Rees RS, Robson MC, Smiell JM, Perry BH, et al.
Wound repair and regeneration : official publication of the Wound Healing Society [and] the Eur.... Date of publication 1999 May 1;volume 7(3):141-7.
1. Wound Repair Regen. 1999 May-Jun;7(3):141-7.
Becaplermin gel in the treatment of pressure ulcers: a phase II randomized,
double-blind, placebo-controlled study.
Rees RS(1), Robson MC, Smiell JM, Perry BH.
Author information:
(1)University of Michigan Medical Center and Department of Veterans Affairs
Medical Center, Ann Arbor, USA. rreese@umich.edu
Pressure ulcers are associated with significant rates of morbidity and mortality,
particularly in the geriatric and spinal cord-injured populations. Newer
pharmacologically active therapies include the use of topically applied
recombinant human platelet-derived growth factor-BB (becaplermin), the active
ingredient in REGRANEX) (becaplermin) Gel 0.01%, which has been approved in the
United States for treatment of lower extremity diabetic neuropathic ulcers that
extend into the subcutaneous tissue or beyond and have an adequate blood supply.
In this study, the efficacy of becaplermin gel in the treatment of chronic full
thickness pressure ulcers was compared with that of placebo gel. A total of 124
adults (>/= 18 years of age) with pressure ulcers were assigned randomly to
receive topical treatment with becaplermin gel 100 microg/g (n = 31) or 300
microg/g (n = 32) once daily alternated with placebo gel every 12 hours,
becaplermin gel 100 microg/g twice daily (n = 30), or placebo (sodium
carboxymethylcellulose) gel (n = 31) twice daily until complete healing was
achieved or for 16 weeks. All treatment groups received a standardized regimen of
good wound care throughout the study period. Study endpoints were the incidence
of complete healing, the incidence of >/= 90% healing, and the relative ulcer
volume at endpoint (endpoint/baseline). Once-daily treatment of chronic pressure
ulcers with becaplermin gel 100 microg/g or 300 microg/g significantly increased
the incidences of complete and >/= 90% healing and significantly reduced the
median relative ulcer volume at endpoint compared with that of placebo gel (p <
0.025 for all comparisons). Becaplermin gel 300 microg/g did not result in a
significantly greater incidence of healing than that observed with 100 microg/g.
Treatment with becaplermin gel was generally well tolerated and the incidence of
adverse events was similar among treatment groups. In conclusion, once-daily
application of becaplermin gel is efficacious in the treatment of chronic full
thickness pressure ulcers.
PMID: 10417749 [Indexed for MEDLINE]
