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What’s new in diabetes foot care? NICE and beyond
Dr Simon AshwellConsultant DiabetologistThe James Cook University Hospital
Middlesbrough
Outline • NICE 2015
• Medical management of osteomyelitis
• Microbiological samples
• Grafix
• TCC-EZ
• Multidisciplinary teams
NICE NG19: Foot risk assessment
• Low risk 0• moderate risk 1• high risk >1, previous ulcer,
dialysis
Active diabetic foot problem: ulcer, acute Charcot,infection, gangrene
NICE NG19: Foot risk assessment
• Start annual foot assessment age 12 yr
• Assess new referrals within:
• 2-4 weeks if high risk
• 6-8 weeks if moderate risk
• Make special arrangements for housebound/ disabled/ care homes
• Reassess:
• Low risk annual
• Moderate risk 3-6 months
• High risk 1-2 months
NICE NG19: In-patient foot risk assessment
• Feet should be examined for risk of ulceration on admission to hospital
• If moderate or high risk:
• Give pressure redistribution device to offload heel pressure
• Refer to foot protection service on discharge
NICE NG19: Arrange immediate admission if life- or limb-threatening diabetic foot problem & inform MDT
• Ulceration with fever/ signs of sepsis• Ulceration with ischaemia• Clinical concern of deep soft tissue or bone
infection• Gangrene
Transfer responsibility of care to a consultant member of the diabetes foot MDT if diabetic foot problem is the primary in-patient issue
NICE NG19: The Multidisciplinary team
The MDT should be lead by a named HCP and consist of:
• Diabetes• Podiatry• DSN• Vascular surgery• Microbiology• Orthopaedics• Biomechanics/ orthotics• Interventional radiology• Casting• Wound care
NICE NG19: CV disease
….Take into account that they may have an undiagnosed
increased risk of cardiovascular disease that may need
further investigation and treatment.
NICE NG19: SINBAD
Use a standardised grading system such as SINBAD• Site: midfoot or hindfoot
• Ischaemia
• Neuropathy
• Bacterial infection
• Area >1cm
• Depth: muscle, tendon or deeper
NICE NG19: SINBAD
SINBAD score Median time to healing (days)
0 77
1 77
2 70
3 126
4 140
5 113
6 577
Ince et al. Diabetes Care 2008
NICE NG19: Treatment• Offer non-removable casting to offload plantar non-ischaemic
non-infected forefoot and midfoot ulcers.
• Offer an alternative offloading device until casting can be applied
• Consider negative pressure would therapy after surgical debridement on the advice of the MDT
• Consider dermal substitutes as an adjunct to standard care only when healing has not progressed and on the advice of the MDT
• Use dressings based on clinical assessment of the wound, patient preference and acquisition cost
NICE NG19: Treatment
Do not use:• Autologous platelet-rich plasma gel• Growth factors• Hyperbaric oxygen
NICE NG19: Management of infection• If infection suspected with ulceration take a soft tissue or
bone sample from the base of a debrided wound, or if not possible, a deep swab
• Do not use antibiotics for more than 14 days for mild soft tissue infections
• For moderate/ severe infections ensure antibiotics cover gram +ve, gram –ve and anaerobic organisms
• 6 weeks antibiotics for osteomyelitis
NICE NG19: Charcot Foot Syndrome
• Diagnose based on clinical findings and X-ray
• MRI if X-ray is normal but Charcot suspected.
