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

NCT ID: NCT02783677

Last Updated: 2017-02-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2020-12-31

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.

Conditions

Peripheral Artery Disease; Diabetes Mellitus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

DM with PAD before angioplasty

Diabetic patients diagnosed with peripheral artery disease via vascular Duplex.

No interventions assigned to this group

DM without PAD

Diabetic patients diagnosed without peripheral artery disease via vascular Duplex.

No interventions assigned to this group

Healthy volunteers

Healthy volunteers

No interventions assigned to this group

DM with PAD after angioplasty

Diabetic patients diagnosed with PAD underwent balloon-angioplasty

Percutaneous balloon angioplasty

Intervention Type: PROCEDURE

Interventions

Percutaneous balloon angioplasty

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital Taipei, Taiwan

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Shyang-Rong Shih, PhD

Role: primary

srshih@ntu.edu.tw

886-2-23123456 ext. 61613

Other Identifiers

201209053RIC

Identifier Type: -

Identifier Source: org_study_id