REGRANEX gel is the first and only FDA-approved recombinant platelet-derived growth factor (PDGF) therapy for diabetic neuropathic ulcers

Endogenous PDGF is the trigger that initiates healing by attracting repair cells to wounds7

Platelet-derived growth factor (PDGF) works to

  • Stimulate fibroblast proliferation to increase growth of granulation tissue6
  • Increase the rate of re-epithelialization and revascularization6
  • Promote collagen production6

Find out more about the four stages of healing.

Hemostasis

  • Clotting
  • Vascular
    response

Platelets release PDGF to initiate the chemotaxis of neutrophils, macrophages, smooth muscle cells, and fibroblasts.7

Inflammation

  • Inflammation

Neutrophils remove foreign material, bacteria and nonfunctional host cells, and damaged matrix components from the wound site.7

Fixed tissue monocytes are activated to become wound macrophages that release PDGF and TGF-ß to further attract fibroblasts and smooth muscle cells to the wound. Macrophages are also responsible for removing nonfunctional host cells, bacteria, damaged matrix, and foreign debris from the wound site.7

Proliferation

  • Ephithelial
    healing
  • Contraction
  • Scar
    formation

Fibroblasts, recruited by PDGF, produce the new matrix needed to restore structure and function to the injured tissue. Fibroblasts attach to the cables of the provisional fibrin matrix and begin to produce collagen7

Remodeling

  • Scar
    remodeling

This phase is characterized by continued synthesis and degradation of the extracellular matrix components to establish a new skin matrix.7

Collagenase enzymes act on collagen to break it into smaller fragments. The extracellular matrix is then rebuilt to provide strength to mature scar tissue.7

Because REGRANEX gel is indicated for diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond, it is not indicated for use during this phase of healing.5

The impact of diabetic foot disease

Diabetic foot disease affects millions around the world and the prevalence is increasing in the US.18,19,21

Review prevalence data
Do you treat wounds like these?

See how treatment with REGRANEX gel along with good ulcer care helped two diabetic foot ulcers completely heal.

Review case studies
Breaking the cycle of inflammation10

Debridement helps remove the necrotic burden in diabetic foot ulcers and other types of chronic wounds.*

*Reference: Enoch S, Harding K. Wound bed preparation: the science behind the removal of barriers to healing. Wounds. 2003;15:213-229.

Important Safety Information

REGRANEX gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply when used as an adjunct to, and not a substitute for, good ulcer care practices.

Malignancies distant from the site of application have been reported in both a clinical study and in posmarketing use. The benefits and risks of REGRANEX gel treatment should be carefully evaluated before prescribing in patients with known malignancy.

See complete prescribing information for more details.

Show References

  1. Moulik PK, Mtonga R, Gill GV. Amputation and mortality in new-onset diabetic foot ulcers stratified by etiology. Diabetes Care. 2003;26:491-494.
  2. Armstrong DG, Wrobel J, Robbins JM. Guest editorial: are diabetes-related wounds and amputations worse than cancer? Int Wound J. 2007;4:286-287.
  3. American Cancer Society. Cancer Facts & Figures 2014. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2014/cancer-facts-and-figures-2014.pdf. Accessed May 5, 2017.
  4. Wieman TJ, Smiell JM, Su Y. Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase III randomized placebo-controlled double-blind study. Diabetes Care. 1998;21:822-827.
  5. REGRANEX gel Prescribing Information.
  6. Heldin CH, Westermark B. Mechanism of action and in vivo role of platelet-derived growth factor. Physiol Rev. 1999;79:1283-1316.
  7. Diegelmann RF, Evans MC. Wound healing: an overview of acute, fibrotic and delayed healing. Front Biosci. 2004;9:283-289.
  8. Guo S, DiPietro LA. Factors affecting wound healing. J Dent Res. 2010;89:219-229.
  9. Snyder RJ, Hanft JR. Diabetic foot ulcers—effects on quality of life, costs, and mortality and the role of standard wound care and advanced-care therapies in healing: a review. Ostomy Wound Manage. 2009;55:28-38.
  10. Edmonds M, Foster AV, Vowden P. Wound bed preparation for diabetic ulcers. In: Moffatt C, ed. European Wound Management Association (EWMA). Position Document: Wound Bed Preparation in Practice. London, England: MEP Ltd; 2004:6-11.
  11. Steed DL, Attinger C, Colaizzi T, et al. Guidelines for the treatment of diabetic ulcers. Wound Repair Regen. 2006;14:680-692.
  12. Snyder RJ, Kirsner RS, Warriner RA III, Lavery LA, Hanft JR, Sheehan P. Consensus recommendations on advancing the standard of care for treating neuropathic foot ulcers in patients with diabetes. Ostomy Wound Manage. 2010;56(4 Suppl):S1-S24.
  13. Papanas N, Maltezos E. Benefit-risk assessment of becaplermin in the treatment of diabetic foot ulcers. Drug Saf. 2010;33:455-461.
  14. Falanga V. Wound bed preparation: science applied to practice. In: Moffatt C, ed. European Wound Management Association (EWMA). Position Document: Wound Bed Preparation in Practice. London, England: MEP Ltd; 2004:2-5.
  15. Delamater AM. Improving patient adherence. Clin Diabetes. 2006;24:71-77.
  16. Lantis JC II, Boone D, Gendics C, Todd G. Analysis of patient cost for recombinant human platelet-derived growth factor therapy as the first-line treatment of the insured patient with a diabetic foot ulcer. Adv Skin Wound Care. 2009;22:167-171.
  17. Data on file. Smith & Nephew. October 2012.
  18. Frykberg RG, Zgonis T, Armstrong DG, et al; American College of Foot and Ankle Surgeons. Diabetic foot disorders: a clinical practice guideline (2006 revision). J Foot Ankle Surg. 2006;45(5 Suppl):S1-S66.
  19. Huang ES, Basu A, O’Grady M, Capretta JC. Projecting the future diabetes population size and related costs for the US. Diabetes Care. 2009;32:2225-2229.
  20. Boulton AJ. The diabetic foot: grand overview, epidemiology and pathogenesis. Diabetes Metab Res Rev. 2008;24 Suppl 1:S3-S6.
  21. International Working Group on the Diabetic Foot. Time to act. Available at: https://www.worlddiabetesfoundation.org/sites/default/files/Diabetes%20and%20Foot%20care_Time%20to%20act.pdf. Accessed May 9, 2017.
  22. Adeshara KA, Diwan AG, Tupe RS. Diabetes and complications: cellular signalling pathways, current understanding and targeted therapies. Curr Drug Targets. 2016;17:1309-1328.
  23. Kirsner RS. The standard of care for evaluation and treatment of diabetic foot ulcers. The University of Michigan Medical School. The University of Michigan Health System’s Educational Services for Nursing. Barry University School of Podiatric Medicine 2010. Available at: http://www.barry.edu/includes/docs/continuing-medical-education/diabetic.pdf. Accessed May 5, 2017.

Important Safety Information: REGRANEX gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply when used as an adjunct to, and not a substitute for, good ulcer care practices.

Important Safety Information: REGRANEX gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply when used as an adjunct to, and not a substitute for, good ulcer care practices.