FDA approves gel for diabetic ulcers

New biologic stimulates body to grow new tissue

The U.S Food and Drug Administration in Rockville, MD, recently granted marketing clearance of Regranex (becaplermin) Gel 0.01%, a biologic proven to increase the incidence of complete healing in diabetic foot ulcers, according to the gel’s marketer, Ortho-McNeil Pharmaceutical in Raritan, NJ.

The topical gel contains genetically-engineered platelet-derived growth factor, which actively stimulates the body to grow new tissue to heal wounds. When used in conjunction with good ulcer care, Regranex Gel is indicated in the treatment of lower-extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply.

In clinical trials, a once-daily application of Regranex Gel and good ulcer care healed more diabetic ulcers than placebo gel and good ulcer care. Good ulcer care, as practiced in the clinical trials, included:

• initial sharp debridement to remove dead tissue;

• ongoing debridement as necessary;

• no weight on affected area to relieve pressure points;

• systemic treatment of wound infections if present with no use of topical antibiotics or antiseptics;

• maintenance of a moist wound environment with twice-daily dressing changes;

• assessment of oxygen perfusion.

"Wound healing is a complex process that, until now, only Mother Nature could influence," says David L. Steed, MD, professor of surgery at the University of Pittsburgh and a Regranex trial investigator. "Now we have something that no drug has offered before, a simple, easy-to-use treatment that actually stimulates the body to heal more diabetic ulcers."

The gel is available in pharmacies this month and costs $378 for a 15 g tube. If used correctly, each tube provides a three- to four-week supply of gel depending on the size of the wound. For more information, call toll-free at (800) 542-5365.