Diabetic foot ulcer
Conditions
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-80 years, male or female; 2. Patients who meet the WHO (2019) diagnostic criteria for type 2 diabetes mellitus; 3. Subjects with Wagner grade 2-3 of diabetic foot; 4. Subjects with at least one subcutaneous foot ulcer as target ulcer; 5. Subjects with target ulcer surface area >= 2cm2 and 0.6 on the side of target ulcer; 8. Subjects who signed informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Patients with non-diabetic ulcer, such as rheumatic ulcer, radiation ulcer and vasculitis; 2. The number of ulcer wounds was more than 3 or the surface area of any ulcer wound was more than 10 cm2; 3. Patients with diabetic foot amputated stump wound as target ulcer wound only; 4. The target ulcer is located at the sole of the foot, and can not avoid being squeezed on the ground; 5. Patients with albumin = 2uln; New York Heart function grade IV; SCR >= 1.5uln); hemoglobin < 90g / L); 9. Subjects with mental disorders; 10. Pregnant, planned pregnant and lactating women; 11. Subjects with allergic constitution or known to be allergic to the components contained in the study drug; 12. Screening of patients who had been treated with EGF within 3 months before examination; 13. Screening of patients who had used traditional Chinese medicine or Chinese patent medicine in the treatment of diabetic foot within 2 days before examination (such as Mailuoning oral liquid, Longxuejie capsule, Tongxinluo capsule, Kangfuxin Liquid, etc.), whose main functions include: promoting muscle growth, anti-inflammatory, activating blood circulation and removing blood stasis, promoting granulation and epithelial tissue growth, etc.); 14. Screening of subjects who had participated in other clinical studies within 3 months before the examination; 15. Patients who are not suitable for this study according to the researcher's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surface area of ulcer; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surface area of ulcer;Time to complete re epithelialization of target ulcer wounds;Diabetic foot recovery;Surface area of ulcer;Surface area of ulcer;Rest pain scores;BWAT wound scoring;CRP, ESR, IL-1, IL-6, TNF-a; | — |
Countries
China
Contacts
Public ContactMo Zhaohui
Xiangya Third Hospital of Central South University
Outcome results
None listed