Wound Heal Clinical Trial
Official title:
Measurement of Revascularization Effect Using Near Infrared Spectroscopy in Below the Knee Arteries
NCT number | NCT03898869 |
Other study ID # | BTK-01 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 29, 2019 |
Est. completion date | January 2022 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | January 2022 |
Est. primary completion date | January 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 95 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Lithuania | Vilniaus Miesto Klinikine hospital | Vilnius |
Lead Sponsor | Collaborator |
---|---|
Vilnius University |
Lithuania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Increase in oxygen amount sufficient for wound healing | 12 months | ||
Secondary | Detection of early recoil after BTK revascularization | 1 hour |
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