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

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: NCT02544204
Recruitment Status : Unknown
Verified November 2016 by Juventas Therapeutics, Inc..
Recruitment status was:  Recruiting
First Posted : September 9, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Juventas Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE August 6, 2015
First Posted Date  ICMJE September 9, 2015
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2015)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Disease
Intervention  ICMJE
  • Biological: JVS-100
    Biological/Vaccine: JVS-100 Intramuscular Injection
  • Biological: Placebo
    Biological/Vaccine: Placebo Intramuscular Injection
Study Arms  ICMJE
  • Active Comparator: 8 mg JVS-100
    Biological/Vaccine: JVS-100 Injection Intramuscular Injection
    Intervention: Biological: JVS-100
  • Placebo Comparator: 8 mg placebo
    Biological/Vaccine: Placebo Injection Intramuscular Injection
    Intervention: Biological: Placebo
  • Active Comparator: 16 mg JVS-100
    Biological/Vaccine: JVS-100 Injection Intramuscular Injection
    Intervention: Biological: JVS-100
  • Placebo Comparator: 16 mg placebo
    Biological/Vaccine: Placebo Injection Intramuscular Injection
    Intervention: Biological: Placebo
Publications * Shishehbor MH, Rundback J, Bunte M, Hammad TA, Miller L, Patel PD, Sadanandan S, Fitzgerald M, Pastore J, Kashyap V, Henry TD. SDF-1 plasmid treatment for patients with peripheral artery disease (STOP-PAD): Randomized, double-blind, placebo-controlled clinical trial. Vasc Med. 2019 Jun;24(3):200-207. doi: 10.1177/1358863X18817610. Epub 2019 Feb 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 4, 2015)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2017
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02544204
Other Study ID Numbers  ICMJE JTCS-007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juventas Therapeutics, Inc.
Study Sponsor  ICMJE Juventas Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Juventas Therapeutics, Inc.
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP