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DFD PRIMO

Diabetic Foot Disease – from prevention to improved patient outcomes

Diabetes mellitus, a disease associated with high blood sugars, can cause several complications that can directly affect the feet. A diabetic foot ulcer is an open wound or sore on the foot that is often slow to heal and can become easily infected. Infection can spread quickly in people with diabetes and unfortunately leg and/or foot amputation and early death are associated with diabetes and its related foot problems. Early recognition of foot problems and timely, appropriate, treatments are key for the prevention of serious foot problems in people with diabetes.

Clinical guidelines

Clinical guidelines advocate for preventative measure however there is little evidence in the area of prevention of foot problems in diabetes. To address this gap in the evidence and unmet clinical need the Health Research Board of Ireland and Irish Research Council are funding a programme of research that will focus on the prevention of foot complications in diabetes and new treatment options for people with foot ulcers to improve patient outcomes. The programme is called DFD PRIMO (diabetic foot disease, from prevention to improved patient outcomes) with a total investment of €1.7 million over 5 years to support seven PhD students in NUI Galway and UCC. The programme is led by Prof Tim O’Brien, Prof. Georgina Gethin, Prof James O’Gara and Prof Caroline McIntosh, all from NUI Galway.

Overall goal

The overall goal of the training programme will be to train a team of health care professionals from different health professions to PhD level in order to provide a strong evidence base for prevention and treatment options whilst improving the care of people with diabetes related foot problems. The aims of this programme are to increase the number of highly skilled future research leaders and support research of high quality that will positively impact public health and policy and be of immediate benefit to patients in the clinical setting. This level of funding and number of students working together on one topic area is quite unique in the area of diabetic foot disease and will go a long way in recognising NUI Galway as a world leading centre of excellence in wound healing and in diabetic foot disease.

Prevention, management and advanced treatment options

While the programme has a strong focus on prevention it also focuses on management of infection and advanced treatment options including stem cell therapies. The seven students are working with world leading experts in wound healing, diabetes, psychology and microbiology and are supported by a team of national and international supervisors and collaborators. While recognising that prevention is critical to avoiding the onset of an ulcer and subsequent complications, not all ulcers can be prevented so therefore advanced therapies are needed. Students are: John Ivory, Isha Sikri, Enda Naughten, Jennifer Palin, Lauren Connell, Michele Hanlon

Lauren Connell

Developing Health Professionals health literacy competencies to support patients in diabetes self-management.

Supervised by Dr Jane Sixsmith and Dr Yvonne Finn. 

The project aims to develop and assess the feasibility of an educational intervention to empower patients, at risk of diabetic foot ulceration occurrence or recurrence, to self-manage.

My background is in Podiatry, I graduated with my BSc Podiatric Medicine in 2019, and completed my MPhil in Podaitric Medicine in 2020. I am passionate about providing holistic patient care, as a researcher and a clinican.

Health literacy is an evolving concept whereby 1 in 4 Irish people have 'limited' health literacy, which impacts an individual's ability to comprehend health information and use that information to make informed decisions. My project aims to develop an education programme for health professionals in an attempt to improve health literacy skills and communicational competencies to facilitate for better patient-practitioner communication.

This project is funded by the Human Research Board. It is part of the Diabetic Foot Disease (DFD) from prevention to improved patient outcomes (Primo) CDA scholarship, in conjunction with HrB.

Michelle Hanlon

Developing an online psychological intervention that will aim to improve mood, reduce stress and promote wound healing in individuals with diabetic foot ulcer.

Supervisors: Prof. Brian McGuire, Prof. Caroline McIntosh and Dr. Claire MacGilchrist.

PhD Student: Michelle has a master's degree in Psychological Science from Trinity College Dublin and a Bachelor of Arts degree in Psychological studies and English from NUI Galway. Since graduating in 2016, Michelle has worked as a researcher in the School of Psychology in NUI Galway. During this time, she has been involved in a number of different projects that have examined the psychological impact of living with long-term conditions, factors that can influence quality of life and treatment adherence, and behavioural and self-management interventions for chronic disease.

Why this research is needed: It is important to examine the psychological impact of living with diabetic foot ulcer because health-related quality of life among people with diabetes and foot ulcers is much lower than in the general population and rates of depression are high. Psychological interventions have the potential to improve ulcer healing and prevent reappearance as they can provide behavioural techniques that will help people to cope with and adjust to living with a long-term condition and strategies that can help them to feel more in control of managing their health and well-being.

Funding: Health Research Board (HRB) Collaborative Doctoral Award

John Ivory

A Diagnostic Tool for Detection of Biofilm in Diabetic Foot Ulcers

Supervisors:  Dr. Georgina Gethin and Prof. James P. O'Gara.

