THE CHALLENGE OF HEALING
STALLED DFUs IS REAL
YET FASTER HEALING IS CRITICAL

The challenge is REAL. Many factors make DFUs tough-to-heal. 
When deciding if your treatment is tough enough for DFUs, 
you may want to consider these factors:

Dysfunctional wound environment

Patient comorbidities

Patient noncompliance

DFUs ARE CHALLENGING TO HEAL 
DUE TO THE DYSFUNCTIONAL WOUND ENVIRONMENT

In stalled DFUs, abnormalities with the patient's cells, signaling molecules, and ECM are common:

Stalled DFUs need an intervention that can help address the dysfunctional environment.

Find out more about Dermagraft's bioactivity
ECM=extracellular matrix.

FIBROBLASTS PLAY A 
CRITICAL ROLE IN WOUND HEALING

  • Fibroblasts are present in the healthy healing wound from the late inflammatory phase until full epithelialization has occurred7,8,11,12
  • Within several days of injury, fibroblasts are attracted into the wound bed where they deposit collagen and ECM proteins, helping to build granulation tissue, which serves as a scaffold for angiogenesis8,12

Stalled DFUs need healthy fibroblasts to build granulation tissue and accelerate the healing process.7,12

Find out more about Dermagraft's living, human fibroblasts

Fibroblasts isolated from DFUs are probably senescent and show an impaired response to growth factors.7

PATIENTS WITH DFUs OFTEN HAVE SIGNIFICANT COMORBIDITIES THAT MAY AFFECT THEIR ABILITY TO HEAL13

57%

of patients with DFU
have a history of
microvascular
disease*

Retinopathy

Nephropathy

Neuropathy

42%

of patients with DFU
have a history of
macrovascular
disease*

Stroke

Myocardial infarction

Peripheral vascular disease

*Data from a US managed care population that included 6992 patients with diabetes, of which 205 patients had DFUs.

Stalled DFUs need an intervention that is proven to heal more DFU patients faster in the real-world setting.

Find out more about Dermagraft's real-world observational studies

PATIENTS' ADHERENCE TO SELF-CARE PRACTICES IS TYPICALLY LOW AND IMPACTS HEALING14

  • Patients frequently describe a loss of independence over basic activities of living and a disruption to their sense of self as a result of their DFU14
  • Many studies have shown that patients with DFUs are often noncompliant with offloading15-19
  • In a study examining DFU patient adherence to offloading with a removable cast walker (RCW), patients wore the device on 28% of their active time. Of the most adherent patients, the RCW was worn only 60% of their active time20

Stalled DFUs need an intervention that is proven to heal more DFUs faster—even when patients are not optimally offloaded.

Find out more about Dermagraft's randomized controlled trial required for FDA approval

FASTER HEALING OF DFUs IS CRITICAL
PATIENTS ARE AT RISK FOR SERIOUS COMPLICATIONS

Osteomyelitis increases the risk of amputation

Osteomyelitis is a common complication of DFUs. Approximately 10% to 15% of foot ulcers in diabetics will progress to osteomyelitis, which greatly increases the risk of amputation.21-23

Amputations are common and life-threatening

15% of DFUs
result in
lower extremity
amputation.24

Every 5 minutes
a lower limb amputation
occurs among
patients with diabetes.25

Patients with DFUs
or diabetes-related amputations
have 5-year mortality rates
worse than many common
types of cancers.26

47% of diabetes-related
amputations end in death.27

Stalled DFUs need an intervention that heals faster and helps avoid DFU complications.

Find out more about Dermagraft's evidence to heal patients faster and help avoid complications

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Please refer to the Dermagraft Directions for Use for complete prescribing information.

REFERENCES:

  1. Barrientos S, et al. Wound Repair Regen. 2008;16:585-601.
  2. Cook H, et al. J Invest Dermatol. 2000;115:225-233.
  3. Kim BC, et al. J Cell Physiol. 2003;195:331-336.
  4. Van de Berg JS, et al. Surg Clin North Am. 2003;83:509-520.
  5. Mendez MV, et al. J Vasc Surg. 1998;28(26):876-883.
  6. Wall IB, et al. J Invest Dermatol. 2008;128(10):2526-2540.
  7. Falanga V. Lancet. 2005;366:1736-1743.
  8. Hunt TK, et al. Adv Skin Wound Care. 2000;13(suppl 2):6-11.
  9. Werner S, et al. J Invest Dermatol. 2007;127:998-1008.
  10. Smith PC. Int J Low Extrem Wounds. 2006;5(3):160-168.
  11. Bainbridge P. J Wound Care. 2013;22(8):407-412.
  12. Broughton G, et al. Plast Reconstr Surg. 2006;117(Suppl): 12S-34S.
  13. McEwen LN, et al. J Diabetes Complications. 2013;27(6):588-592.
  14. Ploderer B, et al. JMIR Diabetes. 2018;3(4):e10105.
  15. Armstrong DG, et al. J Am Podiatr Med Assoc. 2001;91(9):451-455.
  16. Waaijman R, et al. Diabetes Care. 2013;36:1613-1618.
  17. Ehrmann D, et al. J Diabetes Sci Technol. 2018;12 (3):695-700.
  18. Crews RT, et al. Diabetes Care. 2016;39(8):1371-1377.
  19. Bus SA, et al. Diabetes Care. 2013;36(12):4109-4116.
  20. Armstrong DG, et al. Diabetes Care. 2003;26:2595-2597.
  21. Giurato L, et al. World J Diabetes. 2017;8(4);135-142.
  22. Uysal S, et al. Int Wound J. 2017;14(6): 1219-1224.
  23. Lipsky BA, et al. Diabetes Metab Res Rev. 2016;32(suppl 1):45-74.
  24. Snyder RJ, et al. Ostomy Wound Manage. 2010;56(suppl 4): S1-S24.
  25. Centers for Disease Control and Prevention. National diabetes statistics report, 2017. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf. Accessed March 7, 2020.
  26. Armstrong DG, et al. Int Wound J. 2007;4(4):286-287.
  27. Moulik PK, et al. Diabetes Care. 2003;26:491-494.