Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Juventas Therapeutics, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
* TBI ≤ 0.51or;
* Toe pressure ≤50 mmHg with flat or dampened wave forms or;
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
You may not be if
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
Clareo Health | SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease
