National Institute for Health and Clinical Excellence

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1 National Institute for Health and Clinical Excellence Diabetic foot problems - inpatient management Guideline Consultation Table 20 September 18 October 2010 Stakeholder Associazione Infermieristica per lo Studio delle Lesioni Cutanee (AISLeC) Bailey Instruments Ltd Bedfordshire and Hertfordshire Tissue Viability Nurses Forum Bedfordshire and Hertfordshire Tissue Full General For Association: AISLeC Associazione Infermieristica per lo Studio delle Lesioni Cutanee it s a very good job. We are grateful for their help in assisting these patients Full 4.2 In the assessment of the diabetic foot, there seems to be little attention paid to the neurological risk status of the foot. There is evidence to suggest that some diabetes patients develop wounds whilst on the ward. A simple examination involving an accurate 10g Monofilament and tuning fork would suffice. This would allow ward staff to be aware of the insensate foot. If the patient is unable to feel their heel, they will not feel any pressure a wound can quickly develop. These tests are well established as a screening technique designed to identify the at-risk patient in the community. Why not use this preventative approach on wards? The tests are quick (less than 60 seconds), easy and cheap. Ref: Boyko 1997 Young & Booth 2000 Caputo 1994 Jeffcoate Full 15 8 Negative pressure wound therapy is routinely used as a first line treatment for DFU problems particularly post surgery debridement and or amputation. There is evidence to support its use for this Full 17 Box Dressings with the lowest acquisistion costs. This 81 DFU does not consider the many factors that lead to Thank you for your comment. Prevention, including risk assessment using monofilament, was outside the Scope of this guideline. However its use is covered in Clinical Guideline 10. We have revised the recommendation so that NPWT can be used as a rescue therapy, where the only alternative is amputation. We also recommend the need for further research on this intervention. We have moved the reference to cost to the end of the factors to be considered. 1 of 87

2 Viability Nurses Forum Bedfordshire and Hertfordshire Tissue Viability Nurses Forum Bedfordshire and Hertfordshire Tissue Viability Nurses Forum Bedfordshire and Hertfordshire Tissue Viability Nurses Forum Bedfordshire and Hertfordshire Tissue Viability Nurses Forum Boston Scientific Limited British Hyperbaric Association Full differences between dressings from manufacturers which experienced TVNs and podistrists are in a position to understand. Lowest acquisition cost does not always mean most cost effective and lack of evidence does not mean lack of effectiveness. Box ABPI in diabetics can provide false high readings limb and is often of little value ischae mia Full And/or podiatrist TVN. These roles are not interchangeable and a podiatrist on the team would be of greater value than a TVN. TVNs are of use to link in for strategic working and post op care Full Within 4 hours and examine for neuropathy, charcot and ischaemia. Most nurses would be doing this and most would not have the skills to detect these abnormalities. They would recognise an ulcer or skin discolouration linked to iscahemia or infection but otherwise a podiatrist would be needed to assess for the more complex problems. This will not happen overnight or at a weekend. This section needs further review for practical application Full Having fully staffed foot acre teams available at weekends will be a cost to implement Full General Boston Scientific has contributed to, and fully endorses, the detailed response from the Association of British Healthcare Industries on the Diabetic Foot Problems guideline Full General Quality of evidence: Recompression and hyperbaric oxygen therapy is a We have added that careful interpretation of results is needed. We have expanded the team to include both these roles. All the times have now been removed, other than referring to care within the first 24 hours of admission or detection of foot problems. This then allows care to be more tailored to the individual and their clinical circumstance. The guideline group considered that access to these skills in the first 24 hours of admission or detection was key. Thank you Thank you. ted 2 of 87

3 well-established treatment for decompression illness that is used world-wide. Hyperbaric oxygen therapy is already used in many other countries for treatment of diabetic foot ulcers. Since the technique cannot be patented for this use and the additional market gain would be limited, there is no financial incentive for any large commercial body to fund research of the quality that NICE would normally expect for a new drug. Nevertheless the studies that have been completed so far, and assessed by NICE in the guidelines appendix, indicate that hyperbaric oxygen is associated with a relative risk of major amputation of 0.3 with an upper 95% confidence interval of British Hyperbaric Association British Hyperbaric Association The relative risk of ulcer healing at 6 weeks is 3.36 with hyperbaric oxygen. This is a considerable potential clinical effect although it is conceded that, in this case, the 95% confidence intervals cross unity Full There is a comment regarding the apparent lack of effect of hyperbaric oxygen on minor amputation. This could, in part, be explained by an effect of hyperbaric oxygen on wounds that would otherwise have progressed to major amputation, such that a Appe ndice s less extensive procedure is required Cost effectiveness: The cost used in the analysis is not representative of actual fees charged by providers in the British Hyperbaric Association (BHA). The Association s charges are, in the main, considerably lower with some less than half the cost assumed in the analysis. Also, many BHA member facilities provide woundcare during a patient s visit for treatment in And this would have been part of the consideration of the evidence within the GDG. Thank you for your comment. The HBOT health economics model was re-evaluated using the lower cost per session (using a range of +/- 50%) provided by the stakeholders responding to the consultation. The new deterministic and probabilistic ICERs were found to be within the to /QALY range. The new ICERs were presented to the GDG during the post consultation meeting and they did not overturn their original recommendation for the 3 of 87

4 order that the patient does not need to attend two appointments in different locations. The fee for a treatment does not, therefore, always represent the cost of hyperbaric oxygen alone. use of HBOT. British Hyperbaric Association British Hyperbaric Association British Hyperbaric Association British Hyperbaric Association Full General A recent survey of cost per session across 8 multiplace hyperbaric facilities gives a median of 164, a mean of 165 ands a range of 113 to 232. With the expectation of a modest increase in throughput most, if not all, multiplace chambers will be able to reduce costs in order to achieve an incremental cost-effectiveness ratio of 20,000/QALY Appe ndice s Appe ndice s The absence of long-term outcomes in the research assessed to date forced the modellers to look at only the short term benefits of hyperbaric oxygen. Londahl and colleagues (Reference: Improved survival in patients with diabetes and chronic foot ulcers after hyperbaric oxygen therapy. Outcome of a randomised double-blind placebo controlled study. Diabetalogia (2010) 53:[Suppl1] S463) have recently published an abstract showing a significant reduction in 3 year mortality in the group treated with hyperbaric oxygen (10.5% vs 29.7%, P=0.04) so the cost-effectiveness in the current model is likely to be an underestimate Assumption that treatments have no effect on mortality. See paper on mortality immediately above Full General Infrastructure: The Guideline Development Group was deterred by the potentially high capital and potential Thank you for your comment. The HBOT health economics model was re-evaluated using the lower cost per session (using a range of +/- 50%) provided by the stakeholders responding to the consultation. The new deterministic and probabilistic ICERs were found to be within the to /QALY range. The new ICERs were presented to the GDG during the post consultation meeting and they did not overturn their original recommendation for the use of HBOT. Thank you for your comment. The article quoted is an abstract and the NICE reference case requires access to a published full text article for consideration. Likewise, the authors have acknowledged that the model may underestimate the cost-effectiveness of HBOT, the model was considered to be exploratory. Thank you for your comment. Thank you for your comment. The section which states this has been revised accordingly. 4 of 87

5 British Orthopaedic Foot and Ankle Society British Orthopaedic Foot and Ankle Society infrastructure issues associated with hyperbaric oxygen therapy. There are, however, already many hyperbaric chambers in existence nationally. The Care Quality Commission has advised that only chambers registered with the commission can treat patients for whom hyperbaric oxygen has been prescribed, recommended or advised by a medical practitioner. The majority of these registered chambers are members of the British Hyperbaric Association and are already in a position to provide a high quality, cost-effective service with the majority of UK population no more than 50 miles from a facility. There is almost complete national coverage if each unit s catchment radius extends to 100 miles Full We agree that the development of a multidisciplinary team is vital for managing these patients. We feel that this team should include both a vascular surgeon to deal with issues of ischaemia and an orthopaedic surgeon to deal with deformity and charcot neuroarthropathy. There should be ready access to a plastic surgical service Full and We agree that communication between the patient and their carers in both the primary and secondary care settings is important. In this context a multidisciplinary communication booklet held by the patient in addition to the usual GP letters which are sent may be helpful. While a named contact in a multidisciplinary team may be helpful, it will often be the case that such an individual will not be immediately available due to leave issues and limitations in hours worked. Given these concerns the use of a definitive telephone contact number is very helpful. In some circumstances the use of a fracture clinic number will often be available with staff readily available from 8 am until early evening most days of the week. Thank you. We have not specified the specific skills that the surgeon needs however, the membership of the specialist team with access to other specialists as needed would ensure that all surgical skills and expertise should be available as required. This type of information would be part of best practice discharge planning and therefore although important, is not specific to people with diabetic foot problems. recommendations on this have been added. 5 of 87

6 British Orthopaedic Foot and Ankle Society British Orthopaedic Foot and Ankle Society British Orthopaedic Foot and Ankle Society British Orthopaedic Foot and Ankle Society Alternatively the telephone number of the diabetic clinic could be used perhaps manned by a podiatrist Full In most circumstances the multidisciplinary team should be led by a consultant medical diabetologist. The fundamental requirement for healing is well controlled diabetes Full It is important to identify at an early stage the rare, very unwell patient who presents with a collection of pus under pressure which requires urgent decompression by the on call orthopaedic,general or vascular surgical teams. A definitive debridement can be undertaken later on a semi-planned basis by a specialist surgical member of the multidisciplinary team Full With regard to vascular assessment it is important to recognise that routine clinical vascular assessment and simple investigations can be compromised in diabetic patients. Doppler pressures in the foot may be artificially high due to decreased vessel wall compliance in diabetes. This can mean that ABPI measurement is unreliable in diabetics. If pulses are not palpable and a good triphasic Doppler cannot be heard then an urgent vascular opinion is required to consider the possibility of a revascularisation procedure Full MRI scanning is helpful as part of an overall diagnostic picture although clinical examination is the most useful modality. The needs of the individual and the local team will vary, so the guideline development group considered the wording to be appropriate. There are recommendations on the early identification of significant problems with appropriate referral. We have retained the recommendation on ABPI but clarified that careful interpretation of the results is needed. We have clarified the role of MRI in the diagnostic pathway. British Orthopaedic Foot and Ankle Society Full 15, , The issue of negative pressure wound therapy is of critical importance to BOFAS with regard to allowing us to provide optimum wound / ulcer healing in patients with difficult life and limb threatening problems. From the discussion presented in the guidelines it is unclear how the Health Economics Modelling came to its conclusions on the cost We have revised the recommendation so that negative pressure therapy can be used as a rescue therapy, where the only alternative is amputation. We also recommend the need for further research on this intervention. 6 of 87

7 effectiveness of negative pressure wound dressings. In particular it is not clear that the full costs of patient care following major and minor limb amputations in the short, medium and long term have been considered in their entirety. The studies quoted in the guidelines looking at negative pressure wound therapy are described as of low quality. Given this proviso the studies do fairly universally support the position that negative pressure wound therapy is associated with faster healing times for wounds and ulcers and reduced major and minor amputation rates. This mirrors the anecdotal experience of ALL the senior members of BOFAS (Education Committee, Scientific Committee and Council) who were canvassed to comment on these guidelines. We feel that it is vitally important that we are not deprived of access to negative pressure wound therapy particularly in difficult cases unresponsive to other modalities of treatment. It makes a major useful contribution to the management of large open surgical wounds and pressure sores, particularly when the wound bed lacks soft tissue support for skin grafting. (Eg. Over bare tendon or when one would have to graft directly on to bone. It is better to use negative pressure wound therapy and encourage growth of granulation tissue over the bone and graft on this as it reduces the shear stresses on the graft.) We accept that the evidence base for the use of negative pressure wound therapy needs to be improved and that it is incumbent upon us to contribute significantly to this process. British Pain Society Full 8 3 We welcome the inclusion of the need for access to specialist pain services. British Pain Society Full 7 We would welcome the inclusion of a pain assessment as part of the initial assessment process. Young et al (2006) identified a prevalence Thank you We have added a recommendation on the assessment of pain in recommendation of 87

8 of neuropathic pain in a hospital clinic population of 22.7% ( %) in Type 1 diabetic patients and 32.1 % ( %) in Type 2 patients. Pain is therefore common and not always recognized if not formally assessed and therefore we would support pain assessment as an important element of any assessment process. British Pain Society Full As well as assessing neuropathy, pain should specifically be assessed and the nature of pain identified. British Society for Paediatric Endocrinology and Diabetes (BSPED) 6.00 Gene ral This organisation responded and said they had no comments to make We have added a recommendation on the assessment of pain in recommendation , with further referral as needed. Thank you. Chartered Society of Physiotherapy (CSP) Chartered Society of Physiotherapy (CSP) Chartered Society of Physiotherapy (CSP) Full General Thank you for the opportunity to comment on this draft guidance. We appreciate the enormous amount of work undertaken by staff at the NCC and the GDG Full 7 Subsequent care: 4 to 24 hours after a patient with diabetic foot problems is admitted to hospital, or the detection of diabetic foot problems (if the patient is already in hospital) 2 nd bullet point; 4 th part: Perform a vascular assessment to determine the need for revascularisation and amputation. and then what?? We suggest it would be appropriate at this point to consider liaising with the amputee rehabilitation services locally for instigation of pre amputation counselling, rehabilitation input [ref: Amputee and Prosthetic Rehabilitation - Standards and Guidelines (2nd edition). British Society of Rehabilitation Medicine 2003] Full Other specialist services should include the amputee Thank you. Such recommendations would be part of the management of amputation, so is not covered in this guideline. However, the recommendations do state the need to have access to other specialities which could include amputee rehabilitation services. Such recommendations would be part of the management of amputation, so is not covered in this 8 of 87

9 Cordis (Johnson & Johnson Medical Ltd) & Association of British Healthcare Industries Cordis (Johnson & Johnson Medical Ltd) & Association of British Healthcare Industries rehabilitation team [ref: Amputee and Prosthetic Rehabilitation - Standards and Guidelines (2nd edition). British Society of Rehabilitation Medicine 2003] Full 4 One of the consequences of failure to heal active diabetic foot problems is amputation and with major (above the ankle) amputation rates close to 100 per week in England, the final paragraph on this page would benefit from the addition of an aspiration to reduce the number of amputations. A possible wording could be This short clinical guideline aims to provide guidance on the key components of inpatient care of people with diabetic foot problems from hospital admission onwards, with the aim of minimising the number of amputations performed across the NHS Full Given the potential for ischaemic involvement in active diabetic foot disease, the proposal for MDT members should also include both a vascular surgeon and an interventional vascular radiologist. This would help expedite the assessment of ischaemia in noted later in sections and , access to imaging and may reduce the likelihood of misdiagnosis of ischaemia as soft tissue infection as noted on 15 under Assessment and management of suspected limb ischaemia. The findings of Abou-Zamzam et al (Ann Vasc Surg 2007;21: ) support the inclusion of vascular specialists in the MDT. These investigators sought to prospectively determine whether patient-specific factors or healthcare delivery factors (influenced treatment with primary amputation versus lower extremity revascularisation in patients with critical limb ischaemia (it should be noted that a patient with active diabetic foot ulceration/tissue loss and guideline. However, the recommendations do state the need to have access to other specialities which could include amputee rehabilitation services. Although this is one of the main outcomes, it is not the only outcome considered as important to this guideline. change to the wording was considered necessary. Thank you. The recommendation states that access to other appropriate specialists, which would include a vascular surgeon or an interventional radiologist, is needed. The MDT would be responsible for consulting with any vascular surgeons where appropriate; therefore we feel the recommendation does not need changing. 9 of 87

10 ischaemia falls within the clinical definition of critical limb ischaemia ). Patients who presented with diabetes, major tissue loss, end-stage renal disease and non-ambulatory status were more likely to undergo primary amputation. This led to the conclusion that Earlier recognition of tissue loss and referral to the vascular specialist may lead to improved limb salvage. Cordis (Johnson & Johnson Medical Ltd) & Association of British Healthcare Industries Cordis (Johnson & Johnson Medical Ltd) & Association of British Healthcare Industries Cordis (Johnson & Johnson Medical The implication of this finding for the guideline is that the inclusion of both vascular surgeons and interventional radiologists on the MDT would facilitate the diagnosis and treatment of critical ischaemia and reduce the likelihood of amputation Full The recommendation perform a vascular assessment to determine the need for revascularisation or amputation and rehabilitation would benefit from re-wording to reduce the likelihood that primary amputation will take place before revascularisation has been considered. An alternative wording could be perform a vascular assessment to determine the need for revascularisation Full This seems to place the short-term cost of dressings before best practice and the longer term costs associated with more effective healing. A better wording would be Healthcare professionals from the multidisciplinary foot care team should use wound dressings that are most likely to result in rapid and effective wound healing, taking into account their clinical assessment of the wound, patient preference, the clinical circumstances and the acquisition cost of the dressing Full and This section seems rather short on recommendations for further management. The This has been reworded to perform a vascular assessment to determine the need for further interventions. The order of the factors to be considered has been revised as suggested. The recommendation has been reworded to perform a vascular assessment to determine the need for 10 of 87

11 Ltd) & Association of British Healthcare Industries after importance of vascular assessment has been recognised and the guideline would benefit from stronger statements regarding revascularisation for patients who have been diagnosed with an ischaemic component to their diabetic foot problems. A patient with active diabetic foot ulceration/tissue loss and ischaemia falls within the clinical definition of critical limb ischaemia (CLI) and such patients should always be considered for revascularisation. further interventions. However, recommendations on further interventions are outside the Scope of this guideline. Tsetis and Belli (Br J Radiol 2004;77: ) noted that patients with CLI undergoing successful revascularisation survive longer and have an increased quality of life compared with patients who have an amputation. Therefore, restoration of adequate blood supply to the foot should be attempted whenever possible in all these patients. It is unlikely that randomised trials will quantify the effect of revascularisation versus no revascularisation in these patients, because as Lepantalo et al (Eur J Vasc Endovasc Surg 1996; ) point out, It is, if not unethical, very hard to do randomised studies between surgical and nonsurgical treatments of critical limb ischaemia, and such studies could be considered only for a limited subset of patients. Put another way, randomisation of patients with critical ischaemia to deferred revascularisation will undoubtedly increase the risk of limb loss and such studies would not be sanctioned. This means that case series experience reported in the literature must be taken into account. Several studies have reported outcomes in patients with critical limb ischaemia who undergo 11 of 87

