title: Comparative effectiveness of a bioengineered living cellular construct vs. a dehydrated human amniotic membrane allograft for the treatment of diabetic foot ulcers in a real world setting.
abstract: We evaluated the comparative effectiveness of a bioengineered living cellular construct (BLCC) and a dehydrated human amnion/chorion membrane allograft (dHACM) for the treatment of diabetic foot ulcers (DFUs). Using a wound care-specific electronic medical record database, we assessed real-world outcomes in 218 patients with 226 DFUs receiving treatment in 2014 at 99 wound care centers. The analysis included DFUs ≥1 and <25 cm2 with duration <=1 year and area reduction ≤20% in 14 days prior to treatment (N=163, BLCC; N=63, dHACM). The average baseline areas and durations were 6.0 cm2 and 4.4 months for BLCC and 5.2 cm2 and 4.6 months for dHACM, respectively. Patients treated with dHACM had more applications compared to those treated with BLCC (median 3.0 vs. 2.0) (p=0.003). A Cox model adjusted for key covariates including area and duration found the median time to closure for BLCC was 13.3 weeks compared to 26 weeks for dHACM, and the proportion of wounds healed were significantly higher for BLCC by 12 weeks (48% vs. 28%) and 24 weeks (72% vs. 47%) (p=0.01). Treatment with a bioengineered living cellular technology increased the probability of healing by 97% compared with a dehydrated amniotic membrane (hazard ratio = 1.97 [95% confidence interval 1.17, 3.33], p=0.01).
authors.affiliation: Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, Florida.
authors.forename: Robert S
authors.initials: RS
authors.lastname: Kirsner
authors.affiliation: Sabolinski LLC, Franklin, Massachusetts.
authors.forename: Michael L
authors.initials: ML
authors.lastname: Sabolinski
authors.affiliation: Organogenesis Inc., Canton, Massachusetts.
authors.forename: Nathan B
authors.initials: NB
authors.lastname: Parsons
authors.affiliation: Organogenesis Inc., Canton, Massachusetts.
authors.forename: Michelle
authors.initials: M
authors.lastname: Skornicki
authors.affiliation: Department of Surgery, Division of Vascular Surgery, University of North Carolina Medical School, Chapel Hill, North Carolina.
authors.forename: William A
authors.initials: WA
authors.lastname: Marston
mesh_terms: D064591:Allografts; D000650:Amnion / Q000637:transplantation*; D001684:Biological Dressings; D003890:Desiccation; D017719:Diabetic Foot / Q000473:pathology / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D023822:Tissue Engineering; D016896:Treatment Outcome; D014945:Wound Healing / Q000502:physiology*