SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease (STOP-PAD)

November 1, 2016 updated by: Juventas Therapeutics, Inc.

A Phase 2B Randomized Double Blind Placebo Controlled Study to Evaluate the Safety and Efficacy of JVS-100 Administered by Direct Intramuscular Injection as Adjunct to Revascularization of Infrapopliteal Lesions in Subjects With Advanced Peripheral Artery Disease and Tissue Loss

To investigate the efficacy of the administration of JVS-100 delivered via direct intramuscular injections on a 3 month and 6 month composite endpoint of wound progression, healing and limb loss in patients with severe peripheral arterial disease with non-healing chronic wounds who undergo an open bypass grafting or endovascular procedure for treatment of infrapopliteal disease and are dosed within 12 days and 3 months following the procedure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Not yet recruiting
        • Cardiovascular Associates of the Southeast
        • Contact:
          • Chris Huff, MD
          • Phone Number: 205-795-5193
    • California
      • Davis, California, United States
        • Recruiting
        • UC Davis
        • Contact:
          • John Laird, MD
          • Phone Number: 916-734-4156
      • Los Angeles, California, United States
        • Recruiting
        • Cedars-Sinai Heart Institute
        • Contact:
          • Tim Henry, MD
          • Phone Number: 310-423-1231
    • District of Columbia
      • Washington, District of Columbia, United States
        • Not yet recruiting
        • MedStar Georgetown UH
        • Contact:
          • Paul Kim, MD
          • Phone Number: 202-444-0793
    • Florida
      • Clearwater, Florida, United States
        • Recruiting
        • Morton Plant Hosptial - Baycare
        • Contact:
          • Les Miller, MD
          • Phone Number: 727-489-2543
      • Miami, Florida, United States
        • Recruiting
        • Mount Sinai Medical Center
        • Contact:
          • Nirat Beohar, MD
          • Phone Number: 56022 305-674-2121
      • Tampa, Florida, United States, 33614
        • Recruiting
        • St. Joseph's Hospital
        • Contact:
          • Sai Sadanandan, MD
          • Phone Number: 813-875-9000
    • Illinois
      • Chicago, Illinois, United States
        • Recruiting
        • Northwestern
        • Contact:
          • Karen Ho, MD
          • Phone Number: 513-585-1777
      • Chicago, Illinois, United States
        • Recruiting
        • RUMC
        • Contact:
          • Jeff Snell, MD
          • Phone Number: 312-942-8707
    • Louisiana
      • Houma, Louisiana, United States
        • Recruiting
        • Cardiovascular Institute of the South
        • Contact:
          • Craig Walker, MD
          • Phone Number: 985-873-5613
    • Michigan
      • Detroit, Michigan, United States
        • Recruiting
        • St. John Hospital and Medical Center
        • Contact:
          • Tom Davis, MD
          • Phone Number: 313-343-4714
    • Minnesota
      • Rochester, Minnesota, United States
        • Recruiting
        • Mayo
        • Contact:
          • Sanjay Misra, MD
          • Phone Number: 507-538-6419
    • Mississippi
      • Tupelo, Mississippi, United States
        • Recruiting
        • Cardiology Associates Research
        • Contact:
          • Murray Estess, MD
          • Phone Number: 662-377-5447
    • Missouri
      • Kansas City, Missouri, United States
        • Recruiting
        • St. Luke's Mid America Heart Institute
        • Contact:
          • Matt Bunte, MD
          • Phone Number: 816-932-4948
    • New Jersey
      • Teaneck, New Jersey, United States
        • Recruiting
        • Holy Name Medical Center
        • Contact:
          • John Runback, MD
          • Phone Number: 201-530-7968
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • Recruiting
        • UNC
        • Contact:
          • William Marston, MD
          • Phone Number: 919-843-1268
      • Raleigh, North Carolina, United States
        • Recruiting
        • NC Heart and Vascular Research
        • Contact:
          • Matt Hook, MD
          • Phone Number: 919-740-4897
    • Ohio
      • Akron, Ohio, United States
        • Recruiting
        • Summa Health
        • Contact:
          • Justin Dunn, MD
          • Phone Number: 4259 330-253-8195
      • Cleveland, Ohio, United States
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • Mehdi Shishehbor, DO
          • Phone Number: 216-444-0922
      • Cleveland, Ohio, United States
        • Recruiting
        • Metro Health
        • Contact:
          • Sanjay Gandhi, MD
          • Phone Number: 216-778-2714
      • Cleveland, Ohio, United States
        • Recruiting
        • University Hospitals
        • Contact:
          • Vikram Kashyap, MD
          • Phone Number: 216-983-4719
    • Rhode Island
      • Providence, Rhode Island, United States
        • Recruiting
        • Lifespan Health System
        • Contact:
          • Peter Soukas, MD
          • Phone Number: 401-793-4105
    • Virginia
      • Richmond, Virginia, United States
        • Recruiting
        • VCU
        • Contact:
          • Luis Guzman, MD
          • Phone Number: 804-628-2452
    • Wisconsin
      • Milwauke, Wisconsin, United States
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • James Gossett, MD
          • Phone Number: 414-955-6749

