Diabetic foot ulcers
Conditions
Interventions
Control group:Three yellow pearl paste
Sponsors
Tongzhou Branch of Dongzhimen Hospital of 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, consultation with a history of type 2 diabetes, or initial diagnosis of type 2 diabetes patients, glycosylated hemoglobin (HbA1c< 10.0%) during screening; (3) The time of ulceration in the foot = 28 days, and the wound area of the ulcer after debridement is 1cm2 = during screening=25cm2 (if there are multiple lesions, choose below the ankle, the largest ulcer area as the target lesion, and the target lesion is =2cm from other wounds); (4) 0.7= ankle/brachial index (ABI) = 1.3 on the target lesion side; (5) Ulcer conditions are graded 1-2 according to Wagner and = grade 2 according to the International Working Group on Diabetic Foot (IWGDF) standards for mild infection of diabetic foot.
Exclusion criteria
Exclusion criteria: (1) There are gangrene, suppuration or sinus tracts that cannot be removed by debridement; or ulcers with suspected malignant lesions; or foot ulcers that may be caused by other factors (such as electrical, chemical, radioactive, rheumatoid arthritis, tumors, tuberculosis and other endemic ulcers, etc.); Patients with concomitant osteomyelitis; bones, muscles, ligaments, or tendons have been exposed; Patients with peripheral neuropathy such as vascular peripheral neuritis, sciatica, polymyositis, and myasthenia gravis; (2) Within 4 weeks before randomization, undergoing revascularization surgery aimed at increasing blood flow to treat the target limb; or receiving immunosuppressants, chemotherapeutic drugs, radiation therapy, or systemic corticosteroids; Patients with topical medications (including but not limited to growth factors, engineered tissues or skin substitutes) for diabetic foot ulcer indications; (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; (5) Liver function (ALT/AST/TBil) exceeds the upper limit of normal value by 2 times, and renal function Cr exceeds the upper limit of normal value by 2 times; or platelets below the lower limit of normal values; or leukocyte < 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) The surface area of the target lesion ulcer is reduced by = 30% or increased by 50% = during the introduction period of 1 week; (8) Cellulitis or abscess of the target ulcerated foot; (9) Lactating, pregnant women, or patients who are preparing to become pregnant within half a year; (10) Those who have a history of drug allergies, or allergic constitutions (those who are allergic to more than 2 types of substances); (11) Those who have participated in other clinical trials within 3 months; (12) Those who have situations that the researcher deems inappropriate to participate in the research, such as long-term alcohol dependence or drug abuse problems.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in target ulcer area from baseline;The proportion of subjects in which the target ulcer heals completely and the area is reduced = 50%.;The median time for the target ulcer to reach full healing;Proportion of antimicrobials used and duration of use;Changes in TCM syndrome scores;Wangner scored;IWGDF/IDSA grading for diabetic foot infection;Texas rating;WIFI wound size;Grade of degree of ischemia;Inflammation-related tests; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of cases of surgical events received during treatment;Proportion of patients who quit early due to poor efficacy or due to adverse events;Direct treatment costs; | — |
Countries
China
Contacts
Public ContactLi Youshan
Tongzhou Branch of Dongzhimen Hospital of Beijing University of Chinese Medicine
Outcome results
None listed