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 1
Characteristics of RCTs evaluated PDGF safety and effectiveness.
| Ref | Study | Intervention | Type of control | Size and the old of the wound | # of patients | Antibiotics 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 |
| [8] | Phase III RCT | Becaplermin® gel (Regranex) 100 and 30 μg/g vehicle gel once daily | Placebo | >2cm2 for a period of at least 8 weeks | 382 | Y | 6.5-7.2 | Stage III or IV (IAET guide) | Moist saline-soaked gauze dressings | Y | 20 weeks | 3 months | [9] | RCT | 30 μg PDGF per g of gel once a day | Placebo | 1-100 cm2 at least 8-week duration | 118 | N | NM | NM | Non adherent saline soaked gauze | Y | 20 weeks | NM | [10] | RCT | PDGF gel once daily | Placebo hydrogel | 1-16 cm2 | 46 | N | Y | Wagner grade I | Saline moistened gauze and nonadherent wound dressing | Y | 4 months | 6 months | [11] | RCT | 0.01% rhPDGF-BB gel once a day | Standard wound care | at least 4-week duration | 20 | N | | Wagner’s grade II | Moist saline and casting | Y | 20 weeks | NM | [12] | RCT | PDGF gel 7 μg/cm2 of ulcer per day | Two active controls: antiseptics and hyperbaric oxygen therapy | 8-week duration | 60 | Y | NM | Equals to Wagner grade II, III | Saline moistened gauze | NM | 10 weeks | NM | [13] | RCT | rhPDGF gel 0.01% | Active: KY Jelly (Ethnor) | 26-30 cm2 at least 4-week duration | 50 | Y | NM | IAET stage III and IV | Moist dressing | Y | 10 weeks | NM | [14] | RCT (phase III) | 0.01% PDGF gel containing 100 μg/g | Placebo | 1-40 cm2 at least 4 weeks | 111 | Y | <12% | | Moist saline gauze | Y | 20 weeks | NM | [15] | RCT | Regranex (PDGF) 0.01% plus TheraGuaze | Active (TheraGuaze) | 1-8 cm2 | 32 | NM | <10% | Wagner grade I/II | TheraGuaze | Y | NM | Study period: 20 weeks |
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PDGF: platelet-derived growth factor; Y: yes; N: no; NM: not mentioned; IAET: International Association of Enterostomal Therapy.
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