Evaluating blood flow in patients with peripheral artery disease
Evaluation of Tissue Perfusion in Patients With Lower Extremity Peripheral Arterial Disease
This study is testing how blood flow changes in patients with peripheral artery disease before and after they have surgery to see if it helps with healing their wounds.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University Innsbruck Academic / other |
| Locations | 1 site (Innsbruck, Tyrol) |
| Trial ID | NCT05570019 on ClinicalTrials.gov |
What this trial studies
This observational study assesses arterial perfusion in patients with lower limb peripheral arterial disease using standard diagnostic tools such as toe pressure, trans-cutaneous oxygen pressure, ankle-brachial index, and fluorescence angiography. The study aims to evaluate changes in tissue perfusion before and after revascularization procedures, which may include open surgery or angioplasty. By quantifying tissue perfusion, the study seeks to inform treatment decisions regarding further revascularization and improve wound healing outcomes for patients with critical limb ischemia.
Who should consider this trial
Good fit: Ideal candidates are patients with symptomatic peripheral arterial disease requiring revascularization, specifically those classified under Rutherford categories 3-6.
Not a fit: Patients who may not benefit include those under 18 years old, those with certain allergies, or those with severely impaired kidney function.
Why it matters
Potential benefit: If successful, this study could enhance treatment strategies for patients with peripheral arterial disease, potentially leading to better wound healing and limb preservation.
How similar studies have performed: While the approach of evaluating tissue perfusion is established, this specific observational study may provide novel insights into its impact on treatment outcomes in peripheral arterial disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - patients with symptomatic peripheral arterial disease (Rutherford categories 3-6) requiring revascularization. Exclusion Criteria: * patients younger than 18 years * patients unable to give consent without legal guardians * iodine allergy * hyperthyroidism * allergy to indocyanine green * Glomerular filtration rate \<30ml/min/1.73m2
Where this trial is running
Innsbruck, Tyrol
- Department of Vascular Surgery, Medical University Innsbruck — Innsbruck, Tyrol, Austria (Recruiting)
Study contacts
- Study coordinator: Florian K Enzmann, MD, PhD
- Email: florian.enzmann@i-med.ac.at
- Phone: 004343512504
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.