REGRANEX® (Becaplermin) Gel Is Effective Treatment Of Diabetic Neuropathic Foot

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REGRANEX® (Becaplermin) Gel Is Effective Treatment Of Diabetic

Neuropathic Foot Ulcers, Study Confirms

http://www.medicalnewstoday.com/medicalnews.php?newsid=36788

& Wound Management, a division of ETHICON, INC.,

today announced the publication of results in a study designed to

estimate the effectiveness of recombinant human platelet-derived

growth factor (rhPDGF) in actual clinical practice. The study,

published in the November-December 2005 edition of Wound Repair and

Regeneration, showed that diabetic neuropathic foot ulcers treated

with rhPDGF were 32 percent more likely to heal within 20 weeks than

those not treated with rhPDGF (802/2394 vs. 5806/22504). RhPDGF is

marketed as REGRANEX® (becaplermin) Gel 0.01%.

The retrospective patient cohort study utilized a claims database to

evaluate more than 24,000 patients with neuropathic diabetic foot

ulcers who were treated at specialty wound clinics between 1998 and

2004. Patients who had received rhPDGF were more likely to have

healed at 20 weeks versus those treated with other methods of ulcer

care. These results were similar to the results of previous

randomized controlled trials of REGRANEX® Gel.

" Clinical studies show how something works in an ideal setting, "

stated J. Margolis, M.D., Ph.D., Departments of Dermatology and

Biostatistics and Epidemiology, University of Pennsylvania School of

Medicine and lead researcher. " 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. "

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. When used as an adjunct

to, and not a substitute for, good ulcer care practices including

initial sharp debridement, pressure relief and infection control,

REGRANEX® Gel increases the incidence of complete healing of diabetic

ulcers.

The efficacy of REGRANEX® Gel has not been established for treatment

of pressure ulcers and venous stasis ulcers (see Clinical Studies),

and has not been evaluated for the treatment of diabetic neuropathic

ulcers that do not extend through the dermis into subcutaneous tissue

(Stage I or II, IAET staging classification) or ischemic diabetic

ulcers.

Important Safety Information

REGRANEX® Gel is contraindicated in patients with known neoplasms at

the site of application or with known hypersensitivity to any

component of this product (e.g. parabens). Erythematous rashes

occurred in two percent of patients treated with REGRANEX® Gel or

placebo gel. REGRANEX® Gel should not be used in wounds that close by

primary intention.

For Full Prescribing Information or more information about REGRANEX®

Gel, visit http://www.regranex.com.