Multifactorial strategies for the prevention of the risks of ulceration in patients affected by diabetic foot: a no-profit, multicentre, clinical trial protocol

Introduction

Diabetes mellitus is a global epidemic affecting hundreds of millions of people worldwide. The diabetic foot is among the most serious complications, and it is estimated that between 15 and 25% of patients with diabetes mellitus develop ulcers during their lifetime. The costs for the treatments of foot ulcerations are enormous, and thus prevention and early personalised treatments are a priority. Many traditional clinical and metabolic analyses have been performed, but these should now be supported by modern specific multi-instrumental measurements.

Methods and analysis

This is a no-profit, multicentre national study aimed at the prevention of complications in the diabetic foot. It is an interventional clinical trial, without medications or medical devices, involving two populations of patients with diabetes mellitus type-2. A first population has no previous history of foot ulceration but has a moderate ulcerative risk (International Working Group on the Diabetic Foot (IWGDF) grade 2); this will receive state-of-the-art clinical assessments and metabolic analyses in one centre, together with thorough biomechanical and functional analyses in a second centre and advanced biological and biochemical analyses in a third centre. A second population is affected by diabetic foot, had foot ulcers (IWGDF grade 3) but these must have been resolved for at least 6 months; in the centre in which they are recruited, they will receive state-of-the-art clinical assessments and metabolic analyses, together with advanced biological and biochemical analyses. Internationally established scores will be used in the three centres. Comparison of all these measurements between the two populations is performed at baseline (T0) and at 12-month follow-up (T1). Biomechanical analyses include multi-segment foot kinematics with stereophotogrammetry, plantar pressure with instrumented platforms and also 3D reconstructions of foot bones, tissues and calcifications from most modern CT scans in weight-bearing.

The primary objective is to compare the clinical and metabolic condition together with the biological and biochemical biomarkers in the two populations. Secondary objectives are (a) creation of a database for reference on metabolic conditions and structural and dynamic alterations of the diabetic foot in correlation with risk of ulceration; (b) comparison of the measurements at T0 and T1 of all the measurements; and (c) analysis of possible correlation between biomechanical parameters and the onset of ulceration in the first population. In other words, possible novel biomechanical and biochemical based biomarkers for the risks of ulceration are searched.

Ethics and dissemination

The present study wants to contribute in a possible future limitation of the incidence of foot ulcerations in patients with diabetes mellitus, through careful screenings, risk stratifications and thorough monitoring. The study finally combines traditional assessments with modern multi-instrumental measuring techniques being supported by a multidisciplinary investigative approach.

The present study protocol has been recently approved by the local ethical committees (‘Comitato Etico di Area Vasta Emilia Centro – AVEC’, and ‘Comitato Etico della Romagna – CEROM’). Written informed consent will be collected for all the participants. Findings of this study will be disseminated through peer-reviewed publications and conference presentations, as always and frequently done by the present authors.

Registration details

Clinical study ‘Strategie multifattoriali per la prevenzione dei rischi di ulcerazione in pazienti affetti da piede diabetico’, prot. DARE-DiaFoot, promoted by Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Ortopedico Rizzoli: