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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02563522
Recruitment Status : Unknown
Verified August 2019 by Helixmith Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : September 30, 2015
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Helixmith Co., Ltd.

Study Description
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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 Design
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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
Actual 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

Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Helixmith Co., Ltd.
Investigators
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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
More Information
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Responsible Party: Helixmith Co., Ltd.
ClinicalTrials.gov Identifier: NCT02563522    
Other Study ID Numbers: VMNHU-003
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helixmith Co., Ltd.:
non healing ulcers
VM202
Diabetic ulcers
foot ulcers
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
 Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies