Peripheral Arterial DiseaseNCT06436001
Comparing BlueDop Vascular Expert to Ankle-Brachial Index in the Identification of Peripheral Vascular Disease
An observational study of Peripheral Arterial Disease and Diabetes Mellitus, run by Dakota Vascular at 1 site in United States.
Trial summary
To compare the screening capabilities of the BlueDop Vascular Expert (BVE) and ankle brachial index (ABI) in peripheral arterial disease for all-comer patients and those with diagnosed diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease, Diabetes Mellitus
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This retrospective and prospective single-center study to compare the accuracy and screening capabilities of BVE and ABI with that of conventional Full Leg Arterial Duplex (FLAD) was performed at a private clinic in Sioux Falls, South Dakota, USA, with data collected from March 2023 to March 2024.
Who may be able to join
- Patients 18 years or older who presented to the center were consented to have BVE, ABI, and FLAD performed.
Who cannot join
- Patients were excluded who had incomplete or inadequate data, if they were known to be currently pregnant, or if they had contraindications to Doppler ultrasound.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing BlueDop Vascular Expert to Ankle-Brachial Index in the Identification of Peripheral Vascular Disease in All-comers and Diabetic Patients
To compare the screening capabilities of the BlueDop Vascular Expert (BVE) and ankle brachial index (ABI) in peripheral arterial disease for all-comer patients and those with diagnosed diabetes mellitus.
Read the detailed description
This retrospective and prospective single-center study to compare the accuracy and screening capabilities of BVE and ABI with that of conventional Full Leg Arterial Duplex (FLAD) was performed at a private clinic in Sioux Falls, South Dakota, USA, with data collected from March 2023 to March 2024. Currently, BVE carries the European CE Mark but does not yet have FDA approval for use in the United States. This study was undertaken with local IRB approval.
Patients 18 years or older who presented to the center were consented to have BVE, ABI, and FLAD performed. BVE examination of lower extremity arteries were performed following the instruction for use (IFU). All examinations were performed by the same two registered vascular technologists. FLAD ultrasound was carried out with waveform interpretation interpreted by an outside cardiothoracic surgeon who specializes in treatment of arterial disease to determine the presence or absence of disease.
- Conditions
- Peripheral Arterial Disease, Diabetes Mellitus
- Keywords
- peripheral arterial disease, ankle brachial index, arterial duplex, Doppler waveform
- Medical subject headings
- Peripheral Arterial Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BlueDop Vascular Expert | BlueDop Vascular Expert assessment vs Full Leg Arterial Duplex | |
| Ankle Brachial Index | ABI assessment verses Full Leg Arterial Duplex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Comparing ABI and BVE findings to FLAD
Measured: data collected from March 2023 to March 2024
Specificity
Comparing ABI and BVE findings to FLAD
Measured: data collected from March 2023 to March 2024
Accuracy
Comparing ABI and BVE findings to FLAD
Measured: data collected from March 2023 to March 2024
Cohen's Kappa coefficient
Comparing ABI and BVE findings to FLAD
Measured: data collected from March 2023 to March 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Mar 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dakota Vascular
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436001
- Sponsor's protocol ID
- BlueDop_DakotaVascular study
- Other IDs
- CIRBI Link: CR00555039
- Status last verified
- May 2024
- First submitted
- 24 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing BlueDop Vascular Expert to Ankle-Brachial Index in the Identification of Peripheral Vascular Disease in All-comers and Diabetic Patients
- ClinicalTrials.gov ID
- NCT06436001
- Acronym / sponsor ID
- BlueDop_DakotaVascular study
- Conditions
- Peripheral Arterial Disease, Diabetes Mellitus
- Keywords
- peripheral arterial disease, ankle brachial index, arterial duplex, Doppler waveform
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Dakota VascularUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 30 May 2024 (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.
To compare the screening capabilities of the BlueDop Vascular Expert (BVE) and ankle brachial index (ABI) in peripheral arterial disease for all-comer patients and those with diagnosed diabetes mellitus.
Detailed description
This retrospective and prospective single-center study to compare the accuracy and screening capabilities of BVE and ABI with that of conventional Full Leg Arterial Duplex (FLAD) was performed at a private clinic in Sioux Falls, South Dakota, USA, with data collected from March 2023 to March 2024. Currently, BVE carries the European CE Mark but does not yet have FDA approval for use in the United States. This study was undertaken with local IRB approval.
Patients 18 years or older who presented to the center were consented to have BVE, ABI, and FLAD performed. BVE examination of lower extremity arteries were performed following the instruction for use (IFU). All examinations were performed by the same two registered vascular technologists. FLAD ultrasound was carried out with waveform interpretation interpreted by an outside cardiothoracic surgeon who specializes in treatment of arterial disease to determine the presence or absence of disease.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BlueDop Vascular Expert | – | –BlueDop Vascular Expert assessment vs Full Leg Arterial Duplex |
| Ankle Brachial Index | – | –ABI assessment verses Full Leg Arterial Duplex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective and prospective single-center study to compare the accuracy and screening capabilities of BVE and ABI with that of conventional Full Leg Arterial Duplex (FLAD) was performed at a private clinic in Sioux Falls, South Dakota, USA, with data collected from March 2023 to March 2024.
Key inclusion criteria (1 listed)
- Patients 18 years or older who presented to the center were consented to have BVE, ABI, and FLAD performed.
Key exclusion criteria (1 listed)
- Patients were excluded who had incomplete or inadequate data, if they were known to be currently pregnant, or if they had contraindications to Doppler ultrasound.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity
Time frame: data collected from March 2023 to March 2024
Comparing ABI and BVE findings to FLAD
Specificity
Time frame: data collected from March 2023 to March 2024
Comparing ABI and BVE findings to FLAD
Accuracy
Time frame: data collected from March 2023 to March 2024
Comparing ABI and BVE findings to FLAD
Cohen's Kappa coefficient
Time frame: data collected from March 2023 to March 2024
Comparing ABI and BVE findings to FLAD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Diabetes Mellitus, run by Dakota Vascular at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Jun 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: data collected from March 2023 to March 2024). The study lists 4 primary outcomes in all. 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 3 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.