Chronic Threatening Lower Limb IschemiaDUS-CTANCT07113197
Duplex Ultrasound Versus Conventional Angiography in Evaluating Lower Limb Threatening Ischemia
A study testing conventional angiography in people with Chronic Threatening Lower Limb Ischemia, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Threatening Lower Limb Ischemia
- What is being tested?
- conventional angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Sep 2025to 2 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Clinical diagnosis of chronic threatening lower limb ischemia (rest pain, non-healing ulcer, or gangrene).
- 2. Ability to provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag University Hospital
Sohag, Sohag Governorate, 82511
Baraa Mohammad Abd elrahman, Bachelor's degree, +20 01012121608, hicaptain046@gmail.com
About this study
Official title: 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.
- Conditions
- Chronic Threatening Lower Limb Ischemia
- Being tested
- conventional angiography
- Keywords
- Duplex, Angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional angiographyRadiation
- Peak systolic velocity (PSV)
- Velocity ratios
- Segment visualization quality
- Degree of stenosis
| Study group | Role | What they receive |
|---|---|---|
| patients with chronic threatening limb ischemia | Experimental | 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. Receives: Radiation: conventional angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of DUS compared to DSA in detecting ≥50% stenosis or occlusion in femoral, popliteal, and infra popliteal arteries.
sensitivity, specificity, positive predictive value, negative predictive value
Measured: from enrollment till angioplasty (14 days mostly)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start2 Sep 2025 (estimated)
- Primary completion2 Mar 2026 (estimated)
- Study completion2 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Threatening Lower Limb IschemiaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baraa Mohmamed Abdelrahman, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113197
- Sponsor's protocol ID
- Soh-Med-25-7-22MS
- Acronym
- DUS-CTA
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value of Duplex Ultrasound in Evaluating Infra Inguinal Arteries in Patients With Chronic Limb Threatening Ischemia : A Comparative Study With Angiography
- ClinicalTrials.gov ID
- NCT07113197
- Acronym / sponsor ID
- DUS-CTA / Soh-Med-25-7-22MS
- Conditions
- Chronic Threatening Lower Limb Ischemia
- Keywords
- Duplex, Angiography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 2 Sep 2025 (estimated)
- Primary completion
- 2 Mar 2026 (estimated)
- Study completion
- 2 Apr 2026 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with chronic threatening limb ischemia | Experimental | Radiation: conventional angiographyDuplex 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Clinical diagnosis of chronic threatening lower limb ischemia (rest pain, non-healing ulcer, or gangrene).
- 2. Ability to provide informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional angiography* Peak systolic velocity (PSV) * Velocity ratios * Segment visualization quality * Degree of stenosis | Radiation | patients with chronic threatening limb ischemia |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional angiography in people with Chronic Threatening Lower Limb Ischemia, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Baraa Mohammad Abd elrahman, Bachelor degree (+20 01012121608, baraa_mohamed_post@med.sohag), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.