Diabetic Foot Ulcer
Conditions
Interventions
control group:Internal medicine basic treatment combined with surgical basic treatment
experimental group:On the basis of the control group add Danzhi Jiangtang capsules taken orally before meals 5 capsules (2.0 g) each time three times a day
Sponsors
The First Affiliated Hospital of Anhui University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Patients with type 2 diabetes aged =18 and =75 years gender not limited; (2) Those with yin deficiency and blood stasis syndrome according to traditional Chinese medicine diagnosis; (3) Glycated hemoglobin (HbA1c) =9%; (4) Wagner classification of 1-2 with ulcer lesions below the ankle without exposure of tendons muscles joint capsules or bones and without signs of systemic infection; (5) The longest diameter of the ulcer lesion after debridement is =10 cm; if there are multiple ulcer lesions the largest area lesion is used as the observation lesion; (6) Ankle-brachial index (ABI) of the affected limb where the ulcer lesion is located is =0.6; (7) Those who voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Ulcers not related to diabetes such as rheumatic ulcers radiation ulcers and ulcers caused by vasculitis; (2) Ulcers with exposure of tendons muscles joint capsules or bones or the presence of sinus tracts that cannot be cleared by debridement; (3) Ulcer sites with severe clinical infections such as cellulitis or osteomyelitis accompanied by fever; (4) Patients with severe uncontrolled hypertension with systolic blood pressure =180 mmHg or diastolic blood pressure =110 mmHg; (5) Hemoglobin <10 g/dL; (6) Platelet count below the lower limit of normal; (7) Severe liver and kidney dysfunction; (8) Cancerous changes or malignant tumors in the ulcerated foot or patients suspected of having malignant tumors; (9) Use of any medication either orally or topically for the treatment of diabetic foot that promotes wound healing before participating in the study including traditional Chinese medicine or patent medicines that nourish yin and activate blood circulation; (10) Patients with allergic constitution or known
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ulcer area healing rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood glucose;Lower limb vascular color Doppler ultrasound examination;Traditional Chinese Medicine syndrome score;Four major lipid profiles;Postprandial blood glucose at 2 hours;Glycated hemoglobin;Ankle-Brachial Index;Foot X-ray imaging; | — |
Countries
China
Contacts
Public ContactFang Zhaohui
The First Affiliated Hospital of Anhui University of Chinese Medicine
Outcome results
None listed