Is NCT05313165 recruiting in Chicago, IL?

Yes, NCT05313165 is currently recruiting participants at its Chicago, IL location. This critical limb ischemia clinical trial is actively enrolling qualified participants.

How do I join the critical limb ischemia clinical trial in Chicago?

To join this clinical trial in Chicago, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Chicago clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Critical Limb Ischemia Clinical Trial in Chicago, IL

Who Can Participate

Inclusion Criteria

Subject must be ≥ 18 and ≤ 95 years of age

Clinical diagnosis of chronic limb-threatening ischemia, defined as any of the following clinical assessments: previous angiogram or hemodynamic evidence of severely diminished arterial inflow of the index limb (e.g., ABI ≤ 0.39, TP / TcPO2 \< 30 mm Hg) and

Rutherford Classification 5, ischemic ulceration or

Rutherford Classification 6, ischemic gangrene

Subject has been assessed by the Principal Investigator and determined that no conventional distal bypass, surgical or endovascular therapy for limb salvage is feasible due to either a) absence of a usable pedal artery target (endovascular or surgical approach), or b) the presence of a pedal artery target with absence of a viable single-segment vein in either lower extremity or either arm that could be used for autogenous vein conduit.

Proximally, the Target In-flow Artery at the cross-over point must fall within the recommended vessel diameter ranges for the LimFlow stent graft by visual estimation.

Subject is willing and able to sign the informed consent form.

Subject is enrolled in an acceptable wound care network and has an adequate support network to ensure that subject is compliant with medication regimen and follow-up study visits.

Prior to enrollment (7-day window), women of childbearing potential must have a negative pregnancy test.

Primary wound is stable (e.g., not rapidly deteriorating and/or showing signs of healing).

Stable glycemic control, HbA1C \< 10% (\<269mg/dL)

Subjects requiring dialysis may be included, provided they meet all the following requirements:

On dialysis for \> 6 months

Autologous arteriovenous (AV) fistula or peritoneal access used for hemodialysis

Serum albumin \> 30 g/liter

Exclusion Criteria

Concomitant hepatic insufficiency, thrombophlebitis in the target limb, or non-treatable coagulation disorder within the past 90 days.

Active immunodeficiency disorder or currently receiving immunosuppressant therapy for an immunodeficiency disorder.

Prior peripheral arterial bypass procedure above or below the knee which would inhibit proximal inflow to the stent graft.

Absence of adequate viable tissue in target foot.

Life expectancy less than 12 months.

Documented myocardial infarction or stroke within previous 90 days.

Active infection (e.g., fever, significantly elevated WBC count \>20.0 x 109/L, and/or positive blood culture) at the time of the index procedure that may preclude insertion of a prosthesis or require major amputation (e.g., osteomyelitis proximal to metatarsals).

Known or suspected allergies or contraindications to aspirin or P2Y12 inhibitors, heparin, stainless steel, nitinol or contrast agent that cannot be adequately pre-treated.

Subject is currently taking anti-coagulants, which in the opinion of the investigator, interferes with the subject's ability to participate in the study (i.e., intermittent interruption of therapy for procedure may compromise subject's safety).

Lower extremity vascular disease that may inhibit the procedure and/or jeopardize wound healing (e.g., vasculitis, Buerger's disease, significant edema in the target limb, deep venous thrombus in the target vein, hyperpigmentation, or medial ulceration above the ankle).

Significant acute or chronic kidney disease with a serum creatinine of \> 2.5 mg/dl in subjects not undergoing dialysis.

Severe heart failure (e.g., NYHA Class IV), which in the opinion of the investigator may compromise subject's ability to safely undergo a percutaneous procedure.

Any significant concurrent medical, psychological, or social condition, which may significantly interfere with the subject's optimal participation in the study, in the opinion of the investigator.

The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.

Subject is unwilling, unable, or unlikely for cognitive or social reasons to comply with any of the protocol or follow-up requirements.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Chicago?

Yes, this clinical trial (NCT05313165) has an active research site in Chicago, IL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Critical Limb Ischemia Treatment Options in Chicago, IL

If you're searching for critical limb ischemia treatment options in Chicago, IL, this clinical trial (NCT05313165) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Chicago research site is actively enrolling participants for this clinical trial. You'll receive care from experienced critical limb ischemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all critical limb ischemia clinical trials near you to find additional studies recruiting in your area.

Critical Limb Ischemia Clinical Trial in Chicago, IL

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