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Randomized Controlled Trial
. 2014 Oct;11(5):554-60.
doi: 10.1111/iwj.12329. Epub 2014 Jul 21.

The efficacy and safety of Grafix(®) for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial

Lawrence A Lavery  1 , James Fulmer, Karry Ann Shebetka, Matthew Regulski, Dean Vayser, David Fried, Howard Kashefsky, Tammy M Owings, Janaki Nadarajah; Grafix Diabetic Foot Ulcer Study Group
Collaborators, Affiliations
Randomized Controlled Trial

The efficacy and safety of Grafix(®) for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial

Lawrence A Lavery et al. Int Wound J. 2014 Oct.

Abstract

In a randomised, controlled study, we compared the efficacy of Grafix(®) , a human viable wound matrix (hVWM) (N = 50), to standard wound care (n = 47) to heal diabetic foot ulcers (DFUs). The primary endpoint was the proportion of patients with complete wound closure by 12 weeks. Secondary endpoints included the time to wound closure, adverse events and wound closure in the crossover phase. The proportion of patients who achieved complete wound closure was significantly higher in patients who received Grafix (62%) compared with controls (21%, P = 0·0001). The median time to healing was 42 days in Grafix patients compared with 69·5 days in controls (P = 0·019). There were fewer Grafix patients with adverse events (44% versus 66%, P = 0·031) and fewer Grafix patients with wound-related infections (18% versus 36·2%, P = 0·044). Among the study subjects that healed, ulcers remained closed in 82·1% of patients (23 of 28 patients) in the Grafix group versus 70% (7 of 10 patients) in the control group (P = 0·419). Treatment with Grafix significantly improved DFU healing compared with standard wound therapy. Importantly, Grafix also reduced DFU-related complications. The results of this well-controlled study showed that Grafix is a safe and more effective therapy for treating DFUs than standard wound therapy.

Keywords: Diabetes; Infection; Stem cells; Ulcer.

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Figures

Figure 1
Figure 1
Kaplan–Meier analysis of probability of 100% closure for Grafix versus control.
See this image and copyright information in PMC

References

    1. Guariguata L, Whiting D, Weil C, Unwin N. The International Diabetes Federation diabetes atlas methodology for estimating global and national prevalence of diabetes in adults. Diabetes Res Clin Pract 2011;94:322–32. - PubMed
    1. Centers for Disease Control and Prevention (CDC) . 2007 National Diabetes Fact Sheet. Atlanta: CDC, 2008.
    1. American Diabetes A. Economic costs of diabetes in the U.S. in 2012. Diabetes Care 2013;36:1033–46. - PMC - PubMed
    1. Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA 2005;293:217–28. - PubMed
    1. Kantor J, Margolis DJ. Treatment options for diabetic neuropathic foot ulcers: a cost‐effectiveness analysis. Dermatol Surg 2001;27:347–51. - PubMed

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