title: Characterization of patients with diabetic foot disease presenting to an Irish Podiatry Centre: profiling suitability for entry to a clinical trial of advanced wound therapeutics.
abstract: BACKGROUND
  Diabetes mellitus, coined the 'Black Death of the Twenty-First Century', is associated with complications, including foot ulceration with potential loss of limb. There is a need for development of new wound therapies through completion of robust clinical trials.
  
  
  OBJECTIVE
  To profile demographics and wound characteristics of an Irish cohort with diabetes, forecast eligibility for entry to a clinical trial of advanced wound therapeutics, and adjust criteria to optimize eligibility for enrolment.
  
  
  METHODS
  A cross-sectional study of out-patients attending a Podiatry centre over 12 weeks was conducted. Information was collected through clinical assessment, including Neuropathy Disability Score and Ankle-Brachial Pressure Index. Ulcers were characterised as 'healing' or 'non-healing'; a 'healing' wound decreased by 30 % over the previous month, accomplished by retrospective analysis of files. Statistics, including binomial logistic regression and column analysis for eligibility assessment, were conducted.
  
  
  RESULTS
  Seventy-four participants were identified with a mean age of 67 (± 8.79) years. Non-healing DFU status correlated significantly with larger wound area (P = 0.013), infection (P = 0.009), and greater degrees of ischaemia (P = 0.015). The eligibility criteria were modelled after those proposed by the EU consortium project REDDSTAR. In this Irish population, these criteria limit eligibility to 1.4 %.
  
  
  CONCLUSIONS
  This research found an eligibility criterion of wound area 2-10 cm2for enrolment in a clinical trial of mesenchymal stromal cell therapy too restrictive. Extension of wound area to 1-10 cm2and the inclusion of neuro-ischaemic ulcers increased eligibility for enrolment from 1.4 to 20 %.
authors.affiliation: Discipline of Podiatric Medicine, College of Medicine, Nursing and Health Sciences, Aras Moyola, National University of Ireland, Galway, Republic of Ireland. a.mahon1@nuigalway.ie.|Regenerative Medicine Institute, Biosciences Research Building, National University of Ireland, Galway, Republic of Ireland. a.mahon1@nuigalway.ie.
authors.forename: A M
authors.initials: AM
authors.lastname: Mahon
authors.affiliation: Discipline of Podiatric Medicine, College of Medicine, Nursing and Health Sciences, Aras Moyola, National University of Ireland, Galway, Republic of Ireland.
authors.forename: C
authors.initials: C
authors.lastname: MacGilchrist
authors.affiliation: Discipline of Podiatric Medicine, College of Medicine, Nursing and Health Sciences, Aras Moyola, National University of Ireland, Galway, Republic of Ireland.
authors.forename: C
authors.initials: C
authors.lastname: McIntosh
authors.affiliation: Regenerative Medicine Institute, Biosciences Research Building, National University of Ireland, Galway, Republic of Ireland.|School of Medicine, College of Medicine, Nursing and Health Sciences, National University of Ireland, Galway, Republic of Ireland.
authors.forename: T
authors.initials: T
authors.lastname: O'Brien
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003430:Cross-Sectional Studies; D048909:Diabetes Complications / Q000209:etiology* / Q000473:pathology; D017719:Diabetic Foot / Q000209:etiology* / Q000473:pathology; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007494:Ireland; D008297:Male; D008875:Middle Aged; D011032:Podiatry / Q000379:methods*; D012189:Retrospective Studies; D014945:Wound Healing / Q000502:physiology*
keywords: Diabetes mellitus; Diabetic foot ulcer; Mesenchymal stromal cell; Podiatry