3
Lower extremity amputation (LEA) is a life changing and devastating complication of diabetes. For patients with diabetes it occurs 15 times more commonly than in people without diabetes. Diabetes is now present in nearly 50% of all patients undergoing LEA 1 in western society. In the UK, between 0.5% and 1.3% of all patients with diabetes have undergone LEA, 2,3 but worldwide the inci- dence is very variable and may be as high as 7%. 4 In the majority of cases foot ulcers are a precursor of LEA. It is estimated that 5% of people with diabetes have ever had a foot ulcer 2,4 and around 1.4% of them have a foot ulcer at any one time, 4 and that one in six people with diabetes will have a foot ulcer at some time in their life. LEA has a devastating impact on a patient’s quality of life. LEA diminishes mobility and can prevent a patient driving, being able to work and socialising, with conse- quential effects on low mood and functional capacity. Often LEA could have been prevented, thus avoiding these consequences. Diabetes UK has recently high- lighted the high rates of amputations due to diabetes in the UK, and that 100 patients from a diabetes population of 2.3 million are undergoing amputation each week. 5 A large number of these amputations are potentially avoid- able. The hope is that improved foot health care may reduce the rate of amputation, but what is the evidence? Changes in amputation rates Various studies have been reported showing changes in amputation rates. Encouragingly, these generally identify a decrease in amputation rates from population- based studies. Although this may reflect a lack of report- ing of negative studies, improvements have been shown across a number of different health care services, although mainly in Europe. Baseline rates of amputa- tions for the 1990s are remarkably consistent at around 500–550 per 100 000 patients with diabetes. 1,6–8 Rates have been reported to decline to 363 per 100 000 of patients with diabetes in the Netherlands, 6 around 300 in Germany and Scotland (Krishnan et al. 8 and local data), and 160/170 in England, 1,8 whilst significant declines in amputations have also been reported in Sweden, 9 Denmark, 10 Spain, 11 and Finland. 12 The incidence of diabetes-related amputations can also be reported as the rate per 100 000 of the general population. Some people prefer this, as it avoids difficul- ties about ascertaining data on the number of patients with diabetes. However, this will underestimate the success of many programmes as the number of patients with diabetes is doubling at least every 10 years. Despite this, some studies have still shown a decrease in amputa- tions using this approach, with decreases from 19.1 to 9.4, 9 from 27.2 to 6.9, 10 and from 7.4 to 2.8 8 per 100 000 of the general population. As the number of patients with diabetes increases, many patients will have a short duration of diabetes, which may skew the results of changing amputation rates in a falsely positive direction. However, we have data show- ing a reduction in major amputation rates even after correcting for diabetes duration, decreasing from 512 to 288 per 100 000 people with diabetes. Many studies show that the main improvements are due to reductions in the rate of major amputation, which include all amputations above the ankle. 1,8,9 The same studies demonstrate very little change in the rates of minor amputation, which include anything distal to the ankle, and in the majority of cases are toe or ray exci- sions. Such minor amputations are often judged to be appropriate interventions, as they can prevent subse- quent major amputations. Thus, in summary, there appears to be a decline in the rate of amputations for patients with diabetes, which is due to a reduction in numbers of major amputations. Caveats on interpretation of amputation data Many of these reports come from centres of excellence, and may reflect sporadic and isolated reductions in amputations. Indeed, one study demonstrates that, even in centres of excellence, amputation rates can start to increase again if necessary clinical resources are removed from the diabetes foot-care team (Krishnan et al. 8 and personal communication). However, the Dutch study is possibly one of the only national data sets to demonstrate widespread improvements in amputations 6 which may indicate that the improvements are more than sporadic. In addition, although not established as an epidemiology research project, the Scottish Diabetes Survey has shown a reduction in prevalent amputations across Scotland from 0.8% in 2003 to 0.4% in 2006. 2 Although all clinicians are keen to avoid amputation, an amputation is not necessarily the worst outcome for a patient. Making an early decision to amputate can be best for the patient, if it is thought to be an inevitable out- come. It may well be preferable to allowing a patient to continue with a non-healing ulcer. In such a circum- stance, amputation can improve the patient’s quality of life, improve mobility and decrease dependency on health care professionals in the longer term. As a conse- quence, interpreting data on amputations needs to done with insight given this proviso. Survival rates for patients with diabetes are increas- ing. 13,14 As patients with diabetes live longer, and have diabetes for longer, they will be at increased risk of dia- betic foot problems. It is thus conceivable that there will be an increase in amputations as patients live longer. However, the hope is that patients’ general health will improve as their survival increases, but only time will tell! Amputation prevention What are the key elements resulting in a decrease in amputations? Unfortunately, the evidence addressing this issue is weak. Development of multidisciplinary foot clinics (MDFCs) has been associated with improved outcomes for patients with diabetic foot ulcers. 9,15,16 Many of the studies, described above, demonstrating reductions in amputation rates have attributed this to the existence or L EADER Pract Diab Int October 2008 Vol. 25 No. 8 Copyright © 2008 John Wiley & Sons 297 Amputations in diabetes: a changing scene

