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.

Aims: 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 cm² for enrolment in a clinical trial of mesenchymal stromal cell therapy too restrictive. Extension of wound area to 1-10 cm² and the inclusion of neuro-ischaemic ulcers increased eligibility for enrolment from 1.4 to 20 %.

Keywords: Diabetes mellitus; Diabetic foot ulcer; Mesenchymal stromal cell; Podiatry.