Transitioning To Advanced Therapies For DFUs: Are Four Weeks And 50 Percent The Magic Numbers?

Start Page: 46

What One Study Reveals About A Bioengineered Skin Substitute And The Rate Of Healing Of Diabetic Foot Ulcers

In a prospective, randomized, multicenter study, Veves and colleagues analyzed 208 patients with diabetes who had full-thickness neuropathic ulcers, and observed the healing rates of diabetic neuropathic ulcers that were treated with Apligraf (Organogenesis) versus diabetic neuropathic ulcers treated with saline-moistened gauze.10 At baseline, the two groups were similar in regard to demographics, the type and duration of diabetes, and ulcer size and duration. The Apligraf group was comprised of 112 patients and there were 96 patients in the control group, which utilized saline-moistened gauze as treatment. Both groups received periodic debridement and offloading in addition to the respective treatment for their group.

The researchers analyzed 162 patients at the end of the study. The rate of healing was higher among those who had Apligraf applied every week than those who received saline moistened gauze. At the 12-week follow-up visit, 63 (56 percent) Apligraf-treated patients were completely healed in comparison to 36 patients (38 percent) treated with saline-moistened gauze. The average time to complete closure was 65 days for Apligraf, significantly lower than the 90 days researchers observed in the saline-moistened gauze group.

The rate of adverse reactions was similar between the two groups with the exception of osteomyelitis (3 percent in the Apligraf group versus 10 percent in the control group) and lower-limb amputations (6 percent versus 16 percent), both of which were less frequent in the Apligraf group. The study also noted the improvement in maceration, exudates and eschar in the Apligraf group from week 0 to week 12. Physicians should consider Apligraf for the management of diabetic foot ulcers that are resistant to the currently available standard of care.

54
Author(s): 
Chanel Houston, DPM, Samirah Mohammed, DPM, and Peter A. Blume, DPM, FACFAS

1. Fife C. Is HBOT cost-effective for diabetic foot ulcers? Podiatry Today. 2009:22(6):18-24.
2. Stillman R, Steinberg J. Current concepts in treating diabetic foot wounds. Podiatry Today. 2003:16(3):12-18.
3. Landsman A. Emerging concepts in healing diabetic foot ulcers. Podiatry Today. 2011;24(3):42-28.
4. Mulder G, Armstrong D, Seaman S. Standard, appropriate, and advanced care and medical-legal considerations: part one — diabetic foot ulcerations. Wounds. 2003;15(4):92–106.
5. Reiber GE, Lipsky BA, Gibbons GW. The burden of diabetic foot ulcers. Am J Surg. 1998; (176 2A Suppl):5S-10S.
6. Malay D, Margolis D, et al. The Incidence and risks of failure to heal after lower extremity amputation for the treatment of diabetic neuropathic foot ulcer. J Foot Ankle Surg. 2006;45(6):366–374.
7. Wound Ostomy and Continence Nurses Society (WOCN). Guideline for management of wounds in patients with lower-extremity arterial disease. Wound Ostomy and Continence Nurses Society, Glenview, IL. 2002.
8. Blume P, Walters J. et al. Comparison of negative pressure wound therapy using Vacuum-Assisted Closure with advanced moist wound therapy in the treatment of diabetic foot ulcers: a multicenter randomized controlled trial. Diabetes Care. 2008;31(4):631-636.
9. Martson WA, Hanft J, Norwood P, Pollak R. The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial. Diabetes Care. 2003;26(6):1701–1705.
10. Veves A, Falanga V, Armstrong DA, Sabolinski ML. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. Diabetes Care. 2001;24(2):290-295.
11. Robson MC, Payne WG, Garner WL, Biundo J, Giacalone VF, Cooper DM, Ouyang P. Integrating the results of phase IV (postmarketing) clinical trial with four previous trials reinforces the position that Regranex (becaplermin) gel 0.01% is an effective adjunct to the treatment of diabetic foot ulcers. J Appl Res. 2005;5:35–45.
12. Mannari RJ, Payne WG, Ochs DE, Walusimbi M, Blue M, Robson MC. Successful treatment of recalcitrant, diabetic heel ulcers with topical becaplermin (rh-PDGF-BB) gel. Wounds. 2002;14(3):116 –121.
13. Peters EJ, Lavery LA, Armstrong DG, Fleischli JG. Electric stimulation as an adjunct to heal diabetic foot ulcers: a randomized clinical trial. Arch Phys Med Rehabil. 2001;82(6):721–725.
14. Argenta LC, Morykwas MJ. Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg. 1997;38(6):563–576.
15. Sheehan P, Jones P. A percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete wound healing in a 120-week prospective trial. Diabetes Care. 2003;26(6):1879-1882.
16. Boulton A, Kirsner R, Vileikyte L. Neuropathic diabetic foot ulcers. N Engl J Med. 2004;351(1):48-55.
17. Snyder R, Cardinal M. A post-hoc analysis of reduction in diabetic foot ulcer size at 4 weeks as a predictor of healing by 12 weeks. Ostomy Wound Management. 2010;56(3):44-50.
18. Lavery L, Barnes S, et al. Prediction of healing for postoperative diabetic foot wounds based on early wound area progression. Diabetes Care. 2008;31 (1): 626-636.
19. American Diabetes Association. National Diabetes Fact Sheet 2011. http://www.diabetes.org/diabetes-basics/diabetes-statistics/
20. Centers for Disease Control and Prevention. National Diabetes Fact Sheet: General Information and National Estimates on Diabetes in the United States, 2011. Atlanta, GA, U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011. http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf
21. Ramsey SD, Newton K, Blough D, McCulloch DK, Sandhu N, Reiber GE, et al. Incidence, outcomes, and cost of foot ulcers in patients with diabetes. Diabetes Care. 1999;22(3):382-387.

image description image description


Post new comment

  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.

More information about formatting options

Image CAPTCHA
Enter the characters shown in the image.