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Development of lower extremity deep venous valve functional assessment method and the artificial valves based on multi-parameter integration

Development of lower extremity deep venous valve functional assessment method and the artificial valves based on multi-parameter integration

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500106957
Enrollment
Unknown
Registered
2025-07-31
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Venous Insufficiency

Interventions

DVI:Clinical assessment, imaging examination, and functional parameter collection.
Control:Clinical assessment, imaging examination, and functional parameter collection.

Sponsors

Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria for Patients: 1. Aged between 18 and 75 years, with normal function of major organs; 2. Classified as any clinical category C0 to C6 according to the CEAP classification, and diagnosed with primary venous insufficiency; 3. Diagnosed with chronic venous disease of the lower limbs by color Doppler ultrasound and venography. Inclusion Criteria for Healthy Controls: 1. Aged between 18 and 75 years, with normal function of major organs; 2. No subjective symptoms such as heaviness or soreness in the lower limbs; 3. No clinical signs of varicose veins, skin pigmentation, or ulcers in the lower limbs; 4. Color Doppler ultrasound examination of the lower limb veins (including deep, superficial, and perforating veins) shows no abnormalities in patency or reflux.

Exclusion criteria

Exclusion criteria: 1. Individuals with venous obstruction or post-thrombotic syndrome (PTS); 2. Individuals with a history of lower limb venous surgery; 3. Individuals with concomitant peripheral arterial disease (defined as an ankle-brachial index < 0.9); 4. Individuals with a history of systemic diseases such as angina, myocardial infarction, asthma, chronic obstructive pulmonary disease (COPD), chronic heart failure, liver failure, renal failure, or malignancy; 5. Individuals who are pregnant or planning to become pregnant; 6. Individuals with a history of musculoskeletal degenerative diseases; 7. Individuals unable to tolerate intravenous cannulation or unable to follow instructions to complete physical movements.

Design outcomes

Primary

MeasureTime frame
venous structural and functional parameters;hemodynamic parameters;proteomic indicators;

Secondary

MeasureTime frame
medical history and demographic characteristics;lifestyle and exposure history;

Countries

China

Contacts

Public ContactYifei Hu

China Capital Medical University

huyifei@yahoo.com+86 10 8391 1747

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026