1. Section Editor(s): Hess, Cathy Thomas BSN, RN, CWOCN

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Diabetic Ulcers

Johnson & Johnson Pharmaceutical Research and Development, Raritan, NJ, is sponsoring an interventional Phase III study to evaluate the efficacy and safety of becaplermin (REGRANEX Gel) versus placebo when applied to recurring or nonhealing, neuropathic diabetic lower-extremity ulcers for up to 52 consecutive weeks. This includes an initial treatment period of up to 20 weeks with becaplermin or up to 2 retreatment episodes.


Approximately 200 participants (male and female, aged 18 to 80) are expected to be enrolled in the study. Participants must have type 1 or 2 diabetes mellitus, a glycohemoglobin A1C less than 12%, and a minimum of 1 neuropathic, diabetic ulcer meeting study criteria. Adequate arterial circulation to the foot must be evidenced by palpable ankle pulses or other acceptable noninvasive vascular testing.


Participants must be willing to comply with study gel application and dressing change instructions; remain nonweightbearing and/or prevent rubbing (shear injury) on the treated ulcer site(s) for the duration of the study; and adhere to the study requirements or have adequate caretaker assistance.


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Urinary Incontinence

Phase III study data indicate that oxybutynin transdermal system (Oxytrol), a product of Watson Pharmaceuticals, Inc, Corona, CA, is effective, well tolerated, and significantly reduces the number of incontinent episodes associated with overactive bladder, with a low incidence of anticholinergic adverse effects.


Oxytrol is a thin, flexible, clear patch that should be applied to the abdomen, hip, or buttock twice weekly. The transdermal delivery system delivers 3.9 mg per day of oxybutynin consistently and continuously through the skin into the bloodstream, bypassing the initial metabolism in the liver and the gastrointestinal tract that occurs with oral medications, providing relief of overactive bladder symptoms for up to 4 days.


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