophthalmologic examination;
- Inflammatory disorder of the blood vessels (inflammatory angiopathy, such as Buerger's disease);
- Subjects with advanced liver disease including decompensated cirrhosis, jaundice, ascites or bleeding varices;
- Subjects currently receiving immunosuppressive medications chemotherapy, or radiation therapy;
- Positive HIV or HTLV at screening;
- Active Hepatitis B or C infection as determined by Hepatitis B surface antibody (HBsAb), Hepatitis B core antibody (IgG and IgM; HBcAb), Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV), at Screening;
- Specific laboratory values at Screening including: Hemoglobin < 8.0 g/dL, WBC < 3,000 cells per microliter, platelet count <75,000/mm3, AST and/or ALT > 3 times the upper limit of normal or any other clinically significant lab abnormality which in the opinion of the investigator should be exclusionary;
- Patients 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); patients with family history of colon cancer in any first degree relative are excluded unless they have undergone a colonoscopy in the last 12 months with negative findings;
- Elevated PSA unless prostate cancer has been excluded;
- Subjects with any co- morbid conditions likely to interfere with assessment of safety or efficacy or with an estimated life expectancy of less than 6 months
- Subjects requiring > 81 mg daily of acetylsalicylic acid; If > 81 mg are taken at screening, subjects may be enrolled if willing/able to switch to another medication;
- Subjects requiring regular COX-2 inhibitor drug(s) or high dose steroids (excepting inhaled steroids);
- Major psychiatric disorder in past 6 months;
- History of drug or alcohol abuse / dependence in the past 2 years;
- Use of an investigational drug or treatment in past 12 months; concurrent participation in investigational protocol or unapproved therapeutics and
- Unable or unwilling to give informed consent.
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States13 sites
Cardiology PC
Birmingham, Alabama, 35211
Boston University School of Medicine
Boston, Massachusetts, 02118
UNC School of Medicine
Chapel Hill, North Carolina, 27599
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Texas Heart Institute
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
St. Vincent Medical Group
Indianapolis, Indiana, 46290
University of Minnesota
Minneapolis, Minnesota, 55454
University of Oklahoma HSC
Oklahoma City, Oklahoma, 73104
Vascular and Interventional Specialist of Orange County
Orange, California, 92868
University of Utah
Salt Lake City, Utah, 84132
Saint Louis University
St Louis, Missouri, 63110
Jobst Vascular
Toledo, Ohio, 43506
South Korea3 sites
Seoul National University
Seoul, Jongno-gu, 110-744
Yonsei University Health System. Severance Cardiovascular Hospital
Seoul, Seodaemun-gu, 120-752
Ewha Womans University Medical Center
Seoul, YangCheon-ku, 158-710
About this study
Official title: A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of VM202 (Engensis) in Subject With Critical Limb Ischemia
The purpose of this study is to evaluate whether intramuscular injections of VM202 into the calf is safe and effective in the treatment of critical limb ischemia.
Read the detailed description
In the absence of revascularization options, most patients with CLI require amputation within 6 months. Patients requiring major amputation face a diminished quality of life, an unfavorable natural history and need extensive resources for their post-amputation rehabilitation and course. The 1-year amputation-free survival rate for patients diagnosed with CLI is 45%; the mortality rate is approximately 25% and may be as high as 45% in those who have undergone amputation. Management of this end-stage disease process consumes a significant amount of healthcare resources. Clearly, new therapeutic approaches are required.
Hepatocyte growth factor (HGF) has been shown to be a potent angiogenic growth factor stimulating the growth of endothelial cells and migration of vascular smooth muscle cells. Because of its pluripotent capabilities, increasing the availability of HGF in ischemic tissues to achieve therapeutic angiogenesis has been a growing area of research.
This study will use VM202, which is a DNA plasmid that contains novel genomic cDNA hybrid human HGF coding sequence (HGF-X7) expressing two isoforms of HGF, HGF 728 and HGF 723. As there are currently no approved drugs that can reverse CLI and as most patients have exhausted surgical and endovascular intervention options, inducing angiogenesis in the affected limb with VM202 may result in an increase in tissue perfusion, which, in turn improve wound healing, reduce pain and improve limb salvage rates.
