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Johnson & Johnson study confirms Regranex gel effective treatment of foot ulcers
By Lisa Kerner
Erie, Pa., Jan. 23 - Johnson & Johnson Wound Management, a division of Ethicon, Inc., said it released the results of a study designed to estimate the effectiveness of recombinant human platelet-derived growth factor (rhPDGF) in actual clinical practice.
The study showed that diabetic neuropathic foot ulcers treated with rhPDGF were 32% more likely to heal within 20 weeks than those not treated with rhPDGF, according to a company news release.
RhPDGF is marketed as Regranex (becaplermin) Gel 0.01%.
The retrospective patient cohort study used a claims database to evaluate more than 24,000 patients with neuropathic diabetic foot ulcers. The patients were treated at specialty wound clinics between 1998 and 2004.
The results were similar to the results of previous randomized controlled trials of Regranex Gel, the company said.
"Our study looked at how rhPDGF performs in clinical practice and demonstrated that it achieves similar results in the real world as in the ideal setting," lead researcher David J. Margolis, MD, said in the release.
Regranex Gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply.
The efficacy of Regranex Gel has not been established for treatment of pressure ulcers and venous stasis ulcers, or for diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue or ischemic diabetic ulcers.
The study results were published in the November-December 2005 edition of Wound Repair and Regeneration.
Johnson & Johnson Wound Management specializes in products for chronic and acute wound management and hemostasis. The company is based in Somerville, N.J.
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