Becaplermin is a recombinant human platelet-derived growth factor B-chain h
omodimer (rh-PDGF-BB) for topical treatment of full-thickness diabetic neur
opathic ulcers and pressure ulcers.
rh-PDGF-BB promotes wound healing, probably increasing granulation tissue f
ormation via migration and proliferation pf cells, with subsequent extracel
lular matrix deposition. Accelerated healing has been demonstrated in healt
hy and healing-impaired animals and in patients with lower extremity diabet
ic neuropathic ulcers and pressure ulcers.
Pharmacokinetic studies in humans have shown that systemic absorption of be
caplermin after topical administration to ulcers is minimal.
A clinical trial in patients with stage III or IV diabetic neuropathic ulce
rs of the lower extremities which had adequate perfusion showed that becapl
ermin 100 mu g/g applied once daily in conjunction with a programme of good
wound care significantly increased the proportion of patients with complet
e healing of the ulcer and reduced the time to complete healing compared wi
th placebo or good wound care alone. Becaplermin was also superior to place
bo in patients with pressure sores.
Becaplermin was well tolerated in clinical trials and the rate of discontin
uation because of adverse events was similar to that among placebo:recipien
ts. Rash, which occurred in 2% of becaplermin and 2% of placebo recipients,
may be attributable to the vehicle used.