chronic limb threatening ischemia chronic oxygen deficiency in the leg vessels
Conditions
Interventions
None listed
Sponsors
Ziekenhuisgroep Twente
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with ischemic foot ulcers >=18 years of age Planned to receive revascularization treatment by standard care practice protocol. Willing to give written informed consent and willing and able to comply with the study protocol Fontaine 3 and 4
Exclusion criteria
Exclusion criteria: - Patients with contact restrictions. - Forefoot amputation or larger - Patients with large wounds or severe gangrene will be excluded when this would make applying the TcPO2 suction cups impossible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LSCI (Perfusion Units) at specific regions or over time. Oxygen (TcPO2) pressure in mmHg per measurement location and over time Clinical outcome using multiple parameters derived from the patient files, such as wound healing (time to), successful revascularization (based on DSA), ankle brachial index, toe pressure, amputation yes/no, wound status (WiFi classification) and VAS score | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective 1,2 and 3, are needed to answer the main objective and therefore use the same parameters. Objective 4 will use additional regions of interest (measured in Perfusion Units) to determine the distribution of LSCI perfusion units in the presence of an ulcer. | — |
Countries
Netherlands
Outcome results
None listed