12 revascularisation versus those who do not. In these studies, patients who are not revascularised are often not amenable to surgical reconstruction or angioplasty because of the advanced nature of the disease. Faglia et al Eur J Vasc Endovasc Surg 2006;32: ) reported an odds ratio of 35.9 for above the ankle amputation in patients who were not revascularised and a significantly increased mortality risk (hazard ratio 1.68). Lepantalo et al (Eur J Vasc Endovasc Surg 1996;11: ) reported a leg salvage rate of only 40% at 1 year in diabetic patients who did not undergo arterial reconstruction. Revascularisation may be a pre-requisite for healing to take place in some patients. Hafner et al (J Am Acad Dermatol 2000;43: ) observed the value of revascularisation in healing arterial ulcers that had not healed under conservative therapy. 31% of patients healed with either conservative therapy or skin graft within 8 weeks, the remainder required revascularisation to allow healing under further conservative treatment or prepare the tissue bed for skin grafting. Uccioli et al (Diabetes Care 2010;33(5): ) have recently reported the contribution that can be made by extensive use of revascularisation (specifically angioplasty) in 510 patients with critical limb ischaemia and an active foot ulcer or gangrene. Healing was achieved in 62.3% of patients who were treated with angioplasty, compared with 48.1% of patients who were not treated with angioplasty. Similarly, 14.7% of patients who received angioplasty required a major amputation compared 12 of 87

13 with a major amputation rate of 24.1% in patients who did not receive angioplasty. Diabetic patients may be particularly prone to disease of the arteries below the knee with the consequent need for more distal revascularisation to help heal ulcers and prevent amputation. Holdsworth and Paterson (Eur J Vasc Endovasc Surg 2001;20: ) reflected this in their comment Many of the studies that demonstrate a positive effect of reconstruction on amputation particularly link the inverse relationship to distal arterial surgery. Stephenson et al (Annals of the Royal College of Surgeons of England 1993;75: ) spoke to the value of distal (ie below the knee) revascularisation in patients who all had faced imminent amputation at various levels and recommended that Diabetic patients with critical ischaemia should at the very least undergo arteriography to ensure that the possibility of successful distal revascularisation is not feasible before amputation is performed. Holstein et al (Diabetologia 2000;43: ) found that in addition to MDT care, distal revascularisation was also an important factor in reducing amputations. They concluded: A 75% reduction in the incidence of major amputations coincided with a sevenfold increase in revascularisation procedures and the establishment of a multidisciplinary diabetic foot clinic suggesting these measures are important in the prevention of diabetic leg amputations. 13 of 87

14 Bypass surgery and angioplasty are complementary revascularisation strategies, the feasibility and suitability of which can be assessed for patients on an individual basis by vascular surgeons and interventional radiologists. Faglia et al (Eur J Vasc Endovasc Surg 2005; 29: ) evaluated angioplasty as the first choice revascularisation procedure in a series of 993 diabetic patients with ischaemic foot disease and reported a major amputation rate of 1.7% at a mean of 26 months follow up. Reekers et al (Cardiovasc Intervent Radiol June; 33(3): ) investigated the role of angioplasty in 25 patients (64% diabetic) with critical limb ischaemia and tibial artery occlusions who were scheduled for amputation because they had no surgical options for revascularisation. 38% of limbs in these apparently no option but amputation patients avoided an amputation as a result of access to interventional vascular radiology. This underlines the need for assessment of patients with ischaemic disease by both vascular surgeons and interventional radiologists prior to amputation. Furthermore, there may be gains in productivity to be realised if patients undergoing diagnostic catheter angiography progressed to same-session angioplasty if there disease was considered to be amenable to percutaneous revascularisation. The value of revascularisation has been repeatedly demonstrated in the literature. Consequently, this guideline should make clear recommendations that revascularisation should be attempted where 14 of 87

15 possible. These could include: Patients with critical limb ischaemia should not undergo amputation until the feasibility and potential benefit of revascularisation has been assessed by a vascular surgeon and an interventional radiologist Below the knee revascularisation should be considered where distal arterial disease is a contributing factor. Cordis (Johnson & Johnson Medical Ltd) & Association of British Healthcare Industries Arterial disease noted during diagnostic catheter angiography and considered to be amenable to percutaneous intervention should progress to immediate angioplasty where feasible Full This section concludes that there is no evidence upon which to base recommendations for the timing of surgical management to prevent amputations. Whilst there may not be randomised trials that have directly addressed the specific question of timing, there are real-world case series reports that point to poor outcomes if revascularisation is delayed. Dick et at (J Vasc Surg 2007;45:751-61) directly addressed the question of the timing of revascularisation in patients with critical ischaemia and noted Delay of arterial revascularisation was associated with poorer outcome than immediate revascularisation. This difference was statistically significant in non-diabetic patients (P=0.003) and showed a strong trend in diabetic patients (P=0.056). The guideline recommends that vascular assessment and the need for further intervention should be undertaken within 24 hours of admission or detection. We did consider other study designs (inc observational studies) as stated in the review protocol. The study you mention was excluded due to the non diabetic population. See also comment 5. Department of Full 6 In our opinion, details about how to diagnose The diagnosis of Charcot foot is outside the Scope 15 of 87

