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

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ClinicalTrials.gov Identifier: NCT02563522
Recruitment Status : Recruiting
First Posted : September 30, 2015
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
ViroMed Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Foot Ulcer, Diabetic Genetic: VM202 Drug: Placebo Phase 3

Detailed 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Active: VM202 + standard of care - 200 subjects Control: Placebo (VM202 vehicle) + standard of care - 100 subjects
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : January 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Active Comparator: Active
VM202 + standard of care
Genetic: VM202
gene therapy

Placebo Comparator: Control
Placebo (VM202 Vehicle) + standard of care
Drug: Placebo
Standard of care plus placebo
Other Name: VM202 vehicle




Primary Outcome Measures :
  1. Confirmed target wound closure by the 4 month follow-up [ Time Frame: 0-4 Months ]

Secondary Outcome Measures :
  1. Time to complete wound closure of foot ulcer [ Time Frame: Days 0 to Month 7 ]
    The time until confirmed target wound closure

  2. Time to the amputations [ Time Frame: Day 0 to Month 7 ]
    how long until amputation occurred

  3. Change in ankle brachial index (ABI) [ Time Frame: at 4 months, and 7 months ]
    change in ABI at 4 and 7 months

  4. Change in toe brachial index (TBI) [ Time Frame: at 4 months, and 7 months ]
    Change in TBI at 4 and 7 months

  5. Change in score of each domain on the CWIQ [ Time Frame: from baseline at 4 months and 7 month ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563522


Contacts
Contact: Sheila Yi sheila@viromed.co.kr

Locations
United States, Alabama
Central Research Associates, Inc. Recruiting
Birmingham, Alabama, United States, 35205
Contact: William Whitley, Pharm D         
Principal Investigator: Jeffrey Davis, MD         
United States, Arizona
Arizona Research Center Recruiting
Phoenix, Arizona, United States, 85053
Principal Investigator: Joseph Gimbel, MD         
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Principal Investigator: Eric Espensen, DPM         
United States, Arkansas
NEA Baptist Recruiting
Jonesboro, Arkansas, United States, 72401
Principal Investigator: Christopher Rowlett, DPM         
United States, California
Sacramento Foot and Ankle Recruiting
Carmichael, California, United States, 95608
Principal Investigator: Gregory Tovmassian, DPM         
Bay Area Foot and Ankle Recruiting
Castro Valley, California, United States, 94546
Principal Investigator: Mher Vartivarian, DPM         
VA Long Beach Healthcare System Recruiting
Long Beach, California, United States, 90822
Principal Investigator: Ian Gordon, MD         
Foot and Ankle Clinic Recruiting
Los Angeles, California, United States, 90057
Principal Investigator: Felix Sigal, DPM         
USC Keck School of Medicine Recruiting
Los Angeles, California, United States
Principal Investigator: David Armstrong         
Center for Clinical Research Inc. Recruiting
San Francisco, California, United States, 94115
Principal Investigator: Alexander Reyzelman, DPM         
Olive View-UCLA Education & Research Institute Recruiting
Sylmar, California, United States, 91342
Principal Investigator: Aksone Nouvong, DPM         
United States, Florida
LCC Medical Research Institute Recruiting
Miami, Florida, United States, 33126
Contact: , MD         
Principal Investigator: Jacob Silverstone, DPM         
Miami Dade Medical Research Institute, LLC Recruiting
Miami, Florida, United States, 33176
Principal Investigator: Francisco Oliva, DPM         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Karen Ho, MD         
United States, Massachusetts
UMASS Memorial Med Center Recruiting
Worcester, Massachusetts, United States, 01655
Principal Investigator: Edward Arous, MD         
United States, Missouri
Saint Louis University Recruiting
Saint Louis, Missouri, United States, 63110
Principal Investigator: Catherine Wittgen, MD         
United States, Nevada
Advanced Foot & Ankle Center Recruiting
Las Vegas, Nevada, United States, 89119
Principal Investigator: Cyaandi Dove, DPM         
United States, Oregon
Oregon Foot and Ankle Center Recruiting
Eugene, Oregon, United States, 97401
Principal Investigator: Lacey Loveland, DPM         
United States, Texas
MedResearch, Inc Recruiting
El Paso, Texas, United States, 79932
Principal Investigator: Gil M Moreu, DPM         
Acclaim Bone & Joint Institute Recruiting
Fort Worth, Texas, United States, 76107
Principal Investigator: Travis Motley, DPM         
Texas Heart Institute Recruiting
Houston, Texas, United States, 77030
Contact: Nichole Piece         
Principal Investigator: Emerson Perin, MD         
Futuro Clinical Trials Recruiting
McAllen, Texas, United States, 78501
Principal Investigator: Joseph Caporusso, DPM         
Sponsors and Collaborators
ViroMed Co., Ltd.
Investigators
Principal Investigator: Emerson C. Perin, MD Texas Heart Institute
Principal Investigator: David G Armstrong,, DPM, MD, PhD Keck School of Medicine of University of Southern California

Responsible Party: ViroMed Co., Ltd.
ClinicalTrials.gov Identifier: NCT02563522     History of Changes
Other Study ID Numbers: VMNHU-003
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ViroMed Co., Ltd.:
non healing ulcers
VM202
Diabetic ulcers
foot ulcers

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Peripheral Arterial Disease
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Diabetic Angiopathies
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies