Table 5.
Characteristics of RCTs that evaluated FGF 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| [21] | RCT | Topical rhaFGF (liquid) and rhbFGF at a dose of 100 U/0.1 mL/cm2 | Active (bFGF) | >2 cm in diameter At least 8 weeks |
139 | N | NM | NM | Sterile cotton dressings without antibiotics | NM | 6 weeks | NM |
| [22] | RCT | 4 groups: hEGF (liquid) at 40 IU/cm2 and aFGF at 40 AU/cm2 or hEGF at 40 IU/cm2 or topical aFGF 40 AU/cm2 or the wound was cleaned with normal saline only |
Placebo | >3 cm2 At least 12 weeks |
199 | N | NM | Grade II Wagner | NM | NM | 60 days | NM |
| [23] | RCT | Liquid bFGF spray, 500 ng-100 ng/wound | Placebo | > 0.5 cm More than a year |
17 | Y | 7.1-7.9 | Wagner grades I–III | Sterile petrolatum impregnated gauze (no antiseptic) | Y | 18 weeks | NM |
| [24] | RCT | 0.001% bFGF (50 μg) and 0.01% FGF (500 μg) spraying once a day | Placebo | 900 mm2 or less | 150 | Y | 10-16 | Wagner grade II | Silicone gauze | Y | 8 weeks | NM |
FGF: fibroblast growth factor; Y: yes; N: no; NM: not mentioned.