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Duplex Ultrasound Versus Conventional Angiography in Evaluating Lower Limb Threatening Ischemia

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07113197
Acronym
DUS-CTA
Enrollment
50
Registered
2025-08-08
Start date
2025-09-02
Completion date
2026-04-02
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Threatening Lower Limb Ischemia

Keywords

Duplex, Angiography

Brief summary

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.

Interventions

RADIATIONconventional angiography

* Peak systolic velocity (PSV) * Velocity ratios * Segment visualization quality * Degree of stenosis

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Countries

Egypt

Contacts

Primary ContactBaraa Mohammad Abd elrahman, Bachelor degree
baraa_mohamed_post@med.sohag+20 01012121608

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026