| Methods | Randomized controlled parallel study design: the treatment group and the control group were 30 cases each according to the ratio of 1 to 1. Allocation concealment process and blinding were not mentioned. | |
| Participants | Ethnicity: Chinese Setting: inpatients 60 patients with DFU were all in line with the WHO diagnostic criteria for diabetes and complications in 1985, and the course of DM must be more than 12 months. Among them, 36 were male and 24 were female, 4 were insulin-dependent diabetes (IDDM), 58 were non-insulin-dependent diabetes (NIDDM), the average age was (64.21 ± 8.1) years (41 - 80 years), and the average course was (10.71 ± 6.32) years (1 - 23 years). Exclusion criteria: not stated Withdrawals and drop-outs: not stated Characteristics of patients at baseline: similar. | |
| Interventions | Treatment group: Cortex Phellodendri, earthworm and Resina Draconis mixed at the ratio of 3:2:1. Bandaged with sterile gauze q.d for 30 days as a course of treatment (2 courses) Control group: 1% Ethacridine Lactate | |
| Outcomes | 1 Effective rate: 1) cure: the wound is completely covered with new derma; 2) remarkable improved: more than 1/2 ulcer area closed up; 3) improved: 1/4 - 1/2 ulcer area closed up; 4) not improved: less than 1/4 wound area closed up or enlarged 2 Clinical outcomes: not improved, amputated, dead 3 Ulcer area change: purulent exudate, red and swollen, pain, exfoliation of slough, the growth of granulation tissue | |
| Notes | 1 The formulation of YHS was provided by authors’ department. 2 YHS was made by the author’s hospital. | |
| Risk of bias | ||
| Bias | Reviewers’ judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Adequate |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding (performance and detection bias) | Unclear risk | Not mentioned |
| Incomplete data bias | Low risk | No missing outcome data |
| Selective reporting bias | Low risk | All the expected outcomes reported in details |
| Other bias | High risk | The formulation of YHS was provided by author’s department, and it was made by the author’s hospital. |