Study shows faster healing with use of new growth factor
March 1, 1998 2 minutes read
Study shows faster healing with use of new growth factor
Becaplermin gel reduced closure times
Use of a new genetically engineered platelet-derived growth factor called becaplermin accelerated healing and reduced the incidence of diabetic ulcers, according to a recent report by researchers.T. Jeffery Wieman, MD, professor of surgery at the University of Louisville (KY), conducted a phase III study involving 382 patients with full-thickness (stage III or IV) nonhealing lower extremity diabetic ulcers. He found that becaplermin gel administered at 100 mcg/gm resulted in a 50% complete wound closure rate, compared with a 35% rate for patients treated with the drug’s vehicle placebo alone.
Becaplermin, manufactured by Ortho-McNeil Pharmaceutical, goes by the trade name Regranax. The federal Food and Drug Administration approved the product for marketing in December.
According to the study results, becaplermin gel appeared to reduce by nearly six weeks the average time to complete wound closure. Wounds treated with becaplermin closed in an average of 86 days, compared with 127 days for those in the control group.
In a third group, which received becaplermin at 30 mcg/gm, the wound closure rate of 35% and the average time to complete wound closure of 123 days were not statistically different compared with placebo.
Wieman says becaplermin is the first biologic agent proven to have a beneficial effect on lower extremity ulcers. That, he adds, could translate into a reduction of limb loss within the large group of people who suffer from diabetic wounds. Approximately 10 million diabetic patients in the United States are at risk for developing lower-extremity ulcers and subsequent limb amputation, says Wieman.
An integrated analysis of combined data from Wieman’s trial and two other randomized studies confirmed the findings of becaplermin’s efficacy. In 672 patients, the incidence of complete wound closure was 49% for patients receiving becaplermin gel at 100 mcg/gm, vs. 33% for the placebo group.
Wieman and his colleagues also analyzed the integrated database for treatment response as measured by change in ulcer size. The benefits of becaplermin were most consistent in ulcers with a baseline area of 5 cm2 or less. For this wound subgroup, complete wound closure occurred in 55% of patients receiving becaplermin, and 38% of those receiving placebo. Times to complete wound closure were 86 days for becaplermin patients vs. 131 days for placebo patients.
For all patients enrolled in the three studies, the ulcer had been present for no less than eight weeks (with a range of 15-29 weeks), and all had undergone reasonable conventional care. Wieman noted that all experimental treatment was preceded by sharp debridement.
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