Table 7.
Characteristics of RCTs that evaluated G-CSF safety and effectiveness.
| Ref | Study | Intervention | Type of control | Size and the oldness of the wound | No. of patients | Antibiotic application during the treatment period (if needed) | Baseline HbA1C (%) | Types of wound and grade of wound | Dressing type | Offloading | Treatment duration | Follow-up period posttherapy |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| [25]. | RCT | Subcutaneous injection of G-CSF or saline solution for 7 days. The initial dose of G-CSF was 5 μg/kg daily. The dose was lowered to 2.5 μg/kg daily if, after two doses, the absolute neutrophil count was higher than 25∗109/L | Placebo | >2 cm2 More than 8 weeks |
40 | Y | 5·5–13·7% | NM | Standard foam dressings | NM | 7 days | NM |
| [28] | RCT | Conventional antimicrobial treatment plus 263 mg of G-CSF subcutaneously daily for 21 days | Placebo | NM | 40 | Y | Y | Wagner grade III or IV | NM | Bed rest | 21 days | 6 months |
| [26] | RCT | 5 μg/kg G-CSF (injected subcutaneously) or placebo daily. | Placebo | 0.5-3 cm | 37 | Y | <12% | Wagner grade II or III | NM | Bed rest | 10 days | NM |
| [27] | RCT | Subcutaneous injection of G-CSF and/or conventional therapy. The initial daily dose of G-CSF was 5 μg/kg. After three consecutive doses, if the absolute neutrophil count was >30∗109/L, the dose was changed to 2.5 μg/kg daily on alternate days | Placebo | NM | 30 | Y | NM | Wagner grade II | NM | NM | NM | NM |
G-CSF: granulocyte colony-stimulating factor; Y: yes; N: no; NM: not mentioned.