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

• Conditions: Diabetes Mellitus; Peripheral Artery Disease
• Interventions: Procedure: Percutaneous balloon angioplasty

• Registration Number: NCT02783677
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-26
• Status Verified: 2017-01
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-06
• Primary Completion: 2018-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 230

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DM with PAD after angioplasty	Percutaneous balloon angioplasty	Diabetic patients diagnosed with PAD underwent balloon-angioplasty

Primary Outcome Measures

Name	Time	Method
Digital infrared thermal imaging (DITI)	7 days	Digital infrared thermal imaging (DITI) to detect surface temperature

Trial Locations

Locations (1)

National Taiwan University Hospital Taipei, Taiwan; 🇨🇳 Taipei, Taiwan