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

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ClinicalTrials.gov Identifier: NCT05941533
Recruitment Status : Recruiting
First Posted : July 12, 2023
Last Update Posted : July 18, 2023
Sponsor:
Information provided by (Responsible Party):
Fangge Deng, The First Affiliated Hospital of Guangzhou Medical University

Study Description
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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.


Condition or disease
Peripheral Artery Disease (PAD)

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Infrared Thermal Imaging in Evaluating the Percutaneous Transluminal Angioplasty for Peripheral Artery Disease
Actual Study Start Date : March 1, 2023
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : June 1, 2024

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. To determine the validity and reliability of IRTI in assessing foot blood perfusion and surgical success rate after PTA treatment. [ Time Frame: 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05941533


Locations
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China, Guangdong
Fangge Deng Recruiting
Guangzhou, Guangdong, China, 510163
Contact: Fangge Deng, Researcher    86 13234006746    fangge256@sina.com   
Sponsors and Collaborators
Fangge Deng
More Information
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Responsible Party: Fangge Deng, : Principal Investigator, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT05941533    
Other Study ID Numbers: IRTIPTA
First Posted: July 12, 2023    Key Record Dates
Last Update Posted: July 18, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fangge Deng, The First Affiliated Hospital of Guangzhou Medical University:
peripheral artery disease (PAD), infrared thermal imaging (IRTI), percutaneous transluminal angioplasty (PTA)
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases