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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

Tracking Information
First Submitted Date April 11, 2016
First Posted Date May 26, 2016
Last Update Posted Date February 6, 2017
Study Start Date January 2013
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 2, 2017)
Digital infrared thermal imaging (DITI) [ Time Frame: 7 days ]
Digital infrared thermal imaging (DITI) to detect surface temperature
Original Primary Outcome Measures
 (submitted: May 24, 2016)
Digital infrared thermal imaging (DITI) [ Time Frame: 7 days ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: May 24, 2016)
ankle-brachial index [ Time Frame: 7 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Application of Digital Infrared Thermal Imaging in Peripheral Artery Disease of the Lower Extremities
Official Title The Application of Digital Infrared Thermal Imaging in Peripheral Artery Disease
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults with DM
Condition
  • Peripheral Artery Disease
  • Diabetes Mellitus
Intervention Procedure: Percutaneous balloon angioplasty
Study Groups/Cohorts
  • 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
    Intervention: Procedure: Percutaneous balloon angioplasty
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 24, 2016)
230
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02783677
Other Study ID Numbers 201209053RIC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account National Taiwan University Hospital
Verification Date January 2017