David is an Associate Professor and Honorary Consultant Vascular Surgeon in Leeds, UK. He trained as a General and Vascular Surgeon in the Yorkshire region, UK and Adelaide, Australia. He was appointed to Leeds Teaching Hospitals NHS Trust as a Consultant Vascular Surgeon with interest in diabetic foot disease in 2010 and has developed the local MDT clinic, community foot protection team and research capacity locally since this time.

David has research interests in assessment of ischaemia and decision making around revascularisation and amputation; wound healing; early detection of infection. He was appointed as Associate Professor at University of Leeds in 2020 after being awarded a prestigious NIHR Advanced Fellowship to investigate diagnosis of diabetic foot osteomyelitis through the DOMINO-DFU study.

He is the Chief Investigator for the UK NIHR HTA funded MIDFUT and REFORM-DFU studies, Co-Investigator for the UK NIHR HTA funded CODIFI2 trial and chair of the Vascular Society of Great Britain and Ireland Diabetic Foot Research Specialist Interest Group. He is a member of both NICE and IWGDF guideline committees, including the recently published intersocietal PAD in diabetes guidelines. In addition, David has a keen interest in teaching with both regional and national roles in vascular surgery training.

Presentation at The SoTV/EWMA 2024 Conference, London

Experience, challenges and future in DFU platform trials/studies – MIDFUT, DOMINO-DFU & DFU-REFORM

Learning objectives

After attending this session, persons will be able to:

• To understand the burden associated with diabetic foot ulcers
• To understand then different designs of platform studies
• To appreciate the research delivery challenges specific to DFU studies
• To identify how platform study design can be developed in collaboration with patients and researchers to mitigate disease specific challenges

Abstract

Diabetes affects over 5million adults in the UK, 25% of whom will develop a diabetic foot ulcer (DFU) in their lifetime. Treatment of diabetes related foot ulcers costs NHS England over £1billion per year whilst the disease impacts of health-related quality of life and socioeconomics of patients. Outcomes for DFU are worse in areas of social deprivation, with associated under-representation in clinical trials, and there is a need for novel, efficient research approaches to address this.

Delivery of multi-centre trials in DFU diagnosis and treatment is challenging, with examples of NIHR funded studies under-recruiting or closing early because of this. Challenges in research delivery include a national lack of podiatry research capacity; DFU being a heterogenous population with small proportions being eligible for specific trials; labour associated with identifying and opening study sites for each individual study.

This presentation will discuss the design of 3 DFU studies:

• MIDFUT – a MAMS design looking at combinations of hydrosurgical debridement, negative pressure wound therapy, and decellularised cadaveric dermis graft for hard-to-heal DFUs
• DOMINO-DFU – an adapted TWiC for diagnosis of osteomyelitis in DFU
• DFU-REFORM – a proposed adapted TWiC platform for DFU intervention studies

It will also discuss the design and delivery considerations of the DFU-REFORM platform including the development of a DFU research network; enhancing national podiatry research capacity for DFU; selection of study interventions.