NCT06175481

Brief Summary

When the liquid flow increases, the luminal caliber's stretching amplitude decreases, leading to a higher hydraulic pressure according to Poiseuille's law. In this study, investigators measured the caliber change of the popliteal vein under a rated pressure gradient and evaluated the relationship between popliteal vein compliance and venous clinical severity score (VCSS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 19, 2023

Completed
Last Updated

December 19, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

November 28, 2023

Last Update Submit

December 17, 2023

Conditions

Chronic Venous Disease (CVD), Vein Compliance, Venous Clinical Severity Score (VCSS)

Outcome Measures

Primary Outcomes (1)

  • Compliance of the popliteal vein

    Compliance of the popliteal vein is calculated as the distensibility, with the ratio of functional caliber/native caliber/cuff pressure value

    May 2023 to October 2023

Study Arms (2)

control group

Other: Popliteal Vein Compliance

experimental group

Other: Popliteal Vein Compliance

Interventions

Popliteal Vein ComplianceOTHER

Compliance of the popliteal vein is calculated as the distensibility, with the ratio of functional caliber/native caliber/cuff pressure value ( mmHg-1 ).

control groupexperimental group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients were prospectively enrolled in Guangdong Second Provincial General Hospital from May 2023 to October 2023. All participants gave their voluntary consent.

You may qualify if:

  • C1 to C6 disease using the CEAP (clinical, etiologic, anatomic, pathophysiologic) classification.

You may not qualify if:

  • acute or chronic thrombosis of deep veins, previously received intravenous surgery or injection sclerotherapy, ankle brachial index\<0.90, and concomitant cardiovascular, pulmonary, renal, or metabolic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hao Liu

Guangzhou, Guangdong, 510317, China

Location

Related Publications (1)

  • Liu H, Li L, Wei W, Tang Y, Liu L, Xiao C. Correlation between popliteal vein functional diameter and the severity of chronic venous disease. Phlebology. 2025 Jul;40(6):415-419. doi: 10.1177/02683555241310531. Epub 2024 Dec 21.

    PMID: 39708049DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 19, 2023

Study Start

June 1, 2023

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

December 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)