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Clinical Trials/NCT02783677
NCT02783677
Unknown
Not Applicable

The Application of Digital Infrared Thermal Imaging in Peripheral Artery Disease

National Taiwan University Hospital1 site in 1 country230 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Artery Disease
Sponsor
National Taiwan University Hospital
Enrollment
230
Locations
1
Primary Endpoint
Digital infrared thermal imaging (DITI)
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
December 2020
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age: 20\~85 years old
  • Diagnosed with DM

Exclusion Criteria

  • History of lower extremities disease or underwent leg surgery
  • Pregnancy
  • Leg edema
  • Autoimmune disease

Outcomes

Primary Outcomes

Digital infrared thermal imaging (DITI)

Time Frame: 7 days

Digital infrared thermal imaging (DITI) to detect surface temperature

Study Sites (1)

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