Peripheral artery disease
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 18 years or older; written informed consent and; chronic limb threatening ischemia (Rurtherford 4-6) at the leg that will be revascularized
Exclusion criteria
Exclusion criteria: Insufficient knowledge of the Dutch language, illiteracy, language barrier or not compos mentis; lower leg fractures within the past 12 months; (partial) amputation of one of the feet and/or legs; Rutherford 4-6 at the contralateral leg; pregnant or breast feeding; severe peripheral oedema; taller than 1,90 m (because of the limited field of view of the PET scanner; the PET camera only measures 1.06m and we want to picture the entire legs); not able to lay supine for 6 minutes; acute ischemia and; severe claustrophobia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint of this study is to correlate regional muscle tissue perfusion measured with [15O] H2O PET to local skin tissue perfusion measured with TcPO2. We will have measurements of both legs of 15 patients, who will undergo a [15O] H2O PET scan and local skin perfusion measurements at 4 locations twice (before and after the intervention). | — |
Secondary
| Measure | Time frame |
|---|---|
| A secundary parameter is is to correlate pre-intervention tissue perfusion (measured with [15O] H2O PET and TcPO2) with post-intervention tissue perfusion. We will also correlate these parameters with arterial blood pressure (ABI and TBP). Antoher secudnarry parameter is the inter- and intra-rater variability between two researchers who perform measurements on the [15O] H2O PET-scans. | — |
Countries
Netherlands