title: The efficacy and safety of Grafix(®) for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial.
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.
authors.affiliation: Department of Plastic Surgery, University of Texas Southwestern, Dallas, TX, USA.
authors.forename: Lawrence A
authors.initials: LA
authors.lastname: Lavery
authors.forename: James
authors.initials: J
authors.lastname: Fulmer
authors.forename: Karry Ann
authors.initials: KA
authors.lastname: Shebetka
authors.forename: Matthew
authors.initials: M
authors.lastname: Regulski
authors.forename: Dean
authors.initials: D
authors.lastname: Vayser
authors.forename: David
authors.initials: D
authors.lastname: Fried
authors.forename: Howard
authors.initials: H
authors.lastname: Kashefsky
authors.forename: Tammy M
authors.initials: TM
authors.lastname: Owings
authors.forename: Janaki
authors.initials: J
authors.lastname: Nadarajah
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017719:Diabetic Foot / Q000628:therapy*; D005109:Extracellular Matrix; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010920:Placenta; D011247:Pregnancy; D011446:Prospective Studies; D016038:Skin Transplantation; D017768:Skin, Artificial; D014945:Wound Healing / Q000502:physiology*
keywords: Diabetes; Infection; Stem cells; Ulcer