Skip to main content
Clinical Trials/NCT05941533
NCT05941533
Recruiting
Not Applicable

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

Fangge Deng1 site in 1 country50 target enrollmentMarch 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Artery Disease (PAD)
Sponsor
Fangge Deng
Enrollment
50
Locations
1
Primary Endpoint
To determine the validity and reliability of IRTI in assessing foot blood perfusion and surgical success rate after PTA treatment.
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
June 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Fangge Deng
Responsible Party
Sponsor Investigator
Principal Investigator

Fangge Deng

: Principal Investigator

The First Affiliated Hospital of Guangzhou Medical University

Eligibility Criteria

Inclusion Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

Loading locations...

Similar Trials