SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease

Status:	Recruiting
Conditions:	Peripheral Vascular Disease
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 85
Updated:	4/21/2016
Start Date:	November 2015
End Date:	November 2017

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 2 days and 3 months following the procedure.

Major Inclusion Criteria:

- Age 18 to 85 inclusive, currently receiving standard of care wound treatment for
chronic wounds or gangrene including as indicated: debridement, pressure offloading,
infection control, and/or maintenance of a moist wound environment.

- Diagnosis of advanced peripheral artery disease (PAD) with tissue loss (ulceration
and/or dry gangrene)

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

- toe brachial index (TBI) ≤ 0.51

- Toe pressure < 50 mmHg with flat or dampened wave forms

- Skin Perfusion pressure < 40 mmHg at mid foot level

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;

- Clinical evidence of invasive infection in the index leg

- Inability to safely perform a revascularization procedure due to uncontrolled
diabetes or other medical condition.

We found this trial at

sites

Deborah Heart and Lung Center

Browns Mills, New Jersey 08015

Phone: 609-893-1200

from

Browns Mills, NJ