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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
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.


Condition or disease Intervention/treatment
Peripheral Artery Disease Diabetes Mellitus Procedure: Percutaneous balloon angioplasty

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Study Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Healthy volunteers
Healthy volunteers
DM with PAD after angioplasty
Diabetic patients diagnosed with PAD underwent balloon-angioplasty
Procedure: Percutaneous balloon angioplasty



Primary Outcome Measures :
  1. Digital infrared thermal imaging (DITI) [ Time Frame: 7 days ]
    Digital infrared thermal imaging (DITI) to detect surface temperature



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults with DM
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783677


Locations
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Taiwan
National Taiwan University Hospital Taipei, Taiwan Recruiting
Taipei, Taiwan
Contact: Shyang-Rong Shih, PhD    886-2-23123456 ext 61613    srshih@ntu.edu.tw   
Principal Investigator: Shyang-Rong Shih, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02783677    
Other Study ID Numbers: 201209053RIC
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases