title: Reporting standards of studies and papers on the prevention and management of foot ulcers in diabetes: required details and markers of good quality.
abstract: The evidence base for many aspects of the management of foot ulcers in people with diabetes is weak, and good-quality research, especially relating to studies of direct relevance to routine clinical care, is needed. In this paper, we summarise the core details required in the planning and reporting of intervention studies in the prevention and management of diabetic foot ulcers, including studies that focus on off-loading, stimulation of wound healing, peripheral artery disease, and infection. We highlight aspects of trial design, conduct, and reporting that should be taken into account to minimise bias and improve quality. We also provide a 21-point checklist for researchers and for readers who assess the quality of published work.
authors.affiliation: Foot Ulcer Trials Unit, Department of Diabetes and Endocrinology, Nottingham University Hospitals Trust, Nottingham, UK. Electronic address: wjeffcoate@futu.co.uk.
authors.forename: William J
authors.initials: WJ
authors.lastname: Jeffcoate
authors.affiliation: Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands.
authors.forename: Sicco A
authors.initials: SA
authors.lastname: Bus
authors.affiliation: Derby Teaching Hospitals, National Health Service Foundation Trust, Derby, UK.
authors.forename: Frances L
authors.initials: FL
authors.lastname: Game
authors.affiliation: St George's Vascular Unit, St George's Hospital, London, UK; Department of Vascular Surgery, University of Bristol and Bristol Royal Infirmary, Bristol, UK.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Hinchliffe
authors.affiliation: Vice-Chancellors' Office, Cardiff University, Cardiff, UK.
authors.forename: Patricia E
authors.initials: PE
authors.lastname: Price
authors.affiliation: Maastricht University Medical Centre, Maastricht, Netherlands.
authors.forename: Nicolaas C
authors.initials: NC
authors.lastname: Schaper
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D017719:Diabetic Foot / Q000628:therapy*; D006801:Humans