diabetic foot
Conditions
Interventions
Experimenta:application of the Fusion Protein, 3 times a day, for a period of 4 weeks.
control:application of sterile normal saline, 3 times a day, for a period of 4 weeks.
Sponsors
General Hospital of Jinan Military Command
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. aged 18-70 years; 2. type 1 or 2 diabetes mellituswhose blood sugar levels could be controlled; 3. Wagner's grades 1 and 2 DFU, no infection except the diabetic food ulcer; 4. Adequate arterial blood flow at the corresponding limb as evidenced by an ankle brachial index (ABI) of > 0.8 and =20 mmHg must be present; 5. A target ulcer which is not less than 1 cm2; 6. Willing and able to follow instructions; 7. signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Lactating and pregnant women, and those of childbearing potential not using reliable contraceptive methods; 2. surgical procedure other than debridement on the study ulcer foot in 4 weeks; 3. Patients with acute complications; 4. Patients with stroke or Lumbar diseases resulting in obstacles of consciousness or movement of Lower limbs; 5. Malignant lesions in the ulcer; 6. malnutrition ,Hemoglobin(HB)=180/110mmHg; 8. With serious abnormal function of heart, liver, kidney and other vital organs; 9. alcohol or drug abuse; 10. Expected lifetime is no more than 6 months; 11. medical conditions that in the justified opinion of the investigator would make the patient an inappropriate candidate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of healed wound; | — |
Secondary
| Measure | Time frame |
|---|---|
| healing time of the wound;quantificated indexes;the total effective rate;Changing rate of the wound size; | — |
Countries
China
Contacts
Public ContactQingying Chen
General Hospital of Jinan Military Command
Outcome results
None listed