Open AccessComparative effectiveness of a human fibroblast-derived dermal substitute and a viable cryopreserved placental membrane for the treatment of diabetic foot ulcers
Author(s) -
Michael L. Sabolinski,
John V. Capotorto
Publication year - 2019
Publication title -
journal of comparative effectiveness research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.567
H-Index - 23
eISSN - 2042-6313
pISSN - 2042-6305
DOI - 10.2217/cer-2019-0001
Subject(s) - medicine , hazard ratio , confidence interval , diabetic foot , surgery , fibroblast , cryopreservation , dermal fibroblast , granulation tissue , foot (prosody) , wound closure , proportional hazards model , wound healing , diabetes mellitus , embryo , biochemistry , chemistry , linguistics , philosophy , microbiology and biotechnology , in vitro , biology , endocrinology
Objective: To compare a human fibroblast-derived dermal substitute (HFDS) to a viable cryopreserved placental membrane (vCPM) for use in diabetic foot ulcers (DFUs). Methods: An electronic medical record database of 1622 refractory DFUs with areas 1–40 cm 2 was analyzed. Results: Cox estimates of wound closure for HFDS (1444 wounds) were significantly greater (p = 0.0002) by weeks 12 (31 vs 21%), 24 (55 vs 39%) and 36 (68 vs 51%) compared with vCPM (178 wounds). HFDS reduced the median time to wound closure by 55% compared with vCPM, (20 vs 36 weeks, p = 0.0002). HFDS also increased the probability of wound closure by 60% (hazard ratio = 1.60 [95% confidence interval, (1.25, 2.06)], p = 0.0002). Conclusion: HFDS improved time and frequency of wound closure in DFUs versus vCPM.