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

NCT05941533 | Unknown

• 1 other identifier: IRTIPTA
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease (PAD)

Keywords

peripheral artery disease (PAD), infrared thermal imaging (IRTI), percutaneous transluminal angioplasty (PTA)

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PAD patients who came to our hospital for diagnosis and treatment were initially selected, and those who met the indications for PTA surgery were finally included in the study.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fangge Deng: lead

Study Sites (1)

Fangge Deng

Guangzhou, Guangdong, 510163, China

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: : Principal Investigator

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 12, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

CN (1)