In a large, 20 week, multicenter, double-blind, placebo controlled trial of 382 patients with lower extremity diabetic neuropathic ulcers, REGRANEX® Gel significantly increased the incidence of complete healing:
50% for REGRANEX Gel (n=123) vs. 35% for placebo gel (n=127), p=0.007)
- All ulcers
o extended in to the subcutaneous tissue or beyond,
o had adequate blood supply, and
o were of at least 8 weeks duration.
- All patients received good ulcer care: initial and ongoing debridement, twice-daily dressing changes, off-loading of pressure, if applicable, and infection control
- Life Table Estimates of the Incidence of Complete Healing over Time predicted that by Week 14, 37% of patients treated with REGRANEX Gel and good ulcer care would completely heal.
- It took 6 more weeks for the control group to achieve the same incidence of complete wound closure
- Adverse experiences were similar across all treatment groups, and were not unexpected for a middle-aged population with diabetes. But see Important Safety Information including Boxed Warning, below.
- REGRANEX® Gel significantly increased the incidence of complete healing.
- REGRANEX® Gel reduced the time to healing by 32%, nearly 6 weeks faster (P=0.013),