A trial to determine if daily topical applications of becaplermin gel is successful in treating patients with pressure ulcers. Topical becaplermin has been shown to have significant effects on wound healing in mice, rats, guinea pigs, and domestic pigs. The usual action of becaplermin in these animal models is to promote the formation of granulation tissue in the wound. The toxicology of becaplermin has been evaluated in the mouse, rat, rabit, guinea pig, dog, and monkey. The results of these studies indicate that becaplermin has minimal toxicity intravenously, under the skin, and on top of the skin. Preclinical and clinical studies indicate that becaplermin gel is safe and effective in the treatment of diabetic ulcers. Studies in patients with full thickness diabetic ulcers showed negligible absorption. The clinical assessment of absorption in subjects with pressure ulcers has only been conducted with 30 ug/g gel formation. This study will further evaluate the extent of systematic absorption of becaplermin from a topically applied 100 ug/g gel formation in subjects with pressure ulcers using state-of-the-art analytical and sample preparation techniques. At least twelve subjects will be studied. Subjects must have full thickness pressure ulcers, not be pregnant, must have ulcers free of joint capsule or bone exposure, must have ulcers that are free of narcotic and infected soft tissue, negative hepatitis B tests, must not comsume alcohol for 48 hours prior to the study and until the end of the study, and must give written, informed consent. Following a screening period, during which subjects will have serial blood samples collected at specific times to establish baseline fluid growth concentrations of PDGF-BB, subjects will apply becaplermin gel 100ug/g once daily for two weeks. Subjects will be confined for 24 hours for collection of serial blood samples on days 1 and 14 of the therapy. Prior to study drug administration on days 1 and 14, a serum collection for anti-PDGF antibody will occur. Final study procedures will be performed on day 15.
Showing the most recent 10 out of 367 publications