- Conditions
- Critical Limb Ischemia
- Being tested
- Low Dose VM202, High Dose VM202, Placebo
- Keywords
- Painful legs, Ischemic legs, Treatment for Claudication, Gene therapy
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose VM202Biological
Also called DNA Plasmid, HGF-X7
Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202)
High Dose VM202Biological
Also called DNA Plasmid, HGF-X7
Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day 14: 4mg of VM202 (16 injections of 0.5ml of VM202) Day 28: 4mg of VM202 (16 injections of 0.5ml of VM202) Day 42: 4mg of VM202 (16 injections of 0.5ml of VM202)
PlaceboOther
Also called Normal Saline
Day 0: 16 injections of 0.5ml of normal saline Day 14: 16 injections of 0.5ml of normal saline Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Low Dose VM202 | Experimental | Patients in this group received 8mg total of VM202. Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202) Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline Receives: Biological: Low Dose VM202; Other: Placebo |
| High Dose VM202 | Experimental | Patients in this treatment group received a total of 16mg VM202. Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202) Day 28: 4mg of VM202 (16 injections of 0.5ml of VM202) Day42: 4mg of VM202 (16 injections of 0.5ml of VM202) Receives: Biological: High Dose VM202 |
| Placebo | Sham comparator | Patients in this group received a total of 8ml normal saline. Day 0: 16 injections of 0.5ml of normal saline Day 14: 16 injections of 0.5ml of normal saline Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
The number of participants with treatment-emergent adverse events (TEAEs), defined as adverse events occurring after the first injection of Engensis (VM202), was assessed in moderate or high-risk Critical Limb Ischemia subjects.
Measured: Baseline - Days 0, 14, 28, 42, 49, 90, 180, 270 and 365
Change From Baseline in Visual Analog Scale (VAS) for Pain
The Visual Analog Scale (VAS) for Pain scoring instrument is a 10 cm line, oriented horizontally, with the left end score of "0" indicating "no pain", and the right end score of "10" representing "pain as bad as it can be"
Measured: Days 0, 90, 180, 270, and 365
Secondary outcomes (10)
Change From Baseline in Tissue Oxygenation (TcPO2) for the Dorsal Surface of the Foot Following Engensis (VM202) or Placebo
Tissue Oxygenation (TcPO2) measurement is reported for the dorsum of the foot. The change in baseline for the TcPO2 measured in the dorsal surface of the foot results are reported for each of the 3 study groups: 8 mg, or 16 mg for the Engensis (VM202) group, or the Placebo group. Because of the indication being peripheral vascular disease, the dorsal surface of the foot was decided by the sponsor to be a good representative of the lower extremity for any of the other measured sites.
Measured: Day 0 to Days 180, 270, and 365
Change From Baseline in Hemodynamic Assessment for Ankle Brachial-Index (mmHg) for the Index Leg
Change in the Resting Ankle-Brachial Index (ABI) from Baseline (Day 0) for the Index Leg to Days 180, 270, and 365.
Note that by default, Day 0 has no change from baseline. Days 28 and 90 time point data was not included,as they were not relevant to assess efficacy, because of the delayed effect of Engensis, the investigational product.
Measured: Days 0, 28, 90, 180, 270, and 365
Change From Baseline in Perfusion of the Occluded Target Artery by Magnetic Resonance Angiogram (MRA)
The quantitative blood flow of the occluded target artery and the volumetric analysis of the newly developed artery by Magnetic Resonance Angiogram (MRA) were recorded.
Note that "no change from baseline table of data" is not presented because there was only one subject with both a Baseline and Post Treatment value for Magnetic Resonance Angiogram (MRA) measurement.
Measured: Day 0 to Days 180 and 270
Subjects With 100% Wound Healing
The length and width (in cm) was based on photographs and measurements of ulcers. If a ulcer was determined to be 100% healed, the area of the ulcer was set to 0
Measured: Days 0, 14, 28, 42, 49, 90, 180, 270, and 365
Change From Baseline in the Vascular Quality of Life Total Score
The Vascular Quality of Life Total Score (VascuQol) questionnaire has 25 questions that reviewed five domains: activity level (8 items), symptoms (4 items), pain (4 items), emotional (7 items), and social (2 items). The total score is the total of the non-missing scored divided by the number of responded questions.
The Vascular Quality of Life Total Score (VascuQol) scale is a 7-point scale with "1" as the worst change from baseline score, and "7" is the least change from baseline score.
Measured: Days 0, 90, 270, and 365
Number of Subjects With Major, Lower Leg, Amputations During the Trial
The number and percentage of subjects with major amputations during the trial
Measured: Day 0 through Day 365
The Number of Deaths During the Trial
The number and percentage of subjects who died during the trial
Measured: Day 0 to Day 365
Change From Baseline in Visual Analog Scale (VAS) for Pain at 9 Months- by Sex
The VAS scoring instrument is a 10 cm line, oriented horizontally, with the left end indicating "no pain" (score = 0 mm, better outcome) and the right end representing "pain as bad as it can be (score = 100 mm, worse outcome).
