A multicentre study to use non-invasive methods including hyperSPECTral imaging, thermal imaging and tcPO2 for monitoring tissue perfusion in vAsCULAR patients in-hospital and at home -- The SPECTACULAR-study
Completed
- Conditions
- Peripheral arterial disease - Constricted bloodflow to the legs10003216
- Registration Number
- NL-OMON48324
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 432
Inclusion Criteria
Patients who are 18 years and older with peripheral arterial disease; non- critical limb ischemia (Rutherford classification 2 and 3) or critical limb ischemia (Rutherford classification 4 to 6). Written informed consent
Exclusion Criteria
Patients with insufficient knowledge of the Dutch language, illiteracy or language barrier
Patients with severe peripheral oedema.
Patient with severe cardiac-pulmonary failure
Patients with active cellulitis-erysipelas of the legs or other dermatological diseases of the legs.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter are the longitudinal trends of oxyhemoglobin,<br /><br>deoxyhemoglobin and oxygen saturation, local temperature and tcPO2 measurements<br /><br>during various phases of peripheral arterial disease, pre-, per-, and<br /><br>post-intervention. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints in this study are, correlation between hyperspectral<br /><br>imaging, thermal imaging, tcPO2 measurements and ABI, TBP and treadmill test<br /><br>and degree of stenosis on CTA. Additionally, hyperspectral imaging, thermal<br /><br>imaging tcPO2 measurements are associated with wound healing, clinical outcome<br /><br>(increased walking distance, (re-) intervention) and origin of ulceration<br /><br>(arterial or not arterial). </p><br>