venous ulceration of lower extremity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Clinical diagnosis of venous leg ulcer (CEAP classification C5 or C6), with chronic venous insufficiency of the lower extremities (e.g., deep/superficial venous reflux or obstruction) confirmed by color Doppler ultrasound (CDUS); 2.Ulcer duration >= 4 weeks; 3.Ulcer area between 1 and 25 cm^2; 4.Ability to understand and voluntarily sign the informed consent form, and commitment to complete regular follow-up visits; 5. Age >= 18 years old;
Exclusion criteria
Exclusion criteria: 1.Ankle-Brachial Index (ABI) < 0.8, or a clinically confirmed diagnosis of arterial ulcer or mixed ulcer with predominantly arterial etiology; 2.Ulcers resulting from primary non-venous etiologies such as diabetic neuropathy, pressure, trauma, vasculitis, malignancy, or infection; 3.The target ulcer has received specific treatments (e.g., advanced dressings, bioengineered skin, venous surgery, etc.) within 4 weeks prior to enrollment that may interfere with the assessment; 4.Presence of active severe infection (e.g., osteomyelitis) or exposed bone/tendon in the ulcer, requiring priority management; 5.Allergy to ultrasound contrast agents; 6.Presence of severe systemic diseases; 7.Pregnant or breastfeeding women;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Microvascular flow velocity, Blood volume,Perfusion index, Peak intensity, Area under curve (AUC), Arrival time, Time to peak (TTP); | — |
Secondary
| Measure | Time frame |
|---|---|
| CEAP classification; | — |
Countries
China
Contacts
The First Affiliated Hospital of Chongqing Medical University