16 Health Charcot would be helpful. of this guideline. Department of Health Department of Health Full 12 We feel that orthotic assessment should be immediately prior to discharge, and not between four and 24 hours Full 15 We consider that it is important to elicit a history of CKD (in addition to CVD) as this carries a high risk of amputation, and should have a lower threshold for surgical assessment. Department of Full General Overall, we are very positive about this guideline. Thank you. Health Diabetes UK Full General It is unclear whether the guideline will help ensure that all people with diabetes who are hospital inpatients have their feet examined to help prevent the onset of new foot disease. Guidance to ensure that foot problems for people with diabetes are prevented during the inpatient stay is an important part of overall diabetes inpatient care, as outlined in Putting Feet First. ng_feet_first_ pdf Diabetes UK Full 9 Sectio n Diabetes UK Full 9 Sectio n Please include the phrase the identity of the team must be known by non specialist healthcare professionals. This will help ensure the swift access to this team required to meet this guideline s recommendations. ng_feet_first_ pdf With regard to the necessary skills and competencies, please refer to the National Minimum Skills Framework for Commissioning of Foot Care Services for People with Diabetes. The framework is currently being revised and provides guidance on the skills required to deliver high quality diabetes foot care across a range of foot care problems and All the times have now been removed, other than referring to care within the first 24 hours of admission or detection of foot problems. However, this does not exclude a further assessment prior to discharge if needed. Recommendation now includes the need to review pre-existing kidney disease. Although important, the focus of the guideline is the management of diabetic foot problems; prevention is covered in other NICE guidance (CG10). We would consider the knowledge of specialist teams to be part of general best practice and not specific to diabetic foot care. recommendation has been added. The GDG considered that as this framework did not apply to all professionals involved in the care of people with diabetic foot problems, we should not add a reference to the recommendations. But reference to this has been made in the Evidence to Recommendation section. 16 of 87

17 Diabetes UK Full 9 Sectio n Diabetes UK Full 9 Sectio n Diabetes UK Full 10 Sectio n Diabetes UK Full 10 Sectio n Diabetes UK Full General Sectio n on care within 4 interventions required. and_skills/competencies_-_feet/ Although the recommendations in the guideline implicitly indicate that the team should be available to assess foot disease within one day it would be valuable to include this as an explicit statement, as per the Putting Feet First guidance. ng_feet_first_ pdf In order to genuinely emphasise the role of the person as a partner in making decisions about their care it would be better for the order of the wording of this recommendation to be altered. It can be amended so that a person is provided with information and explanations as described, along with the opportunity to discuss issues and ask questions, so that all of this supports informed decision making. In line with Putting Feet First, please include the following two elements as part of an initial examination and assessment: - clinical assessment of arterial circulation - an assessment of renal function ng_feet_first_ pdf In documenting any identified foot problems please include a recommendation to take a relevant history. This would support the identification of any preexisting cardiovascular disease and previous foot care problems. This section would benefit from a recommendation about what to do for individuals who do not have signs of infection, other inflammation, dislocation or fracture. Putting Feet First recommends these individuals should: All the times have now been removed, other than referring to care within the first 24 hours of admission or detection of foot problems. We consider the wording to be supportive of shared decision making, along with the Patient Centred Care which re-emphasises these principles. Recommendation now includes the need to review pre-existing kidney disease. We have also referred to vascular assessment which covers the assessment of arterial circulation We have recommended that the history of relevant pre-existing conditions and prior diabetic foot problems is taken. Thank you. This guideline covers inpatient management only. The patients you mention would not be admitted and are outside our care pathway. 17 of 87

18 hours Diabetes UK Full 11 Sectio n have their wounds dressed, with arrangements made for off-loading when indicated. ng_feet_first_ pdf While we recognise that many of the recommendations for managing signs of foot infection are included within the further management sections of the guideline, the layout of the guideline has the potential to confuse. Some of the recommendations in the further management section should be undertaken within 4 hours of admission as per the Putting Feet First guidance. These recommendations in Putting Feet First are outlined below and correlate with at least recommendations , : Deep samples for microbiological analysis (pus, soft tissue or bone, if indicated) should be obtained at the time of any surgery. Venous blood samples should be taken for culture, CRP, U and E, egfr, FBC and other tests as appropriate. Samples should be taken for microbiological examination, including pus, deep soft tissue, wound aspirate or extruded bone. te that analysis of a surface swab may provide information of only limited value. Administer antibiotics (usually intravenously) with activity against Gram positive cocci if the infection is new and limited in extent. If the infection is extensive, if the tissue is devitalised and/or the patient has already received antibiotic therapy, administer agents (usually intravenously) with activity against Gram positive and Gram negative organisms, including anaerobic bacteria. Each Trust should have antibiotic guidelines All the times have now been removed, other than referring to care within the first 24 hours of admission or detection of foot problems. This then allows care to be more tailored to the individual and their clinical circumstance. 18 of 87

