Journal of Diabetes Research / 2020 / Article / Tab 5 / Review Article
The Role of Recombinant Proteins and Growth Factors in the Management of Diabetic Foot Ulcers: A Systematic Review of Randomized Controlled Trials 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 μ g) and 0.01% FGF (500 μ g) 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.