Table 2.
Outcomes of RCTs that evaluated PDGF 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 | ||||
[8] | PDGF-Becaplermin® | 50%, 35%, and 36% of complete healing in 100 μg/g Becaplermin® gel and placebo and 30 μg/g Becaplermin® gel, respectively | 86 days for 100 μg/g Becaplermin® gel (decreased time by 32%) | NM | NM | NM | N | N | Y(+) | 30% in all groups | NM |
[9] | rhPDGF-BB gel | 48% complete healing in the PDGF group compared with 25% in the placebo group p = 0.01 | 30 days in the PDGF and 40 days in the placebo group. p = 0.01 | NM | NM | NM | NM | NM | NM | 26% in PDGF treated versus 46% | NM |
[10] | Topical PDGF | 52% of healing in the test group versus 57% of healing in the control group (not significant) | 16 weeks | NM | Y | NM | N | Y(-) | Y(+) | NM | 3 cases in total |
[11] | rhPDGF-BB gel | All ulcers in both groups had healed by the end of the study period | 50.10 ± 23.38 days 41.8% reduction in healing time (p = 0.02) | NM | NM | NM | NM | N | Y(+) | NM | NM |
[12] | PDGF | Percentage of patients with complete wound contraction was significantly (p = 0.03) higher in the PDGF group compared to the other groups | 6.75-7.6 weeks Not significant |
NM | NM | NM | NM | N | NM | NM | NM |
[13] | PDGF | 18 (72%) ulcers had healed in the control group and 15 (60%) in the test group (p > 0.05). Three ulcers in the control group showed >75% reduction in size compared to 2 in the test group (p > 0.05). | 10 weeks | NM | NM | NM | NM | NM | NM | NM | NM |
[14] | PDGF gel | A significantly higher (p < 0.01) percentage of patients in the rhPDGF-based gel-treated group achieved complete healing | 46 days (p < 0.001) | NM | Y | NM | NM | Y(-) | NM | NM | NM |
[15] | PDGF | The rates of wound closure with TheraGauze and TheraGauze + Becaplermin® were 0.37 and 0.41 cm2/week, respectively (p = 0.34) | 12 weeks | NM | Y | NM | NM | NM | NM | NM | N |
PDGF: platelet-derived growth factor; Y: yes; N: no; NM: not mentioned.