Pressure ulcers
Conditions
Interventions
Experimental group:tri-yellow pearl paste
Sponsors
Department of Peripheral Blood Vessels, Dongzhimen Hospital Tongzhou Branch, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Know the basic information of clinical research and sign the informed consent form in writing (2) Age 18-75 years old, inpatient or outpatient; (3) Pressure ulcer graded as stage II.-III.; (4) The total area of the 1cm2 = wound is = 100cm2, if there are multiple wounds, the largest wound is selected as the target wound.
Exclusion criteria
Exclusion criteria: (1) There are gangrene suppuration or sinus tracts that cannot be removed by debridement, or ulcers suspected of malignant lesions or pressure ulcers (such as electrochemical radiation rheumatoid arthritis tumor tuberculosis and other endemic ulcers, etc.) that can be caused by other factors and have osteomyelitis; bones, muscles, ligaments, or tendons have been exposed; Patients with peripheral neuropathy such as vascular peripheral neuritis, sciatica, polymyositis, and myasthenia gravis; Cellulitis or abscess of the target ulcer; (2) Received immunosuppressants, chemotherapeutic drugs, radiation therapy or systemic corticosteroids within 4 weeks before randomization; Patients with topical medications (including but not limited to growth factors, engineered tissues or skin substitutes) for indications for pressure ulcers; (3) Have diseases that affect wound healing, such as hemoglobin< 90g/L; or albumin less than 30 g/L; or aplastic anemia, liver disease, scleroderma, etc.; (4) The patient has severe hypertension (systolic blood pressure= 180 mmHg or diastolic blood pressure =110 mmHg); or have had a malignant tumor or suspected malignancy; or a significant history of acute cardiovascular and cerebrovascular disease attacks within 3 months prior to the start of the study, such as acute myocardial infarction, severe angina, acute stroke or transient ischemic attacks; or bleeding disorders and bleeding tendencies; Patients with cognitive impairment; Diabetics; (5) Liver function (ALT/AST/TBil) exceeds the upper limit of normal value by 1.5 times, and renal function Cr exceeds the upper limit of normal value by 1.2 times; or platelets are lower than the lower limit of normal value; or white blood cell < 3.0×109/L. (6) Within 6 months before screening, acute complications of diabetes mellitus occurred, such as diabetic ketoacidosis or lactic acidosis, or hypertonic hyperglycemia syndrome or diabetic hyperosmolar coma; (7) Lactating, pregnant women, or patients who are preparing to become pregnant within half a year; (8) Those with a history of drug allergies, or allergic constitutions (those who are allergic to more than 2 types of substances); (9) Those who have situations that the researcher deems unsuitable to participate in the research, such as long-term alcohol dependence or drug abuse problems.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in TCM syndrome scores;Wound pain VAS score;Proportion of subjects using antibacterial drugs;Changes in the pressure ulcer healing scale;The area of the target ulcer changes from baseline and percentage;The median time for the target ulcer to reach full healing;The length of time that subjects used antimicrobials;Changes in inflammatory-related testing metrics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Direct treatment costs;Proportion of patients who quit as a percentage of total participants; | — |
Countries
China
Contacts
Public ContactLi Youshan
Outcome results
None listed