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