Chronic venous insufficiency ulcer of lower extremity
Conditions
Interventions
Experimental group:Take pentoxifylline sustained-release tablets
Control group:Take pentoxifylline placebo tablets
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >= 18 years; 2.Patients with chronic venous insufficiency of the lower extremity diagnosed as C6 (ulcer 1cm^2 = 0.7; 5.Informed consent signed by the patient or his/her family.
Exclusion criteria
Exclusion criteria: 1.Target ulcers of non-venous etiology (e.g., sickle cell anemia, diabetes, progressive lipid necrosis, pyoderma gangrena, atherosclerotic occlusive vascular disease or vasculitis of the lower extremities); 2.Malignant tumors and immune deficiency diseases under treatment; 3.The presence of severe infections requiring immediate treatment; 4.Pregnant or lactating women, or women of childbearing age who do not take contraceptive measures and plan to become pregnant; 5.Allergic to pentoxifylline or methyl xanthine; 6.Severe infection or gangrenous ulcer; 7.Lower limb edema caused by cardiogenic, hepatogenic, nephrogenic and other reasons; 8.Patients with serious primary diseases of heart, liver, kidney and hematopoietic system, among which ALT >= 2.5 times the upper limit of normal value, AST >= 2.5 times the upper limit of normal value, AND CRE >= 1.5 times the upper limit of normal value; 9.Patients with acute myocardial infarction, severe coronary artery disease, cerebrovascular sclerosis, hypertension or severe arrhythmia; 10.Patients with cerebral hemorrhage, subarachnoid hemorrhage, retinal hemorrhage, hemorrhagic cerebral infarction, or patients with bleeding tendency (such as long-term use of anticoagulants) and recent history of bleeding; 11.The investigator considers that the subjects are not suitable to participate in this study because of potential risks or any other factors that interfere with the subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of ulcer complete healing during treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Target ulcer area reduction rate;Tumor necrosis factor a, interleukin 6;Venous clinical severity score;Comparison of ulcer healing time;Comparison of recurrence rate of cured ulcer between the two groups ;Score of chronic venous insufficiency questionnaire; | — |
Countries
China
Contacts
Public ContactRan Xingwu
West China Hospital of Sichuan University
Outcome results
None listed