The SPECTACULAR-study

A multicentre study to use non-invasive methods including hyperSPECTral imaging for monitoring tissue perfusion in vAsCULAR patients in-hospital and at home.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON28679

Enrollment

652

Registered

2019-01-21

Start date

2019-02-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral arterial disease, PAD, Hyperspectral imaging, thermal imaging, tissue perfusion, tissue ischemia, wound healing

Interventions

none

Eligibility

Inclusion criteria

Inclusion criteria: Patients with Peripheral arterial disease, with Rutherford classification 2 to 6 and patients with undefined ulcers meet inclusion criteria.

Exclusion 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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)