The Application of Digital Infrared Thermal Imaging in Peripheral Artery Disease of the Lower Extremities

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02783677
Collaborator
(none)
230
1
95
2.4

Study Details

Study Description

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 Phase
  • Procedure: Percutaneous balloon angioplasty

Study Design

Study Type:
Observational
Anticipated 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 :
Jan 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Digital infrared thermal imaging (DITI) [7 days]

    Digital infrared thermal imaging (DITI) to detect surface temperature

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei, Taiwan Taipei Taiwan

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT02783677
Other Study ID Numbers:
  • 201209053RIC
First Posted:
May 26, 2016
Last Update Posted:
Feb 6, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 6, 2017