Gene therapy shots aim to save legs from amputation
NCT ID NCT01064440
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a gene therapy called VM202 (Engensis) in 52 people with critical limb ischemia, a severe form of leg artery disease that causes pain and can lead to amputation. Participants received either low-dose, high-dose, or placebo injections into their calf muscles. The goal was to see if the treatment is safe and can reduce pain and improve blood flow. Results will help decide if larger studies are warranted.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
VM202 (Engensis), a DNA plasmid given as injections into the calf muscle
What this could lead to
If successful, VM202 could offer a new way to reduce pain and improve blood flow in people with severe leg artery disease, potentially saving limbs from amputation.
What could go wrong
This is an early Phase 2 trial with only 52 participants, so results may not apply to everyone. The treatment involves multiple injections and may cause side effects; it is not yet proven to work better than placebo.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Boston University School of Medicine
Boston, Massachusetts, 02118, United States
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Cardiology PC
Birmingham, Alabama, 35211, United States
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Ewha Womans University Medical Center
Seoul, YangCheon-ku, 158-710, South Korea
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Jobst Vascular
Toledo, Ohio, 43506, United States
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Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
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Saint Louis University
St Louis, Missouri, 63110, United States
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Seoul National University
Seoul, Jongno-gu, 110-744, South Korea
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St. Vincent Medical Group
Indianapolis, Indiana, 46290, United States
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Texas Heart Institute
Houston, Texas, 77030, United States
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The Methodist Hospital
Houston, Texas, 77030, United States
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UNC School of Medicine
Chapel Hill, North Carolina, 27599, United States
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University of Minnesota
Minneapolis, Minnesota, 55454, United States
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University of Oklahoma HSC
Oklahoma City, Oklahoma, 73104, United States
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University of Utah
Salt Lake City, Utah, 84132, United States
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Vascular and Interventional Specialist of Orange County
Orange, California, 92868, United States
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Yonsei University Health System. Severance Cardiovascular Hospital
Seoul, Seodaemun-gu, 120-752, South Korea