The SPECTACULAR-study
- Conditions
- Peripheral arterial disease, PAD, Hyperspectral imaging, thermal imaging, tissue perfusion, tissue ischemia, wound healing
- Registration Number
- NL-OMON28679
- Lead Sponsor
- niversity Medical Centre Groningen Hanzeplein 1, 9713 GZ GroningenThe Netherlands
- Brief Summary
not applicable
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 652
Inclusion Criteria
Patients with Peripheral arterial disease, with Rutherford classification 2 to 6 and patients with undefined ulcers meet inclusion criteria.
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Patients with insufficient knowledge of the Dutch language, illiteracy or language barrier
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine normal ranges for oxyhemoglobin, deoxyhemoglobin, oxygen saturation and local skin temperature values during all stages and phases (pre-/per-/post-intervention) of treatment of peripheral arterial disease.
- Secondary Outcome Measures
Name Time Method To provide a standardized and validated measurement protocol for hyperspectral and thermal imaging with a hand-held camera, that enables non-invasive tissue perfusion imaging at home.<br /><br /><br><br>To correlate hyperspectral imaging and thermal imaging with the gold standard tcPO2.<br /><br /><br> <br>To correlate ankle brachial index (ABI), toe systolic blood pressure (TBP) and treadmill test with the gold standard tcPO2.<br /><br /><br><br>To associate oxyhemoglobin, deoxyhemoglobin and oxygen saturation levels and thermal imaging with:<br /><br>- Clinical improvement after intervention (supervised exercise therapy, endovascular intervention or bypass surgery). Including: Multivariate analysis with patient demographics and lifestyle (data gained from a questionnaire)<br /><br>- Wound healing (post-intervention and without intervention)<br /><br>- Origin of non-healing ulcer (arterial, venous or neuropathic (diabetes-related)<br>