Sohag University Hospital
Sohag, Sohag Governorate, 82511, Egypt
Not Yet Recruiting
NCT Number: NCT07113197
Duplex Ultrasound Versus Conventional Angiography in Evaluating Lower Limb Threatening Ischemia
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
40 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 1. Clinical diagnosis of chronic threatening lower limb ischemia (rest pain, non-healing ulcer, or gangrene).
- 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).
- Known contrast allergy or renal insufficiency precluding contrast angiography.
- Inadequate acoustic window or inability to undergo complete DUS examination.
Treatment and study plan
conventional angiography
Radiation- Peak systolic velocity (PSV)
- Velocity ratios
- Segment visualization quality
- Degree of stenosis
Primary outcomes
-
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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Sohag University
Other
Registry information
Official study title
The Diagnostic Value of Duplex Ultrasound in Evaluating Infra Inguinal Arteries in Patients With Chronic Limb Threatening Ischemia : A Comparative Study With Angiography
Acronym: DUS-CTA
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Aug 8, 2025
- Registry last updated
- Aug 8, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.