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

>2cm^2 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 cm^2

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/cm^2 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 cm^2 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 cm^2

32

NM

<10%

Wagner grade I/II

TheraGuaze

Y

NM

Study period: 20 weeks

PDGF: platelet-derived growth factor; Y: yes; N: no; NM: not mentioned; IAET: International Association of Enterostomal Therapy.