Background: Biochemistry, Neuropharmacology, Wound Care, Evidence Synthesis 

Summary: Bacteria can exist as free-floating, single cells or as fixed, protected communities called biofilms.  These biofilms have been found in more than 60% of chronic wounds such as diabetic foot ulcers and they can be difficult to remove.  Biofilm infections can make skin ulcers difficult to treat and are associated with extended healing times.  Currently, detection of biofilms is a complex process and requires sophisticated laboratory equipment.  The aim of this project is to determine the possibility of developing a simple diagnostic tool composed of easily observed clinical signs and symptoms that can be used to detect biofilm at the bedside. 

Importance: Such a tool would have the potential to streamline treatment choices/strategies for non-healing diabetic foot wounds and reduce unnecessary use of topical antimicrobials

Funding: Irish Research Council (IRC) 

Enda Naughten

Implementing the HSE Model of Care for the Diabetic Foot with community nurses.

Supervisors: Dr. Georgina Gethin, Prof. Timothy O’Brien and Dr. Martina Giltenane

Background: I have worked as a nurse for the past twenty years in a variety of clinical settings. I spent ten years in the acute hospital sector in critical care and as a clinical nurse manager.  I then moved to community nursing and worked as a Public Health Nurse and an Assistant Director of Public Health Nursing.  During my career I encountered diabetic patients with diabetic foot disease at various stages of their journey with the disease.

Research: My research will involve working with our community nursing partners to devise an implementation strategy for the HSE Model of Care for the Diabetic Foot.  The research will look at ways to ensuring that community nurses have the skills and guidelines to provide a quality service in a timely manner to diabetic patients with regards to foot care.  This will involve identifying, treating and onward referral of these patient to further services as necessary.

Why it is important:  Community nurses work with all sectors of the Irish population. They play a vital role in promoting the health of the communities they work in.  Ensuring they have the skills and information to provide the best care to diabetic patients will be an important part of improving the care for diabetic patients in Ireland.

Funding: Health Research Board (HRB)

Jennifer Pallin

Combined diabetic foot and retinal screening: a novel approach to early detection of complications

Supervisors: Dr. Claire Buckley (UCC), Prof. Sean Dinneen (NUI Galway), & Prof. Patricia Kearney (UCC)

Researcher Background: Jennifer has a B.Sc. (Hons) in Podiatry from NUI Galway, a Masters of Public Health (MPH) from UCD and five years’ experience working as a Podiatrist for the HSE.

Explanation of the research: Jennifer’s research will investigate the feasibility of combining diabetic foot screening with retinopathy (eye) screening to allow for earlier identification of foot complications associated with diabetes (e.g., loss of feeling in the feet, reduced blood flow to the feet).

Why the project is important: Individuals diagnosed with diabetes can develop problems with both their eyes and feet which may result in loss of sight and lower-limbs. Both vision loss and lower-limb loss are preventable through early finding of complications and timely referral to the right prevention services (i.e., ophthalmology for eyes and podiatry for feet).

The Diabetic RetinaScreen programme provides free diabetic retinopathy screening to those diagnosed with diabetes. Currently, annual diabetic foot screening is recommended but there is no national screening programme providing this, meaning many people do not receive an annual foot screening. This places people with diabetes at an increased risk of diabetic foot ulceration. Through her research, Jennifer’s goal is to improve foot health outcomes for all people with diabetes by finding out if it is feasible to screen for signs of diabetic foot problems at the RetinaScreen visit.

Funding: Health Research Board Ireland (Scholar on the HRB-Funded SPHeRE Programme)

Isha Sikri

Manufacture of an Allogeneic Advanced Therapy Medicinal Product for Use in Diabetic Foot Ulcers.

Supervisors: Prof. Timothy O’Brien, Prof. Caroline McIntosh, Prof. Gerard O’Connor and Prof. Yury Rochev

Background: I am a highly driven researcher in regenerative medicine with experience in cell culture, molecular biology laboratory techniques, and tissue engineering. I worked as a Research assistant on CALIN project in Prof. Frank Barry’s lab at NUIG. I completed my Masters in Regenerative Medicine in 2019 from National University of Ireland Galway and was a recipient of Sir Peter Freyer Special Merit Scholarship.

About the project and its importance: Non-healing diabetic foot ulcers (DFU) are a common prelude to lower extremity amputation in patients with diabetes mellitus and given the increasing prevalence of this condition is likely to remain a significant burden for patients and the healthcare system in the future. The question to be addressed in this study is whether a universal cell therapy and biomaterial construct can be manufactured under Good Manufacturing Practices (GMP) conditions suitable for use in large numbers of patients with non-healing DFU. The product will be based on mesenchymal stromal cells (MSC) derived from umbilical cord and collagen as these components have therapeutic potential in non-healing DFU. However, currently available therapeutic constructs have challenges for large scale off the shelf use and heterogeneity of starting cell material results in significant regulatory challenges. In this project, we will establish a collaboration between researchers from health economics, physics, clinical medicine and podiatry in order to apply advances in laser physics to the development of a cost-effective cell therapy product.

Funding Source: Health Research Board (HRB)