West of Ireland Diabetes Foot Study:
Epidemiology, Cost, Feasibility and Implications for Clinical
Practice and Policy
Dr Sean Dinneen, Principal Investigator
Laura Kelly, Research Podiatrist
Lorna Hurley, Project Manager
Introduction
• 15% of people with diabetes develop foot ulceration
• Risk factors:
– diabetic neuropathy
– structural foot deformity
– peripheral arterial disease
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Complications: infection, osteomyelitis, gangrene
5% to 15% with diabetic foot ulcers require amputation
Lack of research on the diabetes foot in Ireland
In-patient expenditure for diabetic foot ulceration =
€23,500 per patient (Smith et al, 2005)
Multidisciplinary Team Management
of Diabetes Foot Ulcers
General Practitioner
& Practice Nurse
Diabetes Specialist Team
(Medical & Nursing)
Public Health Nurses
Foot Ulcer Management
Hospital Podiatrist
Orthopaedic Specialists
Community Podiatrists
Vascular Specialists
Plaster technicians
Physiotherapists
Orthotists
• Many foot related complications can be prevented
• International Guidelines recommend annual screening
for diabetes foot complications
• 1998 study in WHB: great variation in the
frequency of foot checks by GP’s
• HSE: greater emphasis on Primary Care Management
of chronic diseases
• Need for clear guidance and training for health
professionals involved in diabetes care
Background: Pilot Study
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Pilot Study carried out in 2006
Patients recruited from one city-practice
30 patients attended for screening (44%)
Neurological Assessment
– NDS (Vibration, Temperature, Blunt/sharp sensation,
Ankle Jerk)
– 10g monofilament
• Vascular Assessment
– Palpation of Pedal Pulses
– ABPI
Results of Pilot Study
Table 2:
Test Results
Normal
% (n)
Abnormal
% (n)
Missing
or Invalid
Monofilament
70% (21)
30% (9)
0
NDS
60% (18)
40% (12)
0
Pulses
77% (23)
13% (7)
0
ABPI
73% (22)
0
27% (8)
Figure 1: Monofilament testing
Figure 2: ABPI testing
Pilot Study Conclusions
• A significant number of patients have
abnormalities detectable on a simple panel of foot
screening tests
• These tests are relatively easy to perform
• A standardised panel of Foot Screening Tests
could easily incorporated into the patients annual
review visit in General Practice
• A larger study is required to establish the true
prevalence of diabetes foot complications
Diabetes Foot Study
Research Team
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Dr Sean Dinneen, Principal Investigator
Laura Kelly, Research Podiatrist
Lorna Hurley, Project Manager
Dr Liam Glynn, GP
Dr Caroline McIntosh, Head of Podiatry, NUIG
Paddy Gillespie, Health Economist, NUIG
Trish Godwin, Chiropody Manager, Galway PCCC
John Newell, Statistician, NUIG
Dr Adam Garrow, University of Salford
The West of Ireland Diabetes
Foot Study:
Epidemiology, Cost, Feasibility and
Implications for Clinical Practice and Policy
Aims
• To establish a set of easy to use measures for
screening for diabetes foot complications
• To apply these measures to a large sample of
patients attending local general practices
• To recruit medical and nursing staff from these
practices to become skilled in performing diabetes
foot examinations
• To establish the prevalence of diabetes foot
complications in this population
• To determine the incidence and predictors of new
diabetic foot events at 18 months
Aims (continued)
• To determine the impact of foot complications on
Health Status, Quality of Life, Anxiety & Depression
• In all patients developing new foot ulcers:
– Establish the degree to which these patients used the health
service for the duration of their foot care episode
– Establish the cost of each foot care episode to the patient
and to the health service
Study Design
• Design:
– Longitudinal observational study
– Main Study: Foot Screening Study (est. n=560)
• baseline screening visit
• 18 month follow-up
– Sub-study: Foot Ulcer Cost Analysis
• Prospective gathering of cost data
Recruitment
Practice Recruitment
• Recruitment of General Practices (Nov‘08–Apr ‘09)
• Letters of ‘Invitation to participate’ sent
• Practice meetings & presentations
• Training of Practice Nurses
Patient Recruitment
• Joint review of diabetes register and
inclusion/exclusion criteria
• Invitation letters to patients
• Practice-based clinics performed by the Practice
Nurse and Research Podiatrist
Overview of Screening Study
Baseline Visit
• Consent
• Questionnaires
• Foot Screening
- Vascular Assessment
- Neurological Assessment
- Plantar Pressure Assessment
• Foot Wound Alert Card
6 month & 12 months
• Wound Alert reminder letters
Follow-up visit (18 months)
• Questionnaires
• Foot Screening Tests (as above)
Screening Study: Issues Arising
• Choice of Questionnaires
– Generic (SF-12 v EUroQoL)
– Disease Specific (ADDQoL v WB-Q28)
• Choice of Vascular Assessment
– Pulse palpation ± Doppler Waveform ± ABPI / Toe
Pressure
– Training / skill issue
• Assessing Deformity
– Observational tests - too subjective
Plantar Pressure Assessment
PressureStat®
Overview of
Cost Analysis Sub-Study
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Podiatric review of all foot wounds (& photo)
Foot Ulcer Grading (Texas Classification System)
NeuroQol questionnaire
Support from Health Economists
– Patient Resource Items
• Health Economic Questionnaire
– Healthcare Resource Items:
• Hand-held log of all health service contact
• Review of all medical notes
Cost Analysis: Issues Arising
• Small numbers: estimated 2% incidence
• Potential for missing some ulcers due to:
– Failure of patients to report
– Failure of health professionals to report
– Uncertainty as to the diagnosis of an ulcer e.g.
“ when does a wound become an ulcer?”
• Potential for missing some health service
contact when calculating the Health Service
Resource Cost
• Unit-Cost Data is not readily available for some
outpatient visits
Progress to date
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REC Approval from ICGP and GUH
Awaiting approval of some amendments
8 practices recruited so far
Training day held in September for PN’s
Approximately 5 clinics booked (Nov-Dec)
Thank You!
Questions?