Infrared Thermal Imaging in Evaluating the Percutaneous Transluminal Angioplasty for Peripheral Artery Disease

Peripheral Artery Disease (PAD) Clinical Trial

Official title:

Infrared Thermal Imaging in Evaluating the Percutaneous Transluminal Angioplasty for Peripheral Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05941533
• Other study ID #: IRTIPTA
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: July 2023
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Determination of IRTI (infrared thermal imaging) can be used to evaluate PAD patients with critical limb ischemia with different degrees of lesion.

IRTI can be used to evaluate the foot blood perfusion after percutaneous transluminal angioplasty (PTA) treatment and determine the success rate of surgery.

IRTI can be used as an effective follow-up tool for patients after surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2024
• Est. primary completion date: March 1, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with Rutherford grade 3, 4, 5, or 6.

• Patients with indications for lower extremity arterial PTA: severe intermittent claudication, rest pain, ulceration or gangrene.

• Patients who required PTA of only one limb (left versus right).

Exclusion Criteria:

• Patients with body temperature above 37 ° C.

• Patients with indications for open surgery.

• Patients requiring major amputation (above the ankle).

• Patients with acute occlusive or embolic limb ischemia.

• Patients with deep venous thrombosis of the lower extremity.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease (PAD)

Locations

Country	Name	City	State
China	Fangge Deng	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fangge Deng

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the validity and reliability of IRTI in assessing foot blood perfusion and surgical success rate after PTA treatment.	The different levels of pseudocodes (white, red, pink, yellow, green, blue, and black) represent the corresponding IRTI, corresponding to the color bar from low to high temperature.; We will measure the average temperature of the dorsum and sole of the foot before and after PTA treatment in the operated and non-operated limbs. Ankle-brachial index (ABI) of the operated and non-operated limbs before and after PTA treatment will also be measured.; We will analyze the agreement between ABI and foot temperature in the operated and non-operated limbs, as well as the agreement between the change in ABI and foot temperature.	up to 15 months