• Offload in a non-removable device
• Do not use bisphosphonates
• Monitor with foot skin temperature and serial x-rays
Lázaro-Martínez et al. Diabetes Care 2014
• Neuropathic forefoot ulcers• Excluded exposed bone at base of ulcer• Diagnosis of osteomyelitis:
– Probe to bone– X-ray
• Randomised to: – antibiotics alone– conservative surgery
• Follow up 12 weeks then further 12 weeks after healing
RCT of Medical vs. Surgical Treatment of Osteomyelitis – Methods
Lázaro-Martínez et al. Diabetes Care 2014
• Oral
• Empiric first:
– Ciprofloxacin
– Co-amoxiclav
– Co-trimoxazole
• Adjusted according to result of tissue culture
• 12 weeks (stopped if healing < 12 weeks)
RCT of Medical vs. Surgical Treatment of Osteomyelitis – Antibiotic group (AG)
Lázaro-Martínez et al. Diabetes Care 2014
• Conservative• 10 days empiric then specific antibiotics post-op
RCT of Medical vs. Surgical Treatment of Osteomyelitis – Surgery group (SG)
Lázaro-Martínez et al. Diabetes Care 2014
Lázaro-Martínez et al. Diabetes Care 2014
• 18 patients (75%) achieved primary healing in AG and 19 (86%) in SG (p=0.33)
• Median time to healing was 7 weeks in AG and 6 weeks in SG (p=0.72)
• Conditions of four patients from AG worsened (16.6%), and they underwent surgery
• Three patients from SG required reoperation
• No difference was found between the two groups regarding minor amputations
RCT of Medical vs. Surgical Treatment of Osteomyelitis – Results
Lázaro-Martínez et al. Diabetes Care 2014
• Strengths:• Prospective RCT• Appropriate design
• Limitations• Unblinded• Small numbers – type 2 statistical error• Groups not well matched• Relatively short follow up• Lack of confirmatory diagnosis of osteomyelitis
Antibiotic therapy and surgical treatment had similaroutcomes in terms of healing rates, time to healing, andshort-term complications
Lázaro-Martínez et al. Diabetes Care 2014
RCT of Medical vs. Surgical Treatment of Osteomyelitis – Conclusions
Backhouse et al, Journal of Foot and Ankle Research 2015
Swabs vs. tissue samples in diabetic foot ulcers – CODIFImethods
• Aim: to evaluate the extent to which results from swabs and tissue cultures agree with each other
• Multicentre study - 25 Sites in England
• 401 patients with infected diabetic foot ulcer
• All patients had a swab and tissue sample before antibiotics started
Swabs vs. tissue samples in diabetic foot ulcers – CODIFIresults
• 395 patients had both swab and tissue sample reported
• At least one pathogen reported:
• 70% of swabs
• 86% tissue
• Difference in pathogens in 58% patients
• 37% additional pathogens in tissue sample
• 13% different pathogens
• 8% additional pathogens in swab
Backhouse et al, Journal of Foot and Ankle Research 2015
Swabs vs. tissue samples in diabetic foot ulcers – CODIFIresults
• Higher reporting of most prevalent pathogens in tissue samples:
• Gram positive cocci
• Gram negative bacilli
• Anaerobes
• Streptococci
• Enterococci
• Older ulcers had a reduced odds of reporting more pathogens in tissue samples vs. swabs
Backhouse et al, Journal of Foot and Ankle Research 2015
Swabs vs. tissue samples in diabetic foot ulcers – CODIFIconclusions
• Swabs and tissue samples are not equal
• More pathogens cultured from tissue samples vs. swabs
Backhouse et al, Journal of Foot and Ankle Research 2015
Outline • NICE 2015
• Medical management of osteomyelitis
• Microbiological samples
• Grafix
• TCC-EZ
• Multidisciplinary teams
Lavery et al, International Wound Journal 2014
RCT of Grafix® in diabetic foot ulcers – what is Grafix®?
A cryopreserved placental membrane
• Collagen-rich extracellular matrix• Growth factors• Neonatal fibroblasts• Mesenchymal stem cells• Epithelial cells
RCT of Grafix® in diabetic foot ulcers – methods
• Prospective US multi-centre single-blinded RCT
• Superficial non-infected neuropathic ulcers
• Randomised to 12 weeks of:
– Standard treatment: debridement and offloading
– Gravix: weekly application in addition to standard treatment
• Independent, blinded confirmation of healing
Lavery et al, International Wound Journal 2014
RCT of Grafix® in diabetic foot ulcers – results
Lavery et al, International Wound Journal 2014
62%
21%
RCT of Grafix® in diabetic foot ulcers – results
Grafix Control p
Median time to healing (days) 42 70 0.019
Study visits to healing (n) 6 12 <0.001
Adverse events (%) 44 66 0.031
Infections (%) 18 36 0.044
Adjusted hazard ratio for healing 4.77 (2.3-10.0, p<0.0001)
Lavery et al, International Wound Journal 2014
RCT of Grafix® in diabetic foot ulcers – conclusions
• Strengths
– Well designed and appropriately powered
– Single-blinded with independent assessment
• Weaknesses
– Poor healing in control group but no different to other control studies
Grafix aids healing of superficial neuropathic diabetic foot
ulcers in addition to standard treatment – 4 weeks reduction
Lavery et al, International Wound Journal 2014
Armstrong et al. Diabetes Care 2001©2001 by American Diabetes Association
Total contact casting – it works…
Type and frequency of plantar offloading used across 895 clinics.
Wu et al. Diabetes Care 2008©2008 by American Diabetes Association
Total contact casting – but it’s underused…
• One piece roll-on woven TCC
• Cast shoe
• Can be applied by a podiatrist
• 10 min
• Clean
• Associated with a 450% increase in TCC usage
TCC-EZ
E. Fife et al Advances in Skin and Wound Care 2014
Fibreglass TCC £74
Irremovable Aircast (iTCC) £173
Orthotic TCC £413
TCC-EZ £699
TCC-EZ cost (12 week)
Outline • NICE 2015
• Medical management of osteomyelitis
• Microbiological samples
• Grafix
• TCC-EZ
• Multidisciplinary teams
Diabetes-related lower extremity amputation incidence in South Tees 1995 -2010