No registrations found.
ID
Source
Brief title
Health condition
Peripheral arterial disease, PAD, Hyperspectral imaging, thermal imaging, tissue perfusion, tissue ischemia, wound healing
Sponsors and support
Hanzeplein 1, 9713 GZ Groningen
The Netherlands
IJsseldijk 222, 2924 AZ Krimpen aan den IJssel
Intervention
Outcome measures
Primary outcome
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
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.
To correlate hyperspectral imaging and thermal imaging with the gold standard tcPO2.
To correlate ankle brachial index (ABI), toe systolic blood pressure (TBP) and treadmill test with the gold standard tcPO2.
To associate oxyhemoglobin, deoxyhemoglobin and oxygen saturation levels and thermal imaging with:
- 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)
- Wound healing (post-intervention and without intervention)
- Origin of non-healing ulcer (arterial, venous or neuropathic (diabetes-related)
Background summary
To detect and determine the severity of PAD, effective diagnostics are necessary. Current diagnostic methods used for PAD can only detect arterial inflow but do not measure tissue perfusion, which has a crucial meaning for the clinical outcomes. Hyperspectral imaging is a novel, non-invasive method to determine tissue perfusion by measuring oxyhemoglobin, deoxyhemoglobin and oxygen saturation transcutaneous. Additionally, thermal imaging is a non-invasive method to determine local changes in skin temperature, which correlates with vascular disease and ulceration. Therefore, we hypothesize that hyperspectral imaging and thermal imaging can be used to assess tissue perfusion during the complete care process of patients with peripheral arterial disease.
Study objective
We hypothesize that Hyperspectral imaging and thermal imaging are optimal techniques to measure tissue perfusion, and in this way diagnose peripheral arterial disease and to determine the effect of the treatment.
Study design
Before, during and after treatment.
Intervention
none
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
Patients with severe peripheral oedema (will affect hyperspectral imaging and TcPO2)
Patient with severe cardiac-pulmonary failure
Patients with active cellulitis-erysipelas of the legs or other dermatological diseases (that will compromise tcPO2 of hyperspectral imaging measurements).
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7471 |
| NTR-old | NTR7713 |
| CCMO | NL68848.042.19 |
| OMON | NL-OMON48324 |