title: A prospective, randomised, controlled, multicentre clinical trial examining healing rates, safety and cost to closure of an acellular reticular allogenic human dermis versus standard of care in the treatment of chronic diabetic foot ulcers.
abstract: Acellular dermal matrices can successfully heal wounds. This study's goal was to compare clinical outcomes of a novel, open-structure human reticular acellular dermis matrix (HR-ADM) to facilitate wound closure in non-healing diabetic foot ulcers (DFUs) versus DFUs treated with standard of care (SOC). Following a 2-week screening period in which DFUs were treated with offloading and moist wound care, patients were randomised to either SOC alone or HR-ADM plus SOC applied weekly for up to 12 weeks. At 6 weeks, the primary outcome time, 65% of the HR-ADM-treated DFUs healed (13/20) compared with 5% (1/20) of DFUs that received SOC alone. At 12 weeks, the proportions of DFUs healed were 80% and 20%, respectively. Mean time to heal within 12 weeks was 40 days for the HR-ADM group compared with 77 days for the SOC group. There was no incidence of increased adverse or serious adverse events between groups or any adverse events related to the graft. Mean and median graft costs to closure per healed wound in the HR-ADM group were $1475 and $963, respectively. Weekly application of HR-ADM is an effective intervention for promoting closure of non-healing DFUs.
authors.affiliation: Department of Medical Education, Professional Education and Research Institute, Roanoke, VA, USA.
authors.forename: Charles M
authors.initials: CM
authors.lastname: Zelen
authors.affiliation: Department of Plastic Surgery, Brigham and Women's Hospital, Boston, MA, USA.
authors.forename: Dennis P
authors.initials: DP
authors.lastname: Orgill
authors.affiliation: Serena Group, Cambridge, MA, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Serena
authors.affiliation: Division of Plastic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Galiano
authors.affiliation: Strategic Solutions Inc., Cody, WY, USA.
authors.forename: Marissa J
authors.initials: MJ
authors.lastname: Carter
authors.affiliation: Lower Extremity Institute for Research and Therapy, Youngstown, OH, USA.
authors.forename: Lawrence A
authors.initials: LA
authors.lastname: DiDomenico
authors.affiliation: Shenandoah Lower Extremity Research, Troutville, VA, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Keller
authors.affiliation: General Surgery, Premier Surgical, Brick, NJ, USA.
authors.forename: Jarrod
authors.initials: J
authors.lastname: Kaufman
authors.affiliation: The Angiogenesis Foundation, Cambridge, MA, USA.
authors.forename: William W
authors.initials: WW
authors.lastname: Li
mesh_terms: D062088:Acellular Dermis / Q000191:economics*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002908:Chronic Disease / Q000191:economics* / Q000628:therapy*; D017719:Diabetic Foot / Q000191:economics* / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D017768:Skin, Artificial / Q000191:economics*; D059039:Standard of Care; D016896:Treatment Outcome; D014945:Wound Healing / Q000502:physiology*; D055815:Young Adult
keywords: Diabetic foot ulcers; Human acellular dermal tissue; Randomised controlled trial; Standard of care