Table 9.
Other growth factor and recombinant proteins: characteristics of RCTs.
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| [29] | Phase I trial (RCT) | Topical telbermin (rhVEGF) (72 μg/cm2) in conjunction with standard every 48 hours for up to six weeks | Placebo | 1-4 cm2 Between 4 and 6 months old |
55 | Y | 5.5-13.6% | Grade 1A | Covered with a sterile, semipermeable barrier and then wrapped with cotton gauze | Y | 6 weeks | 7-12 weeks |
| [30] | RCT phase IIa study | Epoetin beta injected at a weight-adjusted dose of approximately 30 IU/kg/week subcutaneously plus standard treatment | Placebo | 4.09 ± 5.09 cm2 for a duration of 16.48 ± 18.58 months | 22 | NM | <8% | Wagner grade I or II | NM | Y | 12 weeks | 12 weeks |
| [31] | RCT phase I/II | 2.5% or 8.5% talactoferrin gel administered topically twice daily to the ulcers with standard wound care | Placebo | 0.5 to 10 cm2 At least 4 weeks |
46 | Y | 6-13% | NM | Saline dressing | Y | 12 weeks | Up to 6 months |
| [32] | RCT phase I/II | 1 or 10 μg Chrysalin® or saline as placebo | Placebo | 0.1-8.5cm2 More than 8 weeks |
40 | Y | NM | Wagner grades I, II, or early III | NM | Y | 20 weeks | NM |
| [33] | RCT | Five groups: standard care, topical placebo collagen sponge, or topical collagen sponge containing TGF-β2 either at 0.05, 0.5, or 5 μg/cm2 | Placebo | 1-20 cm2 more than 8 weeks old | 177 | NM | <13% | NM | Collagen sponge and nonadherent dressing | Y | 21 weeks | 3 months |
VEGF: vascular endothelial growth factor; TGF-β: transforming growth factor β; Y: yes; N: no; NM: not mentioned.