Amputations in diabetes: a changing scene

Embed Size (px)

Citation preview

Page 1: Amputations in diabetes: a changing scene

Lower extremity amputation (LEA) is a life changing anddevastating complication of diabetes. For patients withdiabetes it occurs 15 times more commonly than in people without diabetes. Diabetes is now present in nearly50% of all patients undergoing LEA1 in western society. Inthe UK, between 0.5% and 1.3% of all patients with diabetes have undergone LEA,2,3 but worldwide the inci-dence is very variable and may be as high as 7%.4 In themajority of cases foot ulcers are a precursor of LEA. It isestimated that 5% of people with diabetes have ever hada foot ulcer2,4 and around 1.4% of them have a foot ulcerat any one time,4 and that one in six people with diabeteswill have a foot ulcer at some time in their life.

LEA has a devastating impact on a patient’s quality oflife. LEA diminishes mobility and can prevent a patientdriving, being able to work and socialising, with conse-quential effects on low mood and functional capacity.Often LEA could have been prevented, thus avoidingthese consequences. Diabetes UK has recently high-lighted the high rates of amputations due to diabetes inthe UK, and that 100 patients from a diabetes populationof 2.3 million are undergoing amputation each week.5 Alarge number of these amputations are potentially avoid-able. The hope is that improved foot health care mayreduce the rate of amputation, but what is the evidence?

Changes in amputation ratesVarious studies have been reported showing changes in amputation rates. Encouragingly, these generally identify a decrease in amputation rates from population-based studies. Although this may reflect a lack of report-ing of negative studies, improvements have been shownacross a number of different health care services,although mainly in Europe. Baseline rates of amputa-tions for the 1990s are remarkably consistent at around500–550 per 100 000 patients with diabetes.1,6–8 Rateshave been reported to decline to 363 per 100 000 ofpatients with diabetes in the Netherlands,6 around 300 inGermany and Scotland (Krishnan et al.8 and local data),and 160/170 in England,1,8 whilst significant declines inamputations have also been reported in Sweden,9Denmark,10 Spain,11 and Finland.12

The incidence of diabetes-related amputations canalso be reported as the rate per 100 000 of the generalpopulation. Some people prefer this, as it avoids difficul-ties about ascertaining data on the number of patientswith diabetes. However, this will underestimate the success of many programmes as the number of patientswith diabetes is doubling at least every 10 years. Despitethis, some studies have still shown a decrease in amputa-tions using this approach, with decreases from 19.1 to9.4,9 from 27.2 to 6.9,10 and from 7.4 to 2.88 per 100 000of the general population.

As the number of patients with diabetes increases,many patients will have a short duration of diabetes,which may skew the results of changing amputation ratesin a falsely positive direction. However, we have data show-ing a reduction in major amputation rates even after

correcting for diabetes duration, decreasing from 512 to288 per 100 000 people with diabetes.

Many studies show that the main improvements aredue to reductions in the rate of major amputation, whichinclude all amputations above the ankle.1,8,9 The samestudies demonstrate very little change in the rates ofminor amputation, which include anything distal to theankle, and in the majority of cases are toe or ray exci-sions. Such minor amputations are often judged to beappropriate interventions, as they can prevent subse-quent major amputations. Thus, in summary, thereappears to be a decline in the rate of amputations forpatients with diabetes, which is due to a reduction innumbers of major amputations.

Caveats on interpretation of amputation dataMany of these reports come from centres of excellence,and may reflect sporadic and isolated reductions inamputations. Indeed, one study demonstrates that, evenin centres of excellence, amputation rates can start toincrease again if necessary clinical resources are removedfrom the diabetes foot-care team (Krishnan et al.8 