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

Recruiting

• Conditions: Peripheral Artery Disease (PAD)

• Registration Number: NCT05941533
• Lead Sponsor: Fangge Deng

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-07-04
• Study First Posted: 2023-07-12
• Last Update Submitted: 2023-07-16
• Last Update Posted: 2023-07-18
• Primary Completion: 2024-03-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the validity and reliability of IRTI in assessing foot blood perfusion and surgical success rate after PTA treatment.	up to 15 months	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.

Trial Locations

Locations (1)

Fangge Deng; 🇨🇳 Guangzhou, Guangdong, China