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INDUCE

Point of care tests to assist antibiotic prescribing decisions for diabetic foot ulcer infections

The lifetime risk of developing a diabetic foot ulcer (DFU) approaches 25% in the UK, resulting in direct costs for the care of DFUs at more than £250 million. Diagnosis of DFU infection remains entirely clinical with no objective test at the point of patient care to assist the clinician in antibiotic prescribing decisions.

C reactive protein (CRP), procalcitonin and calprotectin, are all markers of infection that are available as POCTs. However, the prognostic value

of a combination of these results has not yet been evaluated for DFU infection. This pilot study, aiming to recruit 110 adult DFU patients with either no infection or mild ulcer infection, will be based in community podiatry clinics and has 3 main aims:

1) To inform the feasibility of a subsequent RCT, particularly in terms of trial recruitment and use of the POCTs.

2) To determine the cut-off points for optimal negative predictive value (NPV) and positive predictive value (PPV) of a combination of the POCTs using a robust gold standard for ulcer infection. This would give proof of principle that a composite POCT can be safely used to inform the decision about infection/no infection at initial assessment in a community setting.

3) To develop an online educational tool for DFU infection and obtain feedback regarding its effectiveness from experienced clinicians and patients.

SEWTU Role

Full Co-ordination

Study Type

Pilot Study

Funder

Research for Patient & Public Benefit Wales

SEWTU Value

£140,430

Status

Open

Themes

NISCHR - DRN and Primary Care

SEWTU - Infections

Study Team

Professor Vincent Piguet , Cardiff University

Professor Keith Harding , Cardiff University

Professor Kerry Hood , Cardiff University

Dr Emma Thomas-Jones , Cardiff University

Dr Clive Gregory , Cardiff University

Scott Cawley, Cardiff and Vale University Health Board

Dr Nick Francis , Cardiff University

Tim Pickles , Cardiff University

Jane Lewis, Cardiff and Vale University Health Board

Trial Manager: Elinor Coulman , Cardiff University

Key data

Status
Running
Start date
April 1, 2014
End date
July 31, 2015
Grant value
£195,250
General enquiries
Dr Elinor Coulman
Chief investigators
Dr John Ingram