Will DINGO unlock diabetic foot management in Australasia? - DEFIANZ: Diabetic Foot Infections Australia New Zealand
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Will DINGO unlock diabetic foot
management in Australasia?
DEFIANZ: Diabetic Foot Infections Australia
New Zealand
Dr Rob Commons
Ballarat Health Services & Menzies School of Health Research
DEFIANZ • Interest group in diabetic foot infections formed as part of the Australasian Society of Infectious Diseases (ASID) Clinical Research Network • Formed 4 years ago • Multidisciplinary
Paterson et al, MJA, 2013
By 2033, 3.5 million Australians expected to have diabetes
3.4% of Australian diabetic patients had a current foot ulcer in 2015
(2 fold rise from 2009)
Diabetic foot ulcers become infected in approximately 50% of cases
>3% of inpatients affected by DFI
19%
Scenario 1: Scenario 2:
106 respondents gave 82 unique regimens 101 respondents gave 76 unique regimens
ID consults relating to
diabetic foot infections
Current management Despite the presence of guidelines, our practice is varied. Perhaps because: • Guidelines lack specificity • Few randomised clinical trials • Patients are very heterogeneous • Progress is hard to assess • Outcomes are serious and poor • ‘Need to do something’
DINGO: Diabetic foot INfection lonGitudinal Outcome study
? Impact of total antibiotic duration
Objectives
? impact of IV antibiotic duration
? oral antibiotics instead of IV
? impact of antibiotic spectrum
1. To describe the management and outcomes of diabetic foot
infections and identify areas of equipoise between
antimicrobial strategies that could be addressed in future
targeted clinical trials
2. To develop a collaborative network of clinicians; refine data collection
? Impactand
tools and methodology of total antibiotic
collect baselineduration
pilot data for future trials
? impact
3. To evaluate diabetic of IV
foot antibiotic
severity toolsduration
in relation to outcome
? oral antibiotics instead of IV
(PEDIS/WIFI/COCLASSTI)
? impact of antibiotic
4. To create a DOOR/RADAR outcome spectrum
framework for assessment of
diabetic foot infections
Study design
Screening
Enrolment
• Multicentre
• Observational study
• Informed consent Follow up as per clinical
management
• Paper and REDCap questionnaire - ~ 6 weeks
- ~ 3 months
• QOL survey (EQ-5D-5L)
• Follow up at usual review
Final outcomes at 6 months
• Six month follow up - Patient review
- +/- telephone call
- +/- GP call
Inclusion criteria • Adult inpatients or outpatients • Type 1 or 2 diabetes mellitus • New onset foot infection • Mild, moderate or severe • Present
Outcomes • Healing of index ulcer at six months • Minor and major amputation at six months • Resolution of infection at six weeks, three months and six months • Re-ulceration at six months • Death at six months • Global function and quality of life at six months • Antibiotic complication at six months • Antibiotic free days
Mid Nov 2017: Late 2018: End 2020:
• Complete pilot
• Finalise study sites
Commence Complete
• Finalise REDCap enrolment follow-up
Early 2018: Mid 2020:
Submit Complete
ethics enrolmentSites
• 24 sites
• 16 sites enrolling
• Closed to new sitesCumulative patients
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reInterim results
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Characteristic Number (%)
20
Age, years (mean, sd) 59.7 (12.2)
Sex
15
Number
Male 110 (77.5)
Female 32 (22.5)
10
Severity grade (PEDIS)
Mild 33 (23.1)
5
Moderate 86 (60.1)
Severe 24 (16.8)
0
20 30 40 50 60 70 80 90 100
AgeInterim results
Outcome Total Mild Moderate Severe
n=44
Healed 26 (59.1%) 6 (66.7%) 19 (70.4%) 1 (12.5%)
Not healed 10 (22.7%) 3 (33.3%) 3 (11.1%) 4 (50.0%)
Minor amputation 6 (13.6%) 0 (0) 4 (14.8%) 2 (25.0%)
Death 1 (2.3%) 0 (0) 1 (3.7%) 0 (0)
LTFU 1 (2.3%) 0 (0) 0 (0) 1 (12.5%)Interim results Antibiotic duration Healed Not healed (days) n=26 n=10 Total, median (IQR) 42.5 (21, 71) 32 (20, 47) Intravenous, median (IQR) 7.5 (5, 15) 6.5 (5, 24) Oral, median (IQR) 17.5 (12, 55) 14.5 (6, 23)
What can we conclude?
• Network of interested sites ready for future studies/trials
• Evaluated data collection form
• Allow us to prove equipoise between alternative treatments and
leverage for future RCTs
• ? Allow us to compare severity tools: PEDIS, WIFi, COCLASSTI
• ?Develop a ranked outcome assessment of DFIs
CID 2015robert.commons@gmail.com
Study coordinators Lyn-Li Lim Charlotte Cook Mark Hamilton
Ed Raby Mauro Vicaretti Chris Gilfillan Matthew Hope
Rob Commons Natascha Bertschi Claire Robinson Mendel Baba
Pete Lazzarini Ohide Otome Claudia White Michelle Garrett
Omar Shum Elaine Pretorius Mohamed Kola
Site PIs Parind Vora Emma Hamilton Nick Gow
Adi Torda Paul Ingram Frances St Ruth Nick Shortt
Adrian Tramontana Ronan Murray Gomathi Rajarethanam Olufemi Oshin
Annabelle Donaldson Jessie Teng Paul Gittings
Ayesha Akram Site AIs Joanne Scheepers Raquel Cowan
Cara Westphal Adam Roberts Josh Kim Richard Hanly
Chris Lemoh Adam Stewart Justin Bradley Rupert Handy
Christian McGrath Albert Lessing Kanthi Vemuri Sarah Lynar
Eugene Athan Ana Andric Kate Lennard Sharon Chen
Hasan Bhally Andrew Langlands Katy Lai Spiros Miyakis
Jennifer Wong Ana McCarthy Katherine Meyer Stephen Guy
Kate McCarthy Benjamin Lipsky Linda Watson Tamara Maycock
Keat Choong Brett Sillars Lyndon Homeming Tom Cavaye
Marjoree Sehu Caroline Bartolo Mark Lowenthal Umit Holland
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