1. What’s new in diabetes foot care? NICE and beyond Dr Simon Ashwell Consultant Diabetologist The James Cook University Hospital Middlesbrough

2. Outline NICE 2015 Medical management of osteomyelitis Microbiological samples Grafix TCC-EZ Multidisciplinary teams

4. NICE NG19: Foot risk assessment Neuropathy Ischaemia (incl. ABPI) Callus Deformity Low risk0 moderate risk1 high risk>1, previous ulcer, dialysis Active diabetic foot problem: ulcer, acute Charcot, infection, gangrene

5. 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 riskannual Moderate risk3-6 months High risk1-2 months

6. 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

7. 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

8. 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

9. 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.

10. NICE NG19: SINBAD Use a standardised grading system such as SINBAD S ite: midfoot or hindfoot I schaemia N europathy B acterial infection A rea >1cm D epth: muscle, tendon or deeper

11. NICE NG19: SINBAD SINBAD scoreMedian time to healing (days) 077 1 270 3126 4140 5113 6577 Ince et al. Diabetes Care 2008

12. 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

13. NICE NG19: Treatment Do not use: Autologous platelet-rich plasma gel Growth factors Hyperbaric oxygen

14. 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

15. 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

16. Lázaro-Martínez et al. Diabetes Care 2014

17. 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

18. 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

19. 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

21. 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

22. 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 similar outcomes in terms of healing rates, time to healing, and short-term complications Lázaro-Martínez et al. Diabetes Care 2014 RCT of Medical vs. Surgical Treatment of Osteomyelitis – Conclusions

23. Backhouse et al, Journal of Foot and Ankle Research 2015 Swabs vs. tissue samples in diabetic foot ulcers – CODIFI methods 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

24. Swabs vs. tissue samples in diabetic foot ulcers – CODIFI results 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

25. Swabs vs. tissue samples in diabetic foot ulcers – CODIFI results 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

26. Swabs vs. tissue samples in diabetic foot ulcers – CODIFI conclusions 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

27. Outline NICE 2015 Medical management of osteomyelitis Microbiological samples Grafix TCC-EZ Multidisciplinary teams

28. Lavery et al, International Wound Journal 2014

29. 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

30. 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

31. RCT of Grafix® in diabetic foot ulcers – results Lavery et al, International Wound Journal 2014 62 % 21 %

32. RCT of Grafix® in diabetic foot ulcers – results GrafixControlp Median time to healing (days)42700.019 Study visits to healing (n)612<0.001 Adverse events (%)44660.031 Infections (%)18360.044 Adjusted hazard ratio for healing4.77 (2.3-10.0, p<0.0001) Lavery et al, International Wound Journal 2014

33. 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

34. Armstrong et al. Diabetes Care 2001 ©2001 by American Diabetes Association Total contact casting – it works…

35. 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…

36. 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

37. Fibreglass TCC£74 Irremovable Aircast (iTCC) £173 Orthotic TCC£413 TCC-EZ£699 TCC-EZ cost (12 week)

38. Outline NICE 2015 Medical management of osteomyelitis Microbiological samples Grafix TCC-EZ Multidisciplinary teams

39. Diabetes-related lower extremity amputation incidence in South Tees 1995 -2010