Recruiting

Phase 2

SDF1 PlasmidSDF1 Plasmid Treatment for Patients With Peripheral Artery Disease

Sponsor:

Juventas Therapeutics, Inc.

Code:

NCT02544204

Conditions

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JVS-100

Placebo

Study Details

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.

Conditions

Peripheral Arterial Disease

Study ID

NCT02544204

Start date

Nov, 2015

Status verified date

Nov, 2016

Completion date

Nov, 2017

Anticipated

Primary completion date

Sep, 2017

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 8 mg JVS-100

Biological/Vaccine: JVS-100 Injection Intramuscular Injection

placebo comparator: 8 mg placebo

Biological/Vaccine: Placebo Injection Intramuscular Injection

active comparator: 16 mg JVS-100

Biological/Vaccine: JVS-100 Injection Intramuscular Injection

placebo comparator: 16 mg placebo

Biological/Vaccine: Placebo Injection Intramuscular Injection

Interventions

JVS-100

Biological/Vaccine: JVS-100 Intramuscular Injection

Placebo

Biological/Vaccine: Placebo Intramuscular Injection

Primary outcome measure

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 ]
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 ]

Central Contacts and Locations

Locations

UC Davis

Recruiting

Davis, California, United States

Contacts

John Laird, MD

916-734-4156

Cedars-Sinai Heart Institute

Recruiting

Los Angeles, California, United States

Contacts

Tim Henry, MD

310-423-1231

Morton Plant Hosptial - Baycare

Recruiting

Clearwater, Florida, United States

Contacts

Les Miller, MD

727-489-2543

Mount Sinai Medical Center

Recruiting

Miami, Florida, United States

Contacts

Nirat Beohar, MD

305-674-2121

St. Joseph's Hospital

Recruiting

Tampa, Florida, United States, 33614

Contacts

Sai Sadanandan, MD

813-875-9000

Northwestern

Recruiting

Chicago, Illinois, United States

Contacts

Karen Ho, MD

513-585-1777

RUMC

Recruiting

Chicago, Illinois, United States

Contacts

Jeff Snell, MD

312-942-8707

Cardiovascular Institute of the South

Recruiting

Houma, Louisiana, United States

Contacts

Craig Walker, MD

985-873-5613

St. John Hospital and Medical Center

Recruiting

Detroit, Michigan, United States

Contacts

Tom Davis, MD

313-343-4714

Mayo

Recruiting

Rochester, Minnesota, United States

Contacts

Sanjay Misra, MD

507-538-6419

Cardiology Associates Research

Recruiting

Tupelo, Mississippi, United States

Contacts

Murray Estess, MD

662-377-5447

St. Luke's Mid America Heart Institute

Recruiting

Kansas City, Missouri, United States

Contacts

Matt Bunte, MD

816-932-4948

Holy Name Medical Center

Recruiting

Teaneck, New Jersey, United States

Contacts

John Runback, MD

201-530-7968

UNC

Recruiting

Chapel Hill, North Carolina, United States

Contacts

William Marston, MD

919-843-1268

NC Heart and Vascular Research

Recruiting

Raleigh, North Carolina, United States

Contacts

Matt Hook, MD

919-740-4897

Summa Health

Recruiting

Akron, Ohio, United States

Contacts

Justin Dunn, MD

330-253-8195

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States

Contacts

Mehdi Shishehbor, DO

216-444-0922

Metro Health

Recruiting

Cleveland, Ohio, United States

Contacts

Sanjay Gandhi, MD

216-778-2714

University Hospitals

Recruiting

Cleveland, Ohio, United States

Contacts

Vikram Kashyap, MD

216-983-4719

Lifespan Health System

Recruiting

Providence, Rhode Island, United States

Contacts

Peter Soukas, MD

401-793-4105

VCU

Recruiting

Richmond, Virginia, United States

Contacts

Luis Guzman, MD

804-628-2452

Medical College of Wisconsin

Recruiting

Milwauke, Wisconsin, United States

Contacts

James Gossett, MD

414-955-6749

More Information

Sponsor

Juventas Therapeutics, Inc.

Last update posted

Nov 2, 2016

Last verified

Nov, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Juventas Therapeutics, Inc. on 2016-11-02.