19 specifically for the management of diabetic foot infections. Ensure good glycaemic control and appropriate systemic support. The diabetes specialist team should be involved as soon as possible to agree a care plan for glycaemic control and to support the patient and staff in other areas of disease management. ng_feet_first_ pdf Diabetes UK Full General Again while the recommendations to keep people with diabetes informed are contained within their own section, it would be useful for the guideline to either include or cross refer to recommendations and throughout the guideline to ensure this is emphasised as part of care at all stages, including within the first 4 hours. Furthermore it would be useful to re-iterate the principles outlined in the section on patient centred care relating to the accessibility of information on 5 of the draft guideline. It is important that all people with diabetes are provided with the support and information they need to enable them to be involved in decisions about their care, ensuring it is personally tailored. Diabetes UK Full 11 Sectio n At the GDG identify a number of factors, related to those in Putting Feet First, that would indicate the need to obtain urgent advice from a surgeon experienced in managing diabetic foot problems. These have not been outlined in as much detail in the recommendations. Please consider the inclusion of the following: (i) palpable gas in the tissues or extensive gas visible on X-ray (ii) evidence of an abscess This is key to the guideline and the principles apply throughout. However, we do not consider that repetition or cross-referencing strengthens these. This recommendation has been revised, and we have added an example of palpable gas. 19 of 87

20 Diabetes UK Full General Sectio n regardi ng care in first 4 hours Diabetes UK Full 12 Sectio n (iii) extensive spreading soft tissue infection ng_feet_first_ pdf We acknowledge that some of the recommendations for the management of critical limb ischemia are contained within the further management section of the guideline, however some of these activities are recommended as occurring within the first 4 hours of care within the Putting Feet First guideline and for clarity would benefit from being acknowledged/ cross referred to in this section. The following is the Putting Feet First recommendation for the management of critical limb ischaemia in the first 4 hours, and relate to recommendations in the guideline: An experienced vascular surgeon must assess patients with symptoms and signs of critical limb ischaemia as soon as possible. ng_feet_first_ pdf Please include the following recommendation from Putting Feet First: Provision of accurate information for the patient and the family. We welcome the recognition elsewhere in the guideline of the involvement of people with diabetes in their care during their hospital stay, and the importance of keeping people informed, and believe this should be part of the recommendations in this section. Diabetes UK is aware from feedback from people with diabetes that poor communication is an area of significant concern with regard to their care in hospital. People have reported experiences of not being kept informed, for example of changes to their treatment or the timings of procedures. This has All the times have now been removed, other than referring to care within the first 24 hours of admission or detection of foot problems. This then allows care to be more tailored to the individual and their clinical circumstance. This is key to the guideline and the principles apply throughout. Please see also the Patient Centred Care which outlines the principle of involving family and/or carers as appropriate and with permission. 20 of 87

21 Diabetes UK Full 12 Sectio n caused feelings of disempowerment and distress as a result. I couldn't understand this and tried to question it but was told to trust them, we know what we are doing. I wasn't convinced but had no choice. During the late afternoon of the third day I could feel myself burning up. I became very nervous of treatment I was receiving as within the ward it was obvious that the left hand did not know what the right hand was doing I felt like a hospital tick box, confused and feeling very ill and scared s-reports-and-resources/reports-statistics-and- case-studies/reports/collation-of-inpatient- Experiences-2007/ Putting Feet First also highlights the importance of keeping people informed, particularly as they may be concerned about the possibility of amputation. ng_feet_first_ pdf Please include the following recommendation from Putting Feet First: Provision of contact details of representatives of the specialist team. Access to the diabetes specialist team during a hospital stay is another issue identified as important by people with diabetes. They always explained what was happening and answered any questions that they could. Sometimes they were only able to say that I would need to ask the diabetes nurse, but were then able to tell me when I would be seeing her. s-reports-and-resources/reports-statistics-and- case-studies/reports/collation-of-inpatient- It has been recommended that each person should have a named individual. General best practice would then ensure that the patient and family can contact their named professional as appropriate. This is not specific to diabetic foot care, so no recommendations have been made. 21 of 87

22 Experiences-2007/ Diabetes UK Full 12 Sectio n Diabetes UK Full 12 Sectio n The Think Glucose patient assessment tool (NHS Institute for Innovation and Improvement) recommends that people with diabetes who request access to the diabetes specialist team should always be referred to them. ng_feet_first_ pdf glucose/campaign_and_support_programme.html Please include the following recommendation from Putting Feet First: Assessment of the other medical and social needs of the patient and their dependants. ng_feet_first_ pdf Please include the following recommendation from Putting Feet First: Liaison with the in-patient diabetes specialist team in the management of general diabetes care. ng_feet_first_ pdf The inpatient diabetes specialist team are an important resource to support the management of diabetes care during hospital stays, recommended by a number of organisations and resources. glucose/campaign_and_support_programme.html sition_statements/improving-inpatient-diabetes-care- -what-care-adults-with-diabetes-should-expectwhen-in-hospital/ We have recommended that relevant pre-existing medical conditions be assessed. In regards to the wider social needs, this would be part of discharge planning and not specific to diabetic foot care so no recommendations have been made. We would anticipate that the specialist and general teams would be in communication as for other conditions. Recommendations on this were not added. 22 of 87

23 Diabetes UK Full 12 Sectio n Diabetes UK Full 12 Sectio n Diabetes UK Full 14 Sectio n Please consider including a statement about communicating with the original referee. We are aware of examples in practice where a referring podiatrist in the community is not made aware of individuals they referred to hospital being discharged post treatment. As identified by the GDG in the discussion of the evidence into recommendations, and in Putting Feet First, a surface swab may provide information of only limited value, and it would be useful to acknowledge this within the recommendation, and include a recommendation that the source of the swab should be noted in the records. ng_feet_first_ pdf Please include the term and trust protocols at the end of the statement. Diabetes UK Full General Please include the term critical in the section covering the management of suspected limb ischaemia. Diabetes UK Full 16 Sectio n Diabetes UK Full 16 Sectio n Please clarify that the specialist assessment should be undertaken by a vascular surgeon as per the Putting Feet First guideline. ng_feet_first_ pdf Please add the term critical to limb ischaemia as per the Putting Feet First guideline. ng_feet_first_ pdf Diabetes UK Full General While we recognise the guideline is for inpatient management, Diabetes UK is questioning whether the outpatient management of active foot disease, will be acknowledged, in line with Putting Feet First recommendations. This type of information would be part of best practice discharge planning and therefore although important, is not specific to people with diabetic foot problems. recommendations on this have been added. The recommendation does suggest that this not the first-choice of investigation. Record keeping would be part of any protocol of swab taking and any person taking a swab should be competent to do so. recommendations on this have been added. This has not been added as all recommendations should be interpreted in the knowledge of local protocols and policies. The guideline group considered that this should not be added as the definition of critical limb ischaemia excludes people with diabetes. We have recommended that a specialist assessment be undertaken, but did not consider it appropriate to recommend who should do this. But anyone undertaking such an assessment should have the appropriate skills and competencies. The GDG considered that this should not be added as the definition of critical limb ischaemia excludes people with diabetes. Although important, outpatient management is outside the scope of this guideline. 23 of 87

24 ng_feet_first_ pdf Diabetes UK Full General It is unclear whether the guideline will help ensure that all people with diabetes who are hospital inpatients have their feet examined to help prevent the onset of new foot disease. Guidance to ensure that foot problems for people with diabetes are prevented during the inpatient stay is an important part of overall diabetes inpatient care, as outlined in Putting Feet First. ng_feet_first_ pdf Foot in Diabetes UK Full 8 11 While MR Scan is gold standard access to and resources for this vary across the country Foot in Diabetes UK Full 9 9 A podiatrist is an essential member of the MDT. The team should also include an orthotics specialist and a microbiologist (infection specialist). Foot in Diabetes UK Full 13 3 While MR Scan is gold standard access to and resources for vary across the country. Foot in Diabetes UK Full 13 3 This whole section needs re-writing; in its present format it is very confusing with too many negatives. It may stop people probing wounds, which would result in poor clinical practice. Foot in Diabetes UK Full 15 7 The statement that Negative Pressure Therapy to be used only as part of clinical trial is very contentious. Whilst the published evidence is of low quality there are undoubted patient benefits in terms of limb salvage and reduced bed stays. It has become a standard treatment for postoperative wounds in many centres across the UK. t to use Negative Pressure will put back diabetic foot care a decade. This guidance is also contrary to SIGN 116; who in point says negative pressure wound therapy should be considered in patients with active foot The focus of the guideline is the management of diabetic foot problems; prevention is covered in other NICE guidance (CG10). MRI was considered to be a valuable tool in the diagnosis of osteomyelitis and is therefore recommended. The podiatrist is now part of the team. And we have recommended that the MDT needs access to the other specialities, such as you suggest. MRI was considered to be a valuable tool in the diagnosis of osteomyelitis and is therefore recommended. The wordings of these recommendations have all been clarified. We have revised the recommendation so that NPWT can be used as a rescue therapy, where the only alternative is amputation. We also recommend the need for further research on this intervention. 24 of 87