Evaluating a new procedure for patients with severe limb ischemia who have no other options

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the early safety and effectiveness of a novel procedure called percutaneous deep foot venous arterialization in patients with 'no-option' chronic limb-threatening ischemia (CLTI). The study will enroll patients who have previously undergone unsuccessful revascularization attempts and are at high risk for amputation. By utilizing the venous plexus of the foot as an alternative conduit for arterial flow, the study seeks to provide a potential solution for those with critical lower limb ischemia. Data will be collected on enrolled patients' demographics and medical history to evaluate outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years
* Patient has signed an approved informed consent form
* All patients, with non-revascularizable critical lower limb ischemia defined on the basis of 2 previous unsuccessful Percutaneous Transluminal Angioplasty (PTA) attempts or on severe Medial Artery Calcification (MAC)/Small Artery Disease (SAD) stage.
* Patient with Critical Limb Ischaemia, Rutherford category, 5 (minor tissue loss) or 6 (major tissue loss) with active trophic lesions
* Ejection Fraction \> 30%

Exclusion Criteria:

* Subject no able to perform the follow up or other factors making clinical follow-up difficult
* Patients with critical ischaemia of the lower limbs revascularizable by bypass or angioplasty, critical ischaemia characterised by rest pain (Rutherford class ≤ 4)
* Ejection Fraction \< 30%

Where it's running

• Irccs Inrca
  Ancona, Ancona, Italy Recruiting
• Ospedale San Martino
  Belluno, Italy, Italy Recruiting
• Ospedale Bufalini
  Cesena, Italy, Italy Recruiting
• Ospedale Cardarelli
  Naples, Italy, Italy Recruiting
• Ospedale Santa Chiara
  Trento, Italy, Italy Recruiting
• Ospedale Pederzoli
  Peschiera del Garda, Veneto, Italy Recruiting

Study contacts

• Principal investigator: Bruno Migliara, MD — Casa di Cura Pederzoli
• Study coordinator: Gabriele Morselli, PharmD
• Email: g.morselli@endocorelab.org
• Phone: +39 3499105666

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating full-body imaging technology for skin disease detection

  This study is testing a new full-body imaging technology to see if it can help doctors better detect and monitor skin diseases like skin cancer and eczema.

  Recruiting at 3 sites HJN Sverige AB/Neko Health · Stockholm and 2 other locations · NCT06989216

• Non-invasive imaging to measure skin composition and structure

  This study is testing a new non-invasive imaging technology to see if it can accurately measure different components and structures of skin in people visiting their primary care doctor, especially those at higher risk for heart issues or diabetes.

  Recruiting at 3 sites HJN Sverige AB/Neko Health · Stockholm and 2 other locations · NCT06976073

• Early angioplasty for diabetic foot syndrome

  This study is testing if getting a quick angioplasty after being diagnosed with diabetic foot ulcers helps heal the wounds better than waiting for the procedure.

  Recruiting Heinrich-Heine University, Duesseldorf · Düsseldorf · NCT06124586

• Registry of Chronic Wounds and Ulcers

  This study collects information from patients with chronic wounds and ulcers to see how well different treatments are working and to improve the quality of wound care.

  Recruiting U.S. Wound Registry · The Woodlands, Texas · NCT02280733

• Preventing lower limb artery disease in adults with diabetes using a risk-prediction model and HAPA-based nursing

  A risk-prediction model is tested in adults with type 2 diabetes to see if a nursing plan based on the HAPA model can reduce peripheral artery disease in the legs.

  Recruiting Second Affiliated Hospital of Nanchang University · Nanchang, Jang XI · NCT07881588

• Predictors of Major Adverse Limb Events After Iliac Artery Stenting

  This study tests what factors predict serious limb-related problems after iliac artery stenting in adults with peripheral artery disease.

  Recruiting I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Milan, Mi · NCT07672249

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.