Table 10.
Other growth factor and recombinant proteins: outcomes of RCTs.
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 | ||||
[29] | Topical rhVEGF (telbermin) | A positive however nonsignificant trend towards healing in the treated group | 32.5-43 days | NM | NM | NM | NM | NM | NM | 27% in the VEGF group versus 33% in the placebo group | NM |
[30] | Erythropoietin, epoetin beta | No significant results. 26.7% of patients receiving EPO achieved complete wound closure within 12 weeks, whereas only 14.3% in the placebo control arm | 44 days | NM | NM | NM | NM | NM | NM | NM | NM |
[31] | Talactoferrin gel | The active arms showed a trend toward improvement over placebo (p = 0.09) 33% complete healing after 30 days in the active group versus 19% in the placebo group | 30 days | NM | NM | NM | NM | NM | NM | NM | NM |
[32] | Chrysalin® (TP508 or rusalatide) | More than doubled the incidence of complete healing (p < 0.05), increased the mean closure rate 80% (p < 0.05), and decreased the median time to 100% closure by 40% (p < 0.05). | 80 days to 100% closure in 10 μg Chrysalin® | Y | Y | NM | NM | NM | NM | NM | 1 in 1 μg Chrysalin® |
[33] | TGF beta2 | Proportion of patients with wound closure increased in TGF-β2 at doses of 0.05 μg/cm2 (p = 0.046) and 0.5 μg/cm2 (p = 0.025) and group with standardized care treatment (p = 0.009). In total, the mean time to complete wound closure was shorter in TGF-β 0.5 μg/cm2 (p = 0.03) compared with the placebo group | 13 weeks in high-dose TGF beta | NM | NM | N | N | Y(-) | NM | NM | NM |
VEGF: vascular endothelial growth factor; TGF-β: transforming growth factor β; Y: yes; N: no; NM: not mentioned.