Measured: Days 0 (baseline), 9 months (Day 270)
Change From Baseline in Visual Analog Scale (VAS) for Pain at 9 Months- by Renal Dysfunction Status
The VAS scoring instrument is a 10 cm line, oriented horizontally, with the left end indicating "no pain" (score = 0 mm, better outcome) and the right end representing "pain as bad as it can be (score = 100 mm, worse outcome).
Measured: Days 0 (baseline), 9 months (Day 270)
Change From Baseline in Visual Analog Scale (VAS) for Pain at 9 Months- by Diabetes Status
The VAS scoring instrument is a 10 cm line, oriented horizontally, with the left end indicating "no pain" (score = 0 mm, better outcome) and the right end representing "pain as bad as it can be (score = 100 mm, worse outcome).
Measured: Days 0 (baseline), 9 months (Day 270)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study start9 Jul 2010
- Primary completion5 Aug 2013
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helixmith Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emerson Perin, MD, Principal investigator, Texas Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064440
- Sponsor's protocol ID
- VMCLI-II-09-002/E
- Status last verified
- Aug 2025
- First submitted
- 4 Feb 2010
- Last updated
- 6 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kibbe MR, Hirsch AT, Mendelsohn FO, Davies MG, Pham H, Saucedo J, Marston W, Pyun WB, Min SK, Peterson BG, Comerota A, Choi D, Ballard J, Bartow RA, Losordo DW, Sherman W, Driver V, Perin EC. Safety and efficacy of plasmid DNA expressing two isoforms of hepatocyte growth factor in patients with critical limb ischemia. Gene Ther. 2016 Mar;23(3):306-12. doi: 10.1038/gt.2015.110. Epub 2015 Dec 8.
PubMed 26649448
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of VM202 (Engensis) in Subject With Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT01064440
- Acronym / sponsor ID
- VMCLI-II-09-002/E
- Conditions
- Critical Limb Ischemia
- Keywords
- Painful legs, Ischemic legs, Treatment for Claudication, Gene therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Helixmith Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2010 (actual)
- Primary completion
- 5 Aug 2013 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 8 Feb 2010 (estimated)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether intramuscular injections of VM202 into the calf is safe and effective in the treatment of critical limb ischemia.
Detailed description
In the absence of revascularization options, most patients with CLI require amputation within 6 months. Patients requiring major amputation face a diminished quality of life, an unfavorable natural history and need extensive resources for their post-amputation rehabilitation and course. The 1-year amputation-free survival rate for patients diagnosed with CLI is 45%; the mortality rate is approximately 25% and may be as high as 45% in those who have undergone amputation. Management of this end-stage disease process consumes a significant amount of healthcare resources. Clearly, new therapeutic approaches are required.
Hepatocyte growth factor (HGF) has been shown to be a potent angiogenic growth factor stimulating the growth of endothelial cells and migration of vascular smooth muscle cells. Because of its pluripotent capabilities, increasing the availability of HGF in ischemic tissues to achieve therapeutic angiogenesis has been a growing area of research.
This study will use VM202, which is a DNA plasmid that contains novel genomic cDNA hybrid human HGF coding sequence (HGF-X7) expressing two isoforms of HGF, HGF 728 and HGF 723. As there are currently no approved drugs that can reverse CLI and as most patients have exhausted surgical and endovascular intervention options, inducing angiogenesis in the affected limb with VM202 may result in an increase in tissue perfusion, which, in turn improve wound healing, reduce pain and improve limb salvage rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose VM202 | Experimental | Biological: Low Dose VM202, Other: PlaceboPatients in this group received 8mg total of VM202. Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202) Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline |
| High Dose VM202 | Experimental | Biological: High Dose VM202Patients in this treatment group received a total of 16mg VM202. Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202) Day 28: 4mg of VM202 (16 injections of 0.5ml of VM202) Day42: 4mg of VM202 (16 injections of 0.5ml of VM202) |
| Placebo | Sham comparator | Other: PlaceboPatients in this group received a total of 8ml normal saline. Day 0: 16 injections of 0.5ml of normal saline Day 14: 16 injections of 0.5ml of normal saline Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female, between 18 and 90 years of age;
