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



Status:Recruiting
Conditions:Gastrointestinal, Podiatry, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 80
Updated:11/3/2018
Start Date:January 2017
End Date:December 2019
Contact:Sheila Yi
Email:sheila@viromed.co.kr

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A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Asses the Safety and Efficacy of VM202 to Treat Chronic Nonhealing Foot Ulcers in Diabetic Patients With Concomitant Peripheral Arterial Disease (PAD)

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.

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

Inclusion Criteria:

- Documented symptomatic PAD

- Documented history of Type I or II diabetes with current treatment control (HbA1c of ≤
12.0% at Screening) and currently on oral medication and / or insulin

- No significant changes anticipated in diabetes medication regimen

- At Screening, subject has one ulcer on the target foot

- Subjects will undergo protocol-defined standardized wound care during screening (for
two weeks or longer).

Exclusion Criteria:

- Will require revascularization in the target leg within 3 months of randomization

- In the investigator's assessment, will require an amputation in the target leg within
3 months of randomization

- Subject diagnosed with critical limb ischemia (CLI; Rutherford score ≥ 4)

- Evidence of active infection (e.g., cellulitis, osteomyelitis) or deep ulceration
exposing bone or tendon in the foot planned for treatment

- Current fracture in the target foot

- Heart Failure with a New York Heart Association (NYHA) classification of III or IV;

- Body mass index (BMI) > 45 kg/m2 at Screening

- Unstable angina
We found this trial at
22
sites
303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Karen Ho, MD
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Chicago, IL
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Birmingham, Alabama 35205
Principal Investigator: Jeffrey Davis, MD
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Birmingham, AL
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Carmichael, California 95608
Principal Investigator: Gregory Tovmassian, DPM
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Carmichael, CA
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Castro Valley, California 94546
Principal Investigator: Mher Vartivarian, DPM
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Castro Valley, CA
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El Paso, Texas 79935
Principal Investigator: Gil M Moreu, DPM
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El Paso, TX
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Eugene, Oregon 97401
Principal Investigator: Lacey Loveland, DPM
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from
Eugene, OR
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Fort Worth, Texas 76107
Principal Investigator: Travis Motley, DPM
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Fort Worth, TX
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Houston, Texas 77225
Principal Investigator: Emerson Perin, MD
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Houston, TX
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Jonesboro, Arkansas 72401
Principal Investigator: Christopher Rowlett, DPM
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Jonesboro, AR
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Las Vegas, Nevada 89119
Principal Investigator: Cyaandi Dove, DPM
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Las Vegas, NV
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Long Beach, California 90822
Principal Investigator: Ian Gordon, MD
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Long Beach, CA
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Los Angeles, California 90010
Principal Investigator: Felix Sigal, DPM
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Los Angeles, CA
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Los Angeles, California 90033
Principal Investigator: David Armstrong
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from
Los Angeles, CA
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McAllen, Texas 78501
Principal Investigator: Joseph Caporusso, DPM
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from
McAllen, TX
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Miami, Florida 33126
Principal Investigator: Jacob Silverstone, DPM
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from
Miami, FL
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286 Westward Drive
Miami, Florida 33176
Principal Investigator: Francisco Oliva, DPM
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Miami, FL
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Phoenix, Arizona 85023
Principal Investigator: Joseph Gimbel, MD
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from
Phoenix, AZ
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Saint Louis, Missouri 63110
Principal Investigator: Catherine Wittgen, MD
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from
Saint Louis, MO
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San Francisco, California 94115
Principal Investigator: Alexander Reyzelman, DPM
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San Francisco, CA
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14445 Olive View Drive
Sylmar, California 91342
Principal Investigator: Aksone Nouvong, DPM
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Sylmar, CA
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Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Eric Espensen, DPM
University of Arizona The University of Arizona is a premier, public research university. Established in...
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Tucson, AZ
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Worcester, Massachusetts 01605
Principal Investigator: Edward Arous, MD
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Worcester, MA
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