Indications for REGRANEX:
Adjunct in the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply.
Limitations of Use:
Not for use in wounds that close by primary intention. Efficacy not established for the treatment of pressure ulcers and venous stasis ulcers.
≥16yrs: Apply once daily until complete healing has occurred. Measure size of ulcer and adjust at 1–2 week intervals. Calculate amount of gel needed based on ulcer size. Length of gel (in cm) to be applied daily = (length x width of wound area in cm2) ÷ 4. Or, length of gel (in inches) to be applied daily = (length x width of wound area in inches2) x 0.6. Squeeze calculated length of gel from tube onto clean measuring surface (eg, wax paper). Spread gel over entire ulcer to thickness of about 1/16 inch. Cover with saline dressing for about 12hrs. Remove dressing and rinse. Replace with clean saline dressing (no gel). Reevaluate if ulcer does not decrease in size by about 30% after 10 weeks, or if complete healing has not occurred after 20 weeks.
<16yrs: not established.
Neoplasm(s) at application site.
Malignancies distant from the application site have occurred. Evaluate prior to initiation in those with known malignancy. Application site reactions (eg, sensitization, irritation); consider interruption or discontinuation. Pregnancy. Nursing mothers.