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Trial record 3 of 7 for:    Juventas

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

This study is currently recruiting participants.
Verified November 2016 by Juventas Therapeutics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02544204
First Posted: September 9, 2015
Last Update Posted: November 2, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Juventas Therapeutics, Inc.
  Purpose
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.

Condition Intervention Phase
Peripheral Arterial Disease Biological: JVS-100 Biological: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Juventas Therapeutics, Inc.:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: November 2015
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT02544204


  Show 24 Study Locations
Sponsors and Collaborators
Juventas Therapeutics, Inc.
  More Information

Responsible Party: Juventas Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02544204     History of Changes
Other Study ID Numbers: JTCS-007
First Submitted: August 6, 2015
First Posted: September 9, 2015
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs