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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
Author(s) -
Kirsner Robert S.,
Sabolinski Michael L.,
Parsons Nathan B.,
Skornicki Michelle,
Marston William A.
Publication year - 2015
Publication title -
wound repair and regeneration
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.847
H-Index - 109
eISSN - 1524-475X
pISSN - 1067-1927
DOI - 10.1111/wrr.12332
Subject(s) - medicine , amnion , hazard ratio , diabetic foot , confidence interval , surgery , proportional hazards model , wound healing , diabetes mellitus , pregnancy , fetus , genetics , biology , endocrinology
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 cm 2 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 cm 2 and 4.4 months for BLCC and 5.2 cm 2 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).