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

Sponsor
Fangge Deng (Other)
Overall Status
Recruiting
CT.gov ID
NCT05941533
Collaborator
(none)
50
Enrollment
1
Location
15
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Mar 1, 2023
    Anticipated Primary Completion Date :
    Mar 1, 2024
    Anticipated Study Completion Date :
    Jun 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Fangge Deng Guangzhou Guangdong China 510163

    Sponsors and Collaborators

    • Fangge Deng

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Jul 12, 2023
    Last Update Posted:
    Jul 18, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fangge Deng, : Principal Investigator, The First Affiliated Hospital of Guangzhou Medical University
    peripheral artery disease (PAD), infrared thermal imaging (IRTI), percutaneous transluminal angioplasty (PTA)
    Additional relevant MeSH terms:
    Peripheral Arterial Disease

    Study Results

    No Results Posted as of Jul 18, 2023