- Diagnosis of critical limb ischemia (Rutherford Class 4 or 5), including:
- Poor or suboptimal candidate for bypass graft surgery or percutaneous angioplasty;
- Pain at rest, and/or ischemic ulcers, and/or focal gangrene (< 3 cm2) for a minimum of 2 weeks,
- Significant stenosis (≥ 75%) of one or more of the following arteries: superficial femoral, popliteal, or two or more infra-popliteal arteries as verified by angiography within 12 months prior to enrollment;
Key exclusion criteria (25 listed)
- Subjects who have undergone a successful revascularization procedure or sympathectomy within 12 weeks prior to study entry. A clinically unsuccessful revascularization procedure is defined as one in which:
- Subjects that will require an amputation in the target leg within 4 weeks of randomization;
- Subjects with evidence of active infection (e.g., cellulitis, osteomyelitis) or deep ulceration exposing bone or tendon in the extremity planned for treatment;
- Heart Failure with a NYHA classification of III or IV;
- Stroke (NIH scale >2) or myocardial infarction within last 3 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dose VM202Also: DNA Plasmid, HGF-X7Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202) | Biological | Low Dose VM202 |
| High Dose VM202Also: DNA Plasmid, HGF-X7Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day 14: 4mg of VM202 (16 injections of 0.5ml of VM202) Day 28: 4mg of VM202 (16 injections of 0.5ml of VM202) Day 42: 4mg of VM202 (16 injections of 0.5ml of VM202) | Biological | High Dose VM202 |
| PlaceboAlso: Normal SalineDay 0: 16 injections of 0.5ml of normal saline Day 14: 16 injections of 0.5ml of normal saline Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline | Other | Low Dose VM202, Placebo |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Time frame: Baseline - Days 0, 14, 28, 42, 49, 90, 180, 270 and 365
The number of participants with treatment-emergent adverse events (TEAEs), defined as adverse events occurring after the first injection of Engensis (VM202), was assessed in moderate or high-risk Critical Limb Ischemia subjects.
Change From Baseline in Visual Analog Scale (VAS) for Pain
Time frame: Days 0, 90, 180, 270, and 365
The Visual Analog Scale (VAS) for Pain scoring instrument is a 10 cm line, oriented horizontally, with the left end score of "0" indicating "no pain", and the right end score of "10" representing "pain as bad as it can be"
10 secondary outcomes
Change From Baseline in Tissue Oxygenation (TcPO2) for the Dorsal Surface of the Foot Following Engensis (VM202) or Placebo
Time frame: Day 0 to Days 180, 270, and 365
Change From Baseline in Hemodynamic Assessment for Ankle Brachial-Index (mmHg) for the Index Leg
Time frame: Days 0, 28, 90, 180, 270, and 365
Change From Baseline in Perfusion of the Occluded Target Artery by Magnetic Resonance Angiogram (MRA)
Time frame: Day 0 to Days 180 and 270
Subjects With 100% Wound Healing
Time frame: Days 0, 14, 28, 42, 49, 90, 180, 270, and 365
Change From Baseline in the Vascular Quality of Life Total Score
Time frame: Days 0, 90, 270, and 365
Number of Subjects With Major, Lower Leg, Amputations During the Trial
Time frame: Day 0 through Day 365
The Number of Deaths During the Trial
Time frame: Day 0 to Day 365
Change From Baseline in Visual Analog Scale (VAS) for Pain at 9 Months- by Sex
Time frame: Days 0 (baseline), 9 months (Day 270)
Change From Baseline in Visual Analog Scale (VAS) for Pain at 9 Months- by Renal Dysfunction Status
Time frame: Days 0 (baseline), 9 months (Day 270)
Change From Baseline in Visual Analog Scale (VAS) for Pain at 9 Months- by Diabetes Status
Time frame: Days 0 (baseline), 9 months (Day 270)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26649448Kibbe MR, Hirsch AT, Mendelsohn FO, Davies MG, Pham H, Saucedo J, Marston W, Pyun WB, Min SK, Peterson BG, Comerota A, Choi D, Ballard J, Bartow RA, Losordo DW, Sherman W, Driver V, Perin EC. Safety and efficacy of plasmid DNA expressing two isoforms of hepatocyte growth factor in patients with critical limb ischemia. Gene Ther. 2016 Mar;23(3):306-12. doi: 10.1038/gt.2015.110. Epub 2015 Dec 8.
- Plasmid DNA of HGF in patients with critical limb ischemiaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emerson Perin, MD principal investigator
Texas Heart Institute
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low Dose VM202 and High Dose VM202 in people with Critical Limb Ischemia, run by Helixmith Co., Ltd. at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia. (time frame: Baseline - Days 0, 14, 28, 42, 49, 90, 180, 270 and 365). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01064440, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.