Table 8.
Outcomes of RCTs that evaluated G-CSF safety and effectiveness.
Ref | Type of growth factor | Wound closure | Mean time to heal in treatment groups | Mechanism mentioned as complete healing | Confounders | Further outcomes | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
Granulation tissue | Reepithelialization | Sex | Baseline HbA1c | Wound size | Offloading | Recurrence rate | Amputation rate | ||||
[25] | G-CSF | G-CSF therapy was associated with earlier eradication of pathogens from the infected (p = 0 · 02), quicker resolution of cellulitis (p = 0 · 03), shorter hospital stays (p = 0 · 02), and a shorter duration of intravenous antibiotic (p = 0 · 02). Neutrophil superoxide production was higher in the G-CSF-treated group (p < 0 · 0001) | NM | NM | NM | NM | NM | NM | NM | NM | 2 cases in the placebo group |
[28] | G-CSF | At the 3- and 9-week assessments, no significant differences in terms of complete closure of the ulcer without signs of underlying bone infection | NM | NM | NM | NM | NM | NM | NM | NM | 15% in the G-CSF group and 45% in the control group. p = 0.03 |
[26] | G-CSF | No foot ulcer had completely healed at the end of the study. Patients who received G-CSF did not have an earlier resolution of clinically defined cellulitis (p = 0.57). The ulcer volume, was reduced by 59% in G-CSF and by 35% in placebo patients (p = 0.0005) | NM | NM | NM | NM | NM | NM | NM | NM | 2 cases in total from both groups |
[27] | G-CSF | No significant differences for duration of hospitalization, duration of parenteral antibiotic administration, time to resolution of infection, and need for amputation | NM | NM | NM | NM | NM | NM | NM | NM | 13.3% in the treatment group and 20% in the placebo group. p > 0.05 |
G-CSF: granulocyte colony-stimulating factor; Y: yes; N: no; NM: not mentioned.