Last updated on July 2017

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


Brief description of study

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.

Detailed Study 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 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 -VM202 + standard of care - 200 patients - Control - Placebo (VM202 Vehicle) + standard of care - 100 patients

Clinical Study Identifier: NCT02563522

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Eric Espensen, DPM

University of Arizona
Tucson, AZ United States
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Christopher Rowlett, DPM

NEA Baptist
Jonesboro, AR United States
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Gregory Tovmassian, DPM

Center for Clinical Research Inc.
Carmichael, CA United States
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Mher Vartivarian, DPM

Center for Clinical Research Inc.
Castro Valley, CA United States
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Felix Sigal, DPM

Foot and Ankle Clinic
Los Angeles, CA United States
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Alexander Reyzelman, DPM

Center for Clinical Research Inc.
San Francisco, CA United States
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Aksone Nouvong, DPM

Olive View-UCLA Education & Research Institute
Sylmar, CA United States
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Jacob Silverstone, DPM

LCC Medical Research Institute
Miami, FL United States
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Francisco Oliva, DPM

Miami Dade Medical Research Institute, LLC
Miami, FL United States
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Robert Galiano, MD

Northwestern University
Chicago, IL United States
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Edward Arous, MD

UMASS Memorial Med Center
Worcester, MA United States
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Catherine Wittgen, MD

Saint Louis University
Saint Louis, MO United States
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Maria Kasper, DPM

Martin Foot and Ankle
York, PA United States
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Gil M Moreu, DPM

MedResearch, Inc
El Paso, TX United States
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Travis Motley, DPM

University of North Texas Health Science Center
Fort Worth, TX United States
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Emerson Perin, MD

Texas Heart Institute
Houston, TX United States
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Joe Pouzar, MD

Centex Studies, Inc.
Houston, TX United States
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