Saphenous Vein InjuryNCT05099861
Clinical Anatomy of Superficial Veins of Lower Limbs
An observational study of Saphenous Vein Injury, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
The study is focused on clinical anatomy of superficial veins of lower limbs. We are mapping their anatomy via ultrasonography. We are focusing on saphenopopliteal junction and communicants between small saphenous vein and great saphenous vein. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Saphenous Vein Injury
- How many people
- 400 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2021to Aug 2023
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: European population
Who may be able to join
- women and men
- age 18-80
Who cannot join
- wounds on lower limbs
Trial locations and contacts
1 site in 1 country.
About this study
The study is focused on clinical anatomy of superficial veins of lower limbs. We are mapping their anatomy via ultrasonography. We are focusing on saphenopopliteal junction and communicants between small saphenous vein and great saphenous vein.
Read the detailed description
Research project is focused on superficial veins of lower extremities, especially their clinical anatomy. Superficial veins are located within the compartimentum saphenum. The function of superficial veins is drainage of intradermal and epifascial spaces. Superficial veins and their function are fundamental in development of chronic venous disorder. These veins are physiologically connected with deep venous system via perforators but also between each other via communicanting veins. Communicanting veins between small saphenous vein and great saphenous vein have not been described yet, particularly because of their variations. Clinically important is also the saphenopopliteal junction in the fossa poplitea. This region features many variations, which were described in many studies. Also, the nomenclature of saphenopopliteal juction is not standardised in comparison to the saphenofemoral junction. Moreover, many articles are pointing out that there were not specified all potential drainage ways of the cranial extension of small saphenous vein (extesio cranialis). Articles are uniform neither in its prevalence nor in its terminology.
The knowledge of connections between the superficial and deep venous systems as well as knowledge of communicanting veins between superficial veins is important for diagnosis and proper treatment of chronic venous disorder. Variabilities of these veins can play fundamental role in choosing the proper graft for aorto-coronary bypass grafting. The ununiformed nomenclature of superficial veins, their communicating veins and junctions can cause misleading preoperative diagnosis and overlooking of these structures in clinical practise.
- Conditions
- Saphenous Vein Injury
- Being tested
- No intervention
- Keywords
- small saphenous vein, great saphenous vein, saphenopopliteal junction, venae intersaphenae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
this is an observational study
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Healthy volunteers with no sign of internal disease. Age 18-50, both women and men. Receives: Other: No intervention | |
| patients with internal disease | Patients with internal disease, both women and men. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Anatomy of superficial Veins of Lower Limbs
the anatomy observed by ultrasonography imaging focus on communicans between small saphenous vein and great saphenous vein
Measured: 2022-2024
Secondary outcomes (1)
The Anatomy of Superficial Veins of Lower Limbs: junction saphenopopliteal
clinical anatomy of saphenopopliteal junction and its variations observed by ultrasound imaging
Measured: 2022-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start1 Nov 2021
- Primary completion30 Oct 2022
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Saphenous Vein InjuryStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MUDr. Michaela Hronova, Charles University, Czech Republic
- Investigators
- Michaela Hronová, doctor, Principal investigator, 1. faculty of Medicine, Charles University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099861
- Sponsor's protocol ID
- CHU185797621
- Status last verified
- Feb 2023
- First submitted
- 18 Oct 2021
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Anatomy of Superficial Veins of Lower Limbs
- ClinicalTrials.gov ID
- NCT05099861
- Acronym / sponsor ID
- CHU185797621
- Conditions
- Saphenous Vein Injury
- Keywords
- small saphenous vein, great saphenous vein, saphenopopliteal junction, venae intersaphenae
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- Aug 2023 (estimated)
- First posted
- 29 Oct 2021 (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.
The study is focused on clinical anatomy of superficial veins of lower limbs. We are mapping their anatomy via ultrasonography. We are focusing on saphenopopliteal junction and communicants between small saphenous vein and great saphenous vein.
Detailed description
Research project is focused on superficial veins of lower extremities, especially their clinical anatomy. Superficial veins are located within the compartimentum saphenum. The function of superficial veins is drainage of intradermal and epifascial spaces. Superficial veins and their function are fundamental in development of chronic venous disorder. These veins are physiologically connected with deep venous system via perforators but also between each other via communicanting veins. Communicanting veins between small saphenous vein and great saphenous vein have not been described yet, particularly because of their variations. Clinically important is also the saphenopopliteal junction in the fossa poplitea. This region features many variations, which were described in many studies. Also, the nomenclature of saphenopopliteal juction is not standardised in comparison to the saphenofemoral junction. Moreover, many articles are pointing out that there were not specified all potential drainage ways of the cranial extension of small saphenous vein (extesio cranialis). Articles are uniform neither in its prevalence nor in its terminology.
The knowledge of connections between the superficial and deep venous systems as well as knowledge of communicanting veins between superficial veins is important for diagnosis and proper treatment of chronic venous disorder. Variabilities of these veins can play fundamental role in choosing the proper graft for aorto-coronary bypass grafting. The ununiformed nomenclature of superficial veins, their communicating veins and junctions can cause misleading preoperative diagnosis and overlooking of these structures in clinical practise.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | Other: No interventionHealthy volunteers with no sign of internal disease. Age 18-50, both women and men. |
| patients with internal disease | – | Other: No interventionPatients with internal disease, both women and men. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- European population
Key inclusion criteria (2 listed)
- women and men
- age 18-80
Key exclusion criteria (1 listed)
- wounds on lower limbs
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 |
|---|---|---|
| No interventionthis is an observational study | Other | healthy volunteers, patients with internal disease |
Primary outcome
The Anatomy of superficial Veins of Lower Limbs
Time frame: 2022-2024
the anatomy observed by ultrasonography imaging focus on communicans between small saphenous vein and great saphenous vein
1 secondary outcome
The Anatomy of Superficial Veins of Lower Limbs: junction saphenopopliteal
Time frame: 2022-2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- 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. This study is not recruiting at the moment.
Michaela Hronová, doctor principal investigator
1. faculty of Medicine, Charles University
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 Saphenous Vein Injury, run by Charles University, Czech Republic at 1 site in Czechia.
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 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: status not confirmed, as of the sponsor's last update on 13 Feb 2023. 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 Czechia. 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?
Results are not available in the source record.
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?
The Anatomy of superficial Veins of Lower Limbs (time frame: 2022-2024). 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 13 Feb 2023.