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Major Inclusion Criteria:

  • Age ≥18
  • Currently receiving standard of care wound treatment (>2 weeks) for chronic wounds or gangrene including as indicated: debridement, pressure offloading, infection control, and/or maintenance of a moist wound environment.
  • Diagnosis of advanced PAD with tissue loss (ulceration and/or dry gangrene) on the foot of the index leg with an ulcer size of at least 0.5 cm2 and <25 cm2. Index wounds on the heel must be <10 cm2 that cannot be probed to bone, have exposed bone or osteomyelitis.

  • Post revascularization intervention inclusion criteria include an attempt at open bypass grafting or endovascular intervention of a popliteal/infrapopliteal lesion(s) on the same leg that has tissue loss without significant improvement in TBI post intervention. The following will be accepted as demonstrating a lack of post intervention toe brachial index (TBI) improvement:

    • TBI ≤ 0.51or;
    • Toe pressure ≤50 mmHg with flat or dampened wave forms or;
    • Skin Perfusion pressure ≤40 mmHg at mid foot level or;
    • TcPO2 ≤40 mmHg
  • Subjects willing to forgo treatment with hyperbaric oxygen, nerve stimulation or sympathectomy for the treatment of advanced PAD from time of consent to 6 months following the initial injection of study drug

Major Exclusion Criteria:

  • Previous major amputation of the leg to be treated or planned major amputation or transmetatarsal amputation within the first month following enrollment.
  • Only a short segment superficial femoral artery lesion - consistent with Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) A or B category, and no infrapopliteal disease
  • Staged or planned intervention in the index leg within 30 days after the index procedure
  • Acute limb-threatening ischemia, trauma, known non-atherosclerotic vascular disease
  • Non-salvageable limb defined as major tissue loss and an unsalvageable foot;
  • Wounds that have decreased in size by >50% between the Screening visit and Day 0.
  • If patient has active infection of the index limb that is being treated, and, in the opinion of treating physician, will not lead to an amputation within the next 3 months, the patient can be enrolled.
  • Inability to safely perform a revascularization procedure due to uncontrolled diabetes or other medical condition.
  • Presence of any other condition that, in the opinion of the investigator, might compromise any aspect of the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 8 mg JVS-100
Biological/Vaccine: JVS-100 Injection Intramuscular Injection
Biological: JVS-100
Biological/Vaccine: JVS-100 Intramuscular Injection
Placebo Comparator: 8 mg placebo
Biological/Vaccine: Placebo Injection Intramuscular Injection
Biological: Placebo
Biological/Vaccine: Placebo Intramuscular Injection
Active Comparator: 16 mg JVS-100
Biological/Vaccine: JVS-100 Injection Intramuscular Injection
Biological: JVS-100
Biological/Vaccine: JVS-100 Intramuscular Injection
Placebo Comparator: 16 mg placebo
Biological/Vaccine: Placebo Injection Intramuscular Injection
Biological: Placebo
Biological/Vaccine: Placebo Intramuscular Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The composite is designed to quantify clinically significant improvement or worsening over baseline by assigning a score to each patient that represents their overall outcome.
Time Frame: 3 months
Change from baseline in the composite endpoint at 3 months in all treated (or one JVS-100 dose group) compared to all placebo.
3 months
The composite is designed to quantify clinically significant improvement or worsening over baseline by assigning a score to each patient that represents their overall outcome.
Time Frame: 6 months
Change from baseline in the composite endpoint at 6 months in all treated (or one JVS-100 dose group) compared to all placebo.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juventas Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

September 4, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JTCS-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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