Diabetic foot ulcer
Conditions
Interventions
test group:investigational product
control group:placebo
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent; 2. Age 18-75 years, regardless of gender; 3. The patient has type 1 or type 2 diabetes and is clinically diagnosed with diabetic foot ulcer with at least one skin ulcer deep under the skin or deeper below the ankle joint; 4. The target ulcer lasted for at least 4 weeks before enrollment; If there are multiple lesions, the ulcer with the longest duration and the largest area below the ankle joint should be selected as the target ulcer. 5. Ulcer wounds can be measured, 1 cm2 = 0.4 on the test side; 8. Male subjects shall take effective contraceptive measures within 3 months from the signing of informed consent to the last medication, and shall not donate sperm during this period; Women of childbearing age must have negative serum pregnancy test results at the time of screening and must agree to use effective contraceptive measures from the time of signing the informed consent until 3 months after the last medication; 9. Good compliance, willing and able to follow the treatment and visit prescribed in the study protocol.
Exclusion criteria
Exclusion criteria: 1. Skin ulcers caused by electrical, chemical, radioactive and other reasons, paraplegia; 2. X-ray plain film detection of patients with osteomyelitis; 3. Patients with sinus tract formation on wound surface and other lesions and unable to perform debridement; 4. Ulcer site cancer; 5. Patients with severe hypertension that cannot be controlled after drug treatment: systolic blood pressure >= 160mmHg or diastolic blood pressure >= 100mmHg; 6. The investigator judged that hypoglycemia may occur during the study that would endanger the safety of the subjects; 7. Patients with serious abnormalities in cardiac function, liver function, kidney function and laboratory indicators meet any of the following criteria: (1) NYHA cardiac function grade >= 3 within 6 months before enrollment; (2) The laboratory test values within 7 days before enrollment meet any of the following: 1) ALT > 2.5 x ULN, AST > 2.5 x ULN; 2) Cr > 1.5 x ULN; 3) Hemoglobin < 90 g/L; 4) Albumin < 30 g/L or total protein < 65 g/L; 8. Have malignant tumor or suspected malignant tumor within 5 years prior to screening; 9. Connective tissue diseases, including lupus erythematosus, rheumatoid arthritis, scleroderma, etc. 10. Allergic to any ingredient in the test drug; 11. Participants in clinical trials of other new drugs or medical devices within 3 months prior to screening; 12. Unable to complete the investigator according to the clinical trial protocol due to severe mental or language impairment; 13. The investigator identified patients with grade 2-4 diabetic foot infection according to IWGDF/DISA (2019 edition) criteria; 14. Positive for human immunodeficiency virus antibody, or hepatitis B surface antigen and/or HBV DNA, or hepatitis C virus antibody, or syphilis spiral antibody; 15. The investigator considered that patients, for other reasons, should not participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| validity;Single and multiple pharmacokinetic characteristics; | — |
Countries
China
Contacts
Public ContactYang Jinkui
Department of Endocrinology, Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed