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

International Wound Journal - Tập 11 Số 5 - Trang 554-560 - 2014
Lawrence A. Lavery1, James Fulmer2, Karry Ann Shebetka3, Matthew Regulski4, Dean Vayser5, David L. Fried6, Howard Kashefsky7, Tammy M. Owings8, Janaki Nadarajah9
1Department of Plastic Surgery, University of Texas Southwestern, Dallas, TX, USA.
2River City Clinical Research, Jacksonville, FL, USA
3Clinical Trials of Texas San Antonio TX USA
4Ocean County Foot and Ankle, Toms River, NJ, USA
5ILD Research Center, Carlsbad, CA, USA
6Omega Medical Research Warwick RI USA
7University of North Carolina at Chapel Hill, Chapel Hill, NC USA
8Cleveland Clinic, Cleveland, OH, USA
9Aiyan Diabetes Center, Evans, GA, USA

Tóm tắt

AbstractIn 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.

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International Wound Journal

Tập 11 Số 5

554-560

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