Lavery LA, Fulmer J, Shebetka KA, Regulski M, Vayser D, Fried D, Kashefsky H, Owings TM, Nadarajah J, Grafix Diabetic Foot Ulcer Study Group., et al.
International wound journal. Date of publication 2014 Oct 1;volume 11(5):554-60.
1. Int Wound J. 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.
Lavery LA(1), Fulmer J, Shebetka KA, Regulski M, Vayser D, Fried D, Kashefsky H,
Owings TM, Nadarajah J; Grafix Diabetic Foot Ulcer Study Group.
Collaborators: Grant D, Lowhorn M, Hendrick T, Streja D, Friedlander G, Goldman
D, Budny A, Treadwell T, Ware D, Kerzner M, Gordon I.
Author information:
(1)Department of Plastic Surgery, University of Texas Southwestern, Dallas, TX,
USA.
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.
© 2014 The Authors. International Wound Journal published by Medicalhelplines.com
Inc and John Wiley & Sons Ltd.
DOI: 10.1111/iwj.12329
PMID: 25048468 [Indexed for MEDLINE]
