Clinical study

GRAFIX Placental Membrane: Significant reduction of the likelihood of new or recurrent diabetic foot ulcers (DFUs) compared with other cellular- and tissue-based products


Study overview

Observational study of data from 7,869 Medicare claims, comparing effectiveness of GRAFIX Cryopreserved Membrane with other cellular- and tissue-based products (cellular and acellular) in an outpatient setting:

  • GRAFIX Membrane: n=786
  • Cellular products: n=4,546
  • Acellular products: n=2,537

Any new or recurrent DFUs, mortality and DFU-related infections were assessed at 30, 90, 180 and 365 days after completing treatment

Results

  • Significant reduction in the likelihood of a new or recurrent DFU (all time points; p<0.05)
  • Favorable indirect effect on average mortality rate at 1 year*
  • Lower occurrences of cellulitis/abscess of the foot and toe (versus other cellular products; most time points)
Graph of the average likelihood of a DFU claim

Watch Jaideep Banerjee, Ph.D., MSL-BC, BCMAS, and Thomas Groner, DPM, CWS, discuss the study results:

Download study

*GRAFIX Membrane cannot save lives and instead may have an indirect effect on mortality