Diabetic foot
Conditions
Interventions
low-dose group:The low-dose gourp will be treated by 18µg mNGF based on basic treatment
middle-dose group:The middle-dose gourp will be treated by 36µg mNGF based on basic treatment
high-dose group:The high-dose gourp will be treated by 54µg mNGF based on basic treatment
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old, BMI=18.5 male and female; 2. Clinical diagnosis of diabetic foot ulcers,it satisfies the Wagner classification method 2-3; 1) If there are multiple ulcers,then choose one as a test object; 2) Ulcer wounds can be measured,and the wound area of 5-20 cm2; 3) If combined infection,the wound area is larger,bone and joint with deep abscess,to be treated(including foot decompression,debridement,anti-infection,etc.)to the fresh granulation tissue began to grow; 4) 4.4mmol/L=fasting glucose=8.0mmol/L,2h postprandial blood glucose=10.0mmol/L; 5) The test-side ankle-brachial index(ABI)was 0.6-1.3; 6) Willing to submit to this pilot program and sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: (1) Non-diabetic foot ulcers,such as electricity,chemical,radioactive and other causes of skin ulcers,paraplegia; (2) X-ray examination combined with osteomyelitis; (3) Wounds have a special pathogen infection(such as tuberculosis,syphilis,or infection was obvious,such as cellulitis>2cm2; (4) Wounds and other lesions to form sinus tract and can not implement debridement; (5) Where the ulcer is cancerous; (6) Can not well control of blood glucose(fasting blood glucose>8.0mmol/L or 2h blood glucose>10.0mmol/L or glycated hemoglobin>9%),and all types of diabetic coma; (7 )Hemoglobin2.5 times the upper limit of normal,Cr>200µmol/L; (10) Previously had a history of severe cardiovascular disease; (11) Had a malignant or suspected malignancy; (12) Complications of organ damage or medical problems that would jeopardize their ability to attend this study or heal their wounds; (13) Pregnant or lactating women or who plan to become pregnant within 3 months; (14) Allergic to any ingredient in the test drug; (15) Who have participated in other new drug clinical trials in the last 3 months; (16) Due to serious mental or language barriers can not be completed according to clinical trial program researchers; (17) Patients who underwent treatment with the same type of NGF and/or took drugs that might interfere with the study (neuroprotectives) discontinued less than 14 days; (18) Four weeks thought to use immunosuppressive agents or corticosteroids; (19) Researchers believe that for other reasons should not participate in this clinical trail.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of complete wound healing; | — |
Secondary
| Measure | Time frame |
|---|---|
| Thepercentage of complete wound healing;The number of days required for wound healing;The rate of wound healing; | — |
Countries
China
Contacts
Public ContactChunmao Han
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed