| Methods | Randomized controlled parallel study design: randomly divided into two groups via a computer random number generator Allocation concealment process and blinding were not mentioned. | |
| Participants | Ethnicity: Chinese Setting: inpatients Western Medicine diagnostic criteria: 60 patients were in accordance with the report of Chinese Diabetes Society’s (CDS) second meeting concerning diagnosis of DFU in 2000: DM patients whose acral skin appeared vesicle, blood blister, erosion, ulcer, gangrene or necrosis. Chinese Medicine diagnostic criteria: 60 patients were in line with Guiding Principles for clinical research of new Chinese Medicine (1997), Surgery of traditional Chinese medicine (2007) and Diagnostic criteria of therapeutic effect of surgical diseases and syndromes in Chinese traditional medicine (ZY/TOO 1.1 - 94). Among them, 33 were male and 27 were female; mean age (58.34 ± 10.72) years (34 - 74); mean DM duration was (14.23 ± 10.86) years (11 months - 26 years) Exclusion criteria: not stated Withdrawals and drop-outs: not stated Characteristics of patients at baseline: similar. | |
| Interventions | Treatment group: YHS (Cortex Phellodendri 60 g, earthworm 30 g and Resina Draconis 10 g) q.d for 28 days Control group: Metronidazole and Glucose Injection q.d for 28 days | |
| Outcomes | 1 Therapeutic effect on DFU: reference to Nimodipine and therapeutic effect evaluation criterion on quantization integral 2 Healing rate: healing rate = (ulcer area before treatment- not healed ulcer area)/ulcer area before treatment 3 Serum hs-CRP, TNF-α, IL-1, VEGF, EGF, AGEs 4 Morphological observation of paraffin section of granulation tissue | |
| Notes | 1 The formulation of YHS was provided by authors’ department. 2 YHS was made by the author’s hospital. 3 The first author in this study was Yang BH’s student. | |
| 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. |