The Application of Digital Infrared Thermal Imaging in Peripheral Artery Disease of the Lower Extremities
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|ClinicalTrials.gov Identifier: NCT02783677|
Recruitment Status : Unknown
Verified January 2017 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : May 26, 2016
Last Update Posted : February 6, 2017
Peripheral artery disease (PAD) is highly prevalent. It occurs most often in the lower extremities. Symptoms include intermittent claudication, ischemic pain, ulceration and necrosis. Amputation may be necessary in severe cases. PAD is also an indicator of future cerebrovascular and cardiovascular events. Diabetes mellitus (DM) is one of the major risk factors of PAD. Approximately 5% to 10% of diabetic patients have had foot ulceration, and 1% have undergone amputation. Other risk factors include smoking, old age, male gender, hypertension, dyslipidemia, hyperhomocysteinemia and renal insufficiency. Ankle-brachial index (ABI) is the most popular tool used to screen PAD. Doppler-derived ankle and brachial systolic pressure is obtained. If the ratio is abnormal, further confirmation studies will necessary. Although ABI is recommended as one of the screening tests for diabetic complications in guidelines, its utility is limited in calcified non-compressible vessels, which are common in DM and renal failure patients.
Digital infrared thermal imaging (DITI) is used to detect surface temperature because objects of absolute temperatures higher than zero would radiate electromagnetic waves of certain wave lengths according to Plank's law. DITI examination is non-invasive, non-contact and fast. Theoretically, temperature of the perfusion area of the occlusive arteries will decrease. Investigators will analyze DITI of PAD, and observe the relationship between DITI, ABI and vascular duplex examination. The dynamic change of DITI before and after percutaneous transluminal angioplasty of PAD will also be observed. Investigators would like to evaluate the possibility of the clinical application of DITI for PAD screening.
|Condition or disease||Intervention/treatment|
|Peripheral Artery Disease Diabetes Mellitus||Procedure: Percutaneous balloon angioplasty|
|Study Type :||Observational|
|Estimated Enrollment :||230 participants|
|Official Title:||The Application of Digital Infrared Thermal Imaging in Peripheral Artery Disease|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2020|
DM with PAD before angioplasty
Diabetic patients diagnosed with peripheral artery disease via vascular Duplex.
DM without PAD
Diabetic patients diagnosed without peripheral artery disease via vascular Duplex.
DM with PAD after angioplasty
Diabetic patients diagnosed with PAD underwent balloon-angioplasty
Procedure: Percutaneous balloon angioplasty
- Digital infrared thermal imaging (DITI) [ Time Frame: 7 days ]Digital infrared thermal imaging (DITI) to detect surface temperature
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783677
|National Taiwan University Hospital Taipei, Taiwan||Recruiting|
|Contact: Shyang-Rong Shih, PhD 886-2-23123456 ext 61613 firstname.lastname@example.org|
|Principal Investigator: Shyang-Rong Shih, PhD|