diabetic foot ulcer
Conditions
Interventions
1: bitotype wound matrix materials
2:Lipid hydrocolloid dressings
Sponsors
Zhongda Hospital,Affiliated to Southeast University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. aged between 18 and 75 years old patients with the clinical diagnosis of a single wound diabetic foot ulcer; 2. patents with diabetic foot ulcers Wagner grade 2 to 3 , or after treatment to 2 to 3; 3. patients with fasting blood glucose =8mmol/L, 2h postprandial blood glucose =11mmol/L; 4. patients with blood pressure = 160/95mmHg (1mmHg = 0.133kPa); 5. patients with the ankle brachial index (Ankle-Brachial Index, ABI) =0.6.
Exclusion criteria
Exclusion criteria: 1. The ABI is still less than 0.6 after treatment for vascular disease patients; 2. The infection is still 4 in the infection classification after treatment, according to PEDIS grading system; 3. The patients with cancer; 4. The patients with cancerous ulcers, autoimmune ulcers, drug ulcers and other specific ulcers; 5. The patients received radioactive, systemic steroids, chemotherapy, immunosuppressive therapy; 6. The patients received other functional dressing treatment on target ulcer in the last 7 days; 7. severe allergies; 8. severe malnutrition (hypoproteinemia, albumin =25g/L); 9. The patients with liver and kidney dysfunction, that is, serum ALT and/or AST>120U/L, Crea>176umol/L; 10. The patients with cerebral infarction, myocardial infarction or severe heart rate in the last 6 months; 11. Pregnancy, breastfeeding, planned pregnancy or urine test during pregnancy is positive; 12. participated in other clinical trials in the last 3 months; 13. The patients are not suitable for entry into this clinical trial considered by researchers; 14. religion or culture against the use of pig products, as well as allergic to pig-derived materials; 15. People with mental illness, severe heart, lung, blood system diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of wound healing after 12 weeks; the rate of base shrinkage after 12 weeks; | — |
Countries
China
Contacts
Public ContactDapeng Chen
Guangzhou Sinoregen Medical Materials Co. Ltd.
Outcome results
None listed