Clinical trial NCT02544204: SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Peripheral Arterial Disease
Lead sponsor: Juventas Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
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.
timeFrame: 3 months
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.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiovascular Associates of the Southeast
state: Alabama
city: Davis
country: United States
facility: UC Davis
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Heart Institute
state: California
city: Washington
country: United States
facility: MedStar Georgetown UH
state: District of Columbia
city: Clearwater
country: United States
facility: Morton Plant Hosptial - Baycare
state: Florida
city: Miami
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Hospital
state: Florida
city: Chicago
country: United States
facility: Northwestern
state: Illinois
city: Chicago
country: United States
facility: RUMC
state: Illinois
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Detroit
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: Rochester
country: United States
facility: Mayo
state: Minnesota
city: Tupelo
country: United States
facility: Cardiology Associates Research
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Mid America Heart Institute
state: Missouri
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Chapel Hill
country: United States
facility: UNC
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart and Vascular Research
state: North Carolina
city: Akron
country: United States
facility: Summa Health
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Cleveland
country: United States
facility: Metro Health
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
city: Providence
country: United States
facility: Lifespan Health System
state: Rhode Island
city: Richmond
country: United States
facility: VCU
state: Virginia
city: Milwauke
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
citation: Hammad TA, Rundback J, Bunte M, Miller L, Patel PD, Sadanandan S, Fitzgerald M, Pastore J, Kashyap V, Henry TD, Shishehbor MH. Stromal Cell-Derived Factor-1 Plasmid Treatment for Patients With Peripheral Artery Disease (STOP-PAD) Trial: Six-Month Results. J Endovasc Ther. 2020 Aug;27(4):669-675. doi: 10.1177/1526602820919951. Epub 2020 May 18.
citation: 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.