Diabetic Foot
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients who meet the diagnostic criteria for diabetes and diabetic foot ulcers in Western medicine and are in the TCM "skin growth phase" (characterized by wounds that are pink or bright red in color, with fresh, fine granulation tissue almost fully covering the wound surface, no exudate, minimal to no obvious drainage, visible wound contraction, epithelial crawling at the edges, or hyperkeratosis at the wound margins); (2) Diabetic foot ulcers (DFUs) classified as Wagner grade 2-3; (3) Wound area of DFUs after debridement is 1-25 cm^2; (4) DFUs have been present for at least 2 weeks; (5) 6% 18 years, regardless of gender; (7) Patients have signed the informed consent form and voluntarily participate in this study.
Exclusion criteria
Exclusion criteria: (1) Patients who have developed severe ischemia with local gangrene requiring amputation; those with dry gangrene at admission; (2) Patients with genetic, contagious diseases, malignant tumors, or severe malnutrition; (3) Patients with severe dysfunction of the heart, liver, or kidneys and uncorrected systemic infections; (4) Women who are pregnant or breastfeeding; (5) Patients with severe malnutrition, mental disorders, alcoholism, or drug addiction; (6) Patients who have participated in other clinical trials within the past 4 weeks. (7) Patients whose ulcer area has decreased by more than 30% from the screening visit to the baseline visit (approximately 1 week).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound healing ratio;Fasting blood glucose;Hemoglobin A1c;IL-1ß;IL-4;TNF-a;IL-6;IL-10; | — |
Countries
China
Contacts
Foshan Hospital of Traditional Chinese Medicine