Recombinant human platelet-derived growth factor-BB for the treatment of chronic pressure ulcers.
A randomized phase I/II double-blind, placebo-controlled study was designed to evaluate 1, 10, and 100 micrograms/ml (0.01, 0.1, and 1.0 micrograms/cm2) recombinant human BB homodimeric platelet-derived growth factor (rPDGF-BB) applied topically to chronic pressure ulcers for 28 days. Twenty patients were enrolled and completed the trial. No toxicities were associated with rPDGF-BB treatment. Patients treated with 100 micrograms/ml of rPDGF-BB had a pronounced healing response compared with placebo-treated patients. By day 29, ulcers treated with 100 micrograms/ml of rPDGF-BB were smaller in remaining size compared with those of placebo-treated patients when the following specific parameters were measured: percentage of initial depth (14.1 +/- 7.4 vs. 34.9 +/- 6.7) and percentage of initial volume (6.4 +/- 4.0 vs. 21.8 +/- 5.6). Histological analyses of biopsies revealed active wound healing processes in all groups with no disruption in the normal healing sequence in rPDGF-BB-treated wounds. The results of this small, descriptive study suggest rPDGF-BB is a potent vulnerary agent for accelerating soft-tissue repair, warranting further study.
Robson
M C
MC
Department of Surgery, University of Texas Medical Branch, Galveston 77555.
Phillips
L G
LG
Thomason
A
A
Altrock
B W
BW
Pence
P C
PC
Heggers
J P
JP
Johnston
A F
AF
McHugh
T P
TP
Anthony
M S
MS
Robson
L E
LE
D000287:Administration, Topical; D000328:Adult; D000704:Analysis of Variance; D004311:Double-Blind Method; D006801:Humans; D010982:Platelet-Derived Growth Factor / Q000008:administration & dosage / Q000627:therapeutic use*; D003668:Pressure Ulcer / Q000188:drug therapy*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D014945:Wound Healing / Q000187:drug effects
D010982:Platelet-Derived Growth Factor; D011994:Recombinant Proteins