Diabetic Foot Ulcer REsearch PlatFORM – DFU-REFORM

Research Question

Can we improve delivery of diabetic foot ulcer (DFU) research by developing a national research network with supportive infrastructure to deliver a cohort study with embedded trials to improve diagnosis of adverse features eg infection; improve treatment of DFUs; improve rates of recurrent ulcers once healed?

Background

It is estimated that 4.9million adults in the UK have diabetes and this number is increasing year-on-year. 25% of people with diabetes will develop a DFU in their lifetime. DFUs are associated with infection, hospitalisation, amputation and early mortality; negatively impact health related quality of life; cost NHS England ~£1billion per year in treatment.

Despite NICE guidance, healing rates for DFU at 12 weeks have remained relative unchanged over the decade with a 40% risk of recurrent ulceration at one year.

There is currently unprecedented NIHR funding for research in DFU care, but recruitment is challenging due to heterogeneity in care pathways, location of research teams away from DFU services and research inexperience of specialist podiatry teams. Therefore, despite large volumes of people with a DFU, only a small proportion are recruited into DFU studies.

Aims 1. Establish a DFU-REFORM NHS centre network and enhance podiatry capacity and capability.

2. Set-up a Platform Service User Group to facilitate PPIE and EDI to optimise involvement of all underserved communities

3. Assess the feasibility of a platform cohort of patients presenting with a new DFU including optimising: platform design; baseline and outcome dataset; statistical and health economic analysis; platform oversight. Methods

We will establish a national network of research ready DFU services by developing specialist podiatrists as PI/Associate PIs; supporting local podiatry services to draft business cases to integrate research personnel; supporting new podiatry PIs to optimise recruitment strategies and share learning across centres.

A Platform Service User Group will participate in developing an inclusion and diversity assessment and plan; patient information and communication development; and platform development. They will be provided with individualised research training and support.

We will explore a modified Trial Within Cohort (TWiC) (or Umbrella trial) design to deliver a cohort study of people presenting with a new DFU. This will provide contemporary data on DFU natural history and outcomes, inform trial designs, allow development of clinical prediction models and inform multi-state modelling. Platform baseline and outcome datasets will be developed, and feasibility of data collection will be assessed.

We will develop protocols for embedded trials to answer the research questions. A TWiC for diagnostic test strategy effectiveness and multi-arm, multi-stage interventional trials for DFU treatment and secondary prevention of DFU recurrence will be developed, including trial specific outcomes. Timelines for delivery

The national network, Service User Group and platform, including feasibility, will be delivered over 12 months from April 2023, with a platform HTA Stage 1 submission in November 2023 and Stage 2 application in February 2024. Anticipated impact and dissemination

This acceleration award will allow efficient, cost-effective delivery of DFU studies that have an impact on patient outcomes and NHS costs. Dissemination will be via presentations, peer review publications and social media.