Ischemic Feet, Percutaneous Transluminal Angioplasty, Wound Heal
Conditions
Brief summary
Patient with occluded below the knee arteries and chronic limb ischemia Rutherford class V-VI are enrolled. During endovascular recanalisation procedure changes in tissue oxygen amount is recorded using near infrared spectroscopy (NIRS). Primary hypothesis - NIRS can be used to determine sufficient amount of blood reaching the ulcered ishemic area. Secondary hypothesis - NIRS can be useful in detecting early recoil after BTK recanalisation.
Interventions
DIAGNOSTIC_TESTIntraoperative NIRS monitoring
Near infrared spectroscopy non invasively used to register changes in tissue oxygen amount during endovascular revascularization
Sponsors
Vilnius University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Critical limb ischemia Rutherford V-VI * At least one artery below the knee is planned to revascularize
Exclusion criteria
* Blood oxygen saturation below 85% because of any comorbidities * Life expectancy less than 12 months * Unavoidable amputation above ankle * Skin diseases preventing the use of NIRS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in oxygen amount sufficient for wound healing | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Detection of early recoil after BTK revascularization | 1 hour |
Countries
Lithuania
Contacts
Primary ContactTomas Baltrūnas
Outcome results
None listed