A phase II study to evaluate recombinant platelet-derived growth factor-BB in the treatment of stage 3 and 4 pressure ulcers.
OBJECTIVE
To determine the efficacy of the daily topical application of recombinant platelet-derived growth factor-BB (rPDGF-BB), a recognized vulnerary agent, in the treatment of deep pressure ulcers.


METHODS
Prospective, randomized, double-blind trial.


METHODS
Patients were treated in a nursing home or a hospital setting before transfer to a nursing home.


METHODS
Eligibility criteria included a clean pressure ulcer that had been adequately debrided and the absence of severe cardiac, pulmonary, or renal conditions. The causes of the ulcers were not related to a venous or arterial vascular disorder. The patients were elderly (mean age, 68 to 74 years).


METHODS
After randomization, patients were given daily topical aqueous rPDGF-BB (dosage, 100 or 300 micrograms/mL) or placebo and saline gauze dressings were applied daily in addition to frequent turning.


METHODS
Serial volume measurements of the healing wounds were taken using alginate molds.


RESULTS
The ulcers of 41 patients were analyzed. At the end of 28 days, median ulcer volumes had decreased to 83%, 29%, and 40% of the initial size in the groups receiving placebo, rPDGF-BB, 100 micrograms/dL, and rPDGF-BB, 300 micrograms/mL, respectively. When adjusted for initial volume, ulcer volume after 28 days of treatment was smaller in the rPDGF-BB-treated groups compared with the placebo group (analysis of covariance, P = .056). Ulcers in the two rPDGF-BB-treated groups were significantly smaller in volume compared with those in the placebo group, using a linear contrast procedure.


CONCLUSIONS
Data from this small trial suggest that local application of rPDGF-BB may be of therapeutic benefit in accelerating the healing of chronic pressure ulcers.
Mustoe
T A
TA
Division of Plastic and Reconstructive Surgery, Northwestern Medical School, Chicago, Ill.
Cutler
N R
NR
Allman
R M
RM
Goode
P S
PS
Deuel
T F
TF
Prause
J A
JA
Bear
M
M
Serdar
C M
CM
Pierce
G F
GF
D000287:Administration, Topical; D000368:Aged; D000077214:Becaplermin; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015993:Life Tables; D008297:Male; D010919:Placebos; D010982:Platelet-Derived Growth Factor / Q000008:administration & dosage / Q000627:therapeutic use*; D003668:Pressure Ulcer / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies; D020574:Proto-Oncogene Proteins c-sis; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D013997:Time Factors; D014945:Wound Healing
D010919:Placebos; D010982:Platelet-Derived Growth Factor; D020574:Proto-Oncogene Proteins c-sis; D011994:Recombinant Proteins; D000077214:Becaplermin