Noninvasive assessment of blood flow in patients with chronic limb-threatening ischemia
Evaluation of Lower Limb Angiosome Perfusion and Oxygenation Using Thermal and Hyperspectral Imaging
This study is testing a new way to check blood flow and oxygen levels in the legs of people with chronic limb-threatening ischemia to see if it can help improve their diagnosis and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tampere University Academic / other |
| Locations | 1 site (Tampere, Pirkanmaa) |
| Trial ID | NCT05786001 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new diagnostic method using hyperspectral and thermal imaging to assess blood flow and oxygen levels in the lower limbs of individuals with chronic limb-threatening ischemia (CLTI). It aims to compare the results between patients with CLTI, healthy individuals, and those without cardiovascular diseases. The approach focuses on noninvasive techniques to improve the diagnosis and understanding of peripheral circulation issues. By analyzing perfusion and oxygenation, the study seeks to enhance the management of CLTI.
Who should consider this trial
Good fit: Ideal candidates include individuals over 50 years old diagnosed with CLTI or healthy individuals aged 18 to 50 without cardiovascular disease.
Not a fit: Patients unable to provide informed consent or those who deny participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for patients suffering from chronic limb-threatening ischemia.
How similar studies have performed: While the use of noninvasive imaging techniques is established, this specific multimodal approach for CLTI assessment is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * for CLTI patients age \>50 * for age control group age \>50 and not diagnosed with cardiovascular diseases. 0.9 \< ABI \< 1.3 * for healthy group 18 \<= age \<= 50 and no history of cardiovascular disease * volunteering for study Exclusion Criteria: * inability to give informed consent * denial
Where this trial is running
Tampere, Pirkanmaa
- Tampere University — Tampere, Pirkanmaa, Finland (Recruiting)
Study contacts
- Principal investigator: Niku Oksala, MD, PhD, DSc — Tampere University, Tampere University Hospital
- Study coordinator: Niku Oksala, MD, PhD, DSc
- Email: niku.oksala@tuni.fi
- Phone: +358 331 1611
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.