Volume 380, Issue 9846, Pages (September 2012)

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Volume 380, Issue 9846, Pages 977-985 (September 2012) Spray-applied cell therapy with human allogeneic fibroblasts and keratinocytes for the treatment of chronic venous leg ulcers: a phase 2, multicentre, double-blind, randomised, placebo-controlled trial Prof Robert S Kirsner, MD, Prof William A Marston, MD, Prof Robert J Snyder, DPM, Tommy D Lee, MSHS, D Innes Cargill, PhD, Dr Herbert B Slade, MD The Lancet Volume 380, Issue 9846, Pages 977-985 (September 2012) DOI: 10.1016/S0140-6736(12)60644-8 Copyright © 2012 Elsevier Ltd Terms and Conditions

Figure 1 Trial profile Initial screen failures were mostly attributable to non-qualifying wound size, failure to confirm the diagnosis with duplex doppler ultrasonography, and low serum pre-albumin concentration. ITT=intention-to-treat. *Voluntary discontinuation. †Excluding one patient who died of unrelated causes before starting study treatment. The Lancet 2012 380, 977-985DOI: (10.1016/S0140-6736(12)60644-8) Copyright © 2012 Elsevier Ltd Terms and Conditions

Figure 2 Wound area reduction and wound closure (A) Wound area reduction. (B) Complete closure. The Lancet 2012 380, 977-985DOI: (10.1016/S0140-6736(12)60644-8) Copyright © 2012 Elsevier Ltd Terms and Conditions

Figure 3 Cox proportional hazards analysis of wound healing The Cox proportional hazards model incorporates a comparison of healed versus open wounds across treatment groups at each of the weekly trial visits, with censoring of missing data. The HR is the likelihood of healing at any given point in time, by group, relative to the vehicle control group. CIs show the range of potential values. HR=hazard ratio. The Lancet 2012 380, 977-985DOI: (10.1016/S0140-6736(12)60644-8) Copyright © 2012 Elsevier Ltd Terms and Conditions