Diabetic foot ulcers
Conditions
Interventions
A group:Test drug treatment once daily
B group:The test drug was administered once every other day
C group:Placebo treatment once daily
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent (ICF); 2. Age>=18 years, gender is not limited; 3. The patient has type 1 or type 2 diabetes mellitus, clinically diagnosed diabetic foot, and has at least one skin ulcer below the ankle joint; 4. Target ulcer persistent for at least 2 weeks prior to enrollment; If there are multiple lesions and ulcers, the ulcer below the ankle joint with a high Wagner grade and a large area is selected as the target ulcer; 5. At screening and randomization, the target ulcer wound area of 2cm^2 =0.6 and < 1.3; 8. At screening, the investigator judged to be level 3 or below according to the IWGDF/IDSA (2023 edition) grading criteria; 9. At the time of screening, the investigator judged it to be grade 2-3 according to the Wagner grading criteria, but patients with osteomyelitis (those who have been cured or controlled by the investigator can be enrolled) [those who have amputated the toe end for various reasons before screening (including those caused by diabetic foot in the past), and those who have completely healed at the time of screening can be enrolled]; 10. Male subjects agree to take effective contraceptive measures from signing the informed consent form to 3 months after the last dose, and are not allowed to donate sperm during this period; Females of childbearing potential must have a negative serum pregnancy test result at screening and must agree to use effective contraception from the time of signing the informed consent form until 3 months after the last dose; 11. Good compliance, willing and able to follow the treatment and visits specified in the study protocol;
Exclusion criteria
Exclusion criteria: 1.Pregnant or postmenstrual women or women of childbearing age with a positive pregnancy test; 2.Those who are allergic to the test drug or its components; 3.Non-diabetic foot ulcers, such as those caused by electrical, chemical, radioactive or other causes; 4.Acute Chalky neuropathic arthropathy was clinically (or radiologically) diagnosed; 5.The researchers judged that the ulcer wound was a sinus tract or that the debridement could not be performed for other reasons; 6.The researchers judged the suspected cancerous ulcer site according to the ulcer wound condition; 7.Severe hypertension that cannot be controlled by medication: systolic blood pressure >= 160mmHg or diastolic blood pressure >= 100mmHg; 8.Patients who underwent lower extremity blood revascularization or angioplasty (including interventional therapy, surgical treatment, etc.) within the first 2 weeks of randomization or who may need blood revascularization or angioplasty during the study period; 9.During screening, acute diabetic complications occurred, such as grade 3 hypoglycemia, diabetic ketoacidosis, hyperosmolar hyperglycemic state, etc; 10.History of myocardial infarction, unstable angina, coronary artery revascularization, stroke, and heart failure NYHA class III-IV within the first 6 months of randomization; 11.During screening, those with severe liver function, renal function or laboratory abnormalities: ALT> 2.5 times ULN or AST> 2.5 times ULN or TBIL> 1.5 times ULN; Estimated glomerular filtration rate (eGFR, CKD-EPI formula) <30ml/min/1.73m^2 or undergoing renal replacement therapy; Hemoglobin <90g/L; Albumin <30g/L; 12.History of malignant tumor in the last 5 years; 13.During screening, HIV antibody and syphilis spirochete antibody tests were positive; 14.During screening, other skin or systemic diseases that affect the judgment of efficacy and safety were combined; 15.Randomized to receive any of the following drugs or methods for treatment of diabetic foot ulcers within 2 weeks: growth factor therapy/cytokine therapy, stem cell therapy, gene therapy, other debridement treatments other than sharp debridement (such as enzymatic debridement, biological debridement, ultrasonic debridement, water knife debridement, etc.); 16.Randomized to use immunosuppressive agents (including systemic corticosteroids), cytotoxic chemotherapy, cell suppression therapy, autoimmune disease treatment, etc. within 1 month; 17.Other clinical findings in the first 12 months of randomization indicating severe diseases, including but not limited to respiratory, circulatory, digestive, endocrine, rheumatologic and immunological, neurological, hematological diseases and psychiatric/psychological disorders, which the investigator deems unsuitable for participation in this trial; 18.Participants who have participated in clinical trials of other new drugs or medical devices within the previous 3 months (except those who failed screening); 19.The investigator is unable to complete the study according to the clinical trial protocol due to serious mental or language impairment; 20.The researchers considered those who were not compliant with the decompression treatment or other medical instructions, or who were not suitable to participate in this clinical trial for other reasons;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in wound area at the end of week 12 after treatment compared to baseline;The proportion of subjects who achieved complete granulation tissue coverage of the wound within 12 weeks after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| 12 lead electrocardiogram;laboratory examination;Incidence of adverse events;The percentage of subjects who achieved complete granulation tissue coverage at the end of weeks 2, 4, 6, 8, and 10 after treatment;The time it takes for a wound to heal completely;Vital sign;The time required for granulation tissue to completely cover the wound;Incidence of local adverse reactions;The proportion of subjects with complete wound healing;Percentage change in wound area at end of weeks 2, 4, 6, 8, and 10 after treatment compared to baseline;physical examination; | — |
Countries
China
Contacts
Public ContactXingwu Ran
West China Hospital of Sichuan University
Outcome results
None listed