Duplex Ultrasound Versus Conventional Angiography in Evaluating Lower Limb Threatening Ischemia (DUS-CTA)

August 2, 2025 updated by: Baraa Mohmamed Abdelrahman, Sohag University

The Diagnostic Value of Duplex Ultrasound in Evaluating Infra Inguinal Arteries in Patients With Chronic Limb Threatening Ischemia : A Comparative Study With Angiography

This study aims to evaluate the accuracy of Duplex Ultrasound (DUS) in assessing infra inguinal arterial lesions in patients with chronic threatening limb ischemia compared with digital subtraction angiography (DSA) as the reference standard. By comparing sensitivity, specificity, and predictive values across arterial segments, the study seeks to determine the clinical utility of DUS as a non-invasive alternative for pre-intervention vascular mapping in chronic limb-threatening ischemia.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Sohag, Egypt, 82511
        • Sohag University hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- 1. Clinical diagnosis of chronic threatening lower limb ischemia (rest pain, non-healing ulcer, or gangrene).

2. Ability to provide informed consent.

Exclusion Criteria:

  • 1. Hemodynamically unstable patients not fit for angiography. 2. Patients with non-atherosclerotic arterial diseases (e.g., vasculitis, Buerger's disease).

    3. Known contrast allergy or renal insufficiency precluding contrast angiography.

    4. Inadequate acoustic window or inability to undergo complete DUS examination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients with chronic threatening limb ischemia
Duplex Ultrasound (DUS) assessment of infra inguinal arterial lesions in patients with chronic threatening limb ischemia and then compared with digital subtraction angiography (DSA) as the reference standard.
Radiation: conventional angiography
  • Peak systolic velocity (PSV)
  • Velocity ratios
  • Segment visualization quality
  • Degree of stenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of DUS compared to DSA in detecting ≥50% stenosis or occlusion in femoral, popliteal, and infra popliteal arteries.
Time Frame: from enrollment till angioplasty (14 days mostly)
sensitivity, specificity, positive predictive value, negative predictive value
from enrollment till angioplasty (14 days mostly)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 2, 2025

Primary Completion (Estimated)

March 2, 2026

Study Completion (Estimated)

April 2, 2026

Study Registration Dates

First Submitted

August 2, 2025

First Submitted That Met QC Criteria

August 2, 2025

First Posted (Actual)

August 8, 2025

Study Record Updates

Last Update Posted (Actual)

August 8, 2025

Last Update Submitted That Met QC Criteria

August 2, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-25-7-22MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Threatening Lower Limb Ischemia

Clinical Trials on conventional angiography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe