This study was to investigate the efficacy and safety of Nocardia rubra Cell Wall Skeleton (NCWS) in the treatment of diabetic foot ulcer wounds. The study was a prospective, randomized, controlled, multicentre study . The subjects were randomly divided into two groups: NCWS group and control group(silver ions dressing), with a total of 116 cases and 58 cases in each group. Patients in the NCWS group received nocardia rubra cell wall skeleton for external use, in parallel with silver ions dressing treatment. The efficacy and side effects were observed, with a primary endpoint of 30-days wound healing rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
116
Nocardia rubra cell wall skeleton for external application
Silver ions dressing for external application
Wound healing rate up to 30 days
The wound healing rate for 30 days treatment(physiological parameter)
Time frame: 30 days after first medicine application
Healing time
The time with complete closure of wound within 30 days treatment
Time frame: From date medicine application until the complete closure of wound, assessed up to 30 days
Healing rate
The rate of complete closure of wound for 30 days treatment
Time frame: 30 days after first medicine application
Surgical intervention rate
The rate of Surgical intervention for 30 days treatment(physiological parameter)
Time frame: From first medicine application to 30 days
Pathogenic bacteria positive rate
The rate of Pathogenic bacteria positive for 30 days treatment(physiological parameter)
Time frame: 30 days after first medicine application
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