Critical Limb IschemiaNCT06191237
Effect of Environmental Temperature on Vascular Ultrasound Vein Scan Measurements
An observational study of Critical Limb Ischemia, run by University Hospital of Limerick.
Trial summary
We wish to conduct two vascular ultrasound scans conducting vein measurements in two separate scanning rooms to assess if environmental temperature affects the vein diameter recorded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Sep 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those who meet inclusion criteria under the care of a Consultant Vascular Surgeon with no varicose veins/venous insufficiency will have vascular ultrasound vein scans performed and measurements recorded.
Who may be able to join
- Inpatient at University Hospital Limerick under the care of a Vascular Consultant
- Aged 18 years and above
- Deemed suitable for two vascular ultrasound scans by the P.I
Who cannot join
- Those unable to give informed consent
- Aged under 18 years
- Patients with varicose veins/venous insufficiency
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
We wish to conduct two vascular ultrasound scans conducting vein measurements in two separate scanning rooms to assess if environmental temperature affects the vein diameter recorded.
Read the detailed description
Vascular surgeons are guided by vascular ultrasound scans when deciding treatment plans for their patients. In critical limb threatening ischaemia with infrainguinal disease, vein bypass has the best limb salvage and long term survival rates in patients who are appropriately selected. In lower limb "vein mapping", the vein is measured to assess suitability for use as a bypass conduit with the favoured bypass conduit being autologous, ipsilateral vein of good quality and length and a size of >3mm is considered a good conduit.
The research team found one study which explored the effect of room temperature on upper limb vein measurements which was conducted in Singapore. This showed an underestimation of vein size at lower temperatures. We wish to add to the literature and irish research by conducting this study at University Hospital Limerick in order to optimise conditions for vascular assessments and therefore facilitate clinical decision making.
We aim to scan and record vein measurements on the lower limbs of vascular inpatients at University Hospital Limerick who are deemed suitable by the P.I.
Patients will have the ultrasound scan completed twice. The first room will have its temperature recorded and the vein measurements taken.
The second room will be set at a higher temperature which we have defined as being 6-10 degrees greater than ambient room temperature. We will achieve this through use of a portable heater.
We will compare the two recordings to assess if there is a difference in the diameter of the vein measured in the warmer room versus the standard room.
The importance of this is to assess the impact of environmental factors on vascular ultrasound scan results, therefore impacting on patient outcomes by use of the most suitable bypass conduit.
- Conditions
- Critical Limb Ischemia
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Vein diameter measurements in two temperature controlled rooms
Two vascular ultrasound scans will be performed on the lower limb. A defined scanning protocol will be adhered to which will ensure consistency and accuracy.
During the course of both ultrasound scans, vein measurements will be taken and recorded on the study sheet which will have the participant study identification number, age and gender.
The second room will be set at a higher temperature which we have defined as being 6-10 degrees greater than ambient room temperature.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona Leahy, University Hospital of Limerick
- Investigators
- Zeeshan Ahmed, FRCS, Principal investigator, Consultant Vascular Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191237
- Sponsor's protocol ID
- DVS009
- Status last verified
- Apr 2025
- First submitted
- 20 Dec 2023
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Environmental Temperature on Vascular Ultrasound Vein Scan Measurements
- ClinicalTrials.gov ID
- NCT06191237
- Acronym / sponsor ID
- DVS009
- Conditions
- Critical Limb Ischemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital of LimerickUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 5 Jan 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.
We wish to conduct two vascular ultrasound scans conducting vein measurements in two separate scanning rooms to assess if environmental temperature affects the vein diameter recorded.
Detailed description
Vascular surgeons are guided by vascular ultrasound scans when deciding treatment plans for their patients. In critical limb threatening ischaemia with infrainguinal disease, vein bypass has the best limb salvage and long term survival rates in patients who are appropriately selected. In lower limb "vein mapping", the vein is measured to assess suitability for use as a bypass conduit with the favoured bypass conduit being autologous, ipsilateral vein of good quality and length and a size of >3mm is considered a good conduit.
The research team found one study which explored the effect of room temperature on upper limb vein measurements which was conducted in Singapore. This showed an underestimation of vein size at lower temperatures. We wish to add to the literature and irish research by conducting this study at University Hospital Limerick in order to optimise conditions for vascular assessments and therefore facilitate clinical decision making.
We aim to scan and record vein measurements on the lower limbs of vascular inpatients at University Hospital Limerick who are deemed suitable by the P.I.
Patients will have the ultrasound scan completed twice. The first room will have its temperature recorded and the vein measurements taken.
The second room will be set at a higher temperature which we have defined as being 6-10 degrees greater than ambient room temperature. We will achieve this through use of a portable heater.
We will compare the two recordings to assess if there is a difference in the diameter of the vein measured in the warmer room versus the standard room.
The importance of this is to assess the impact of environmental factors on vascular ultrasound scan results, therefore impacting on patient outcomes by use of the most suitable bypass conduit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those who meet inclusion criteria under the care of a Consultant Vascular Surgeon with no varicose veins/venous insufficiency will have vascular ultrasound vein scans performed and measurements recorded.
Key inclusion criteria (3 listed)
- Inpatient at University Hospital Limerick under the care of a Vascular Consultant
- Aged 18 years and above
- Deemed suitable for two vascular ultrasound scans by the P.I
Key exclusion criteria (3 listed)
- Those unable to give informed consent
- Aged under 18 years
- Patients with varicose veins/venous insufficiency
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
Vein diameter measurements in two temperature controlled rooms
Time frame: 3 months
Two vascular ultrasound scans will be performed on the lower limb. A defined scanning protocol will be adhered to which will ensure consistency and accuracy. During the course of both ultrasound scans, vein measurements will be taken and recorded on the study sheet which will have the participant study identification number, age and gender. The second room will be set at a higher temperature which we have defined as being 6-10 degrees greater than ambient room temperature.
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 4 May 2025.
- Individual participant dataSharing planned: No
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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.
Zeeshan Ahmed, FRCS principal investigator
Consultant Vascular Surgeon
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Limb Ischemia, run by University Hospital of Limerick.
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 3 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 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Fiona Leahy, MSc (0874525597, fionac.leahy@hse.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vein diameter measurements in two temperature controlled rooms (time frame: 3 months). 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 4 May 2025.