REGRANEX gel helped to heal wounds an average of six weeks earlier than placebo gel.4

12.3* Weeks

Good ulcer care
+ REGRANEX gel

Good ulcer care
+
REGRANEX gel

vs

18.1* Weeks

Good ulcer care
+ placebo gel

Good ulcer care
+
placebo gel

*P=0.013

Study design: The efficacy and safety of REGRANEX gel were studied in 382 patients with type 1 or type 2 diabetes in a multicenter, double-blind, parallel-group, placebo-controlled trial. Patients had at least one full-thickness chronic ulcer of the lower extremity. After sharp debridement of the ulcer, patients were randomized to receive REGRANEX gel or placebo gel, in conjunction with good ulcer care, until complete wound closure was achieved for a maximum of 20 weeks. To assess rate of closure, study visits were scheduled weekly for Visits 2 and 6 and every other week after Visit 6.4

Greater incidence of complete closure at 20 weeks with REGRANEX gel4

50%*

Good ulcer care
+ REGRANEX gel

Good ulcer care
+
REGRANEX gel

vs

35%*

Good ulcer care
+ placebo gel

Good ulcer care
+
placebo gel

*P=0.007

Study design: The efficacy and safety of REGRANEX gel were studied in 382 patients with type 1 or type 2 diabetes in a multicenter, double-blind, parallel-group, placebo-controlled trial. Patients had at least one full-thickness chronic ulcer of the lower extremity. After sharp debridement of the ulcer, patients were randomized to receive REGRANEX gel or placebo gel, in conjunction with good ulcer care, until complete wound closure was achieved for a maximum of 20 weeks. To assess incidence of closure, the area of the ulcer was measured and the target ulcer was assigned a functional assessment score based on whether the wound was completely closed without drainage or need of dressing, or (100% closed with drainage and requiring a dressing).4

Formulated for healing

Therapy with REGRANEX gel initiates healing by attracting repair cells to revitalize wounds.7

Review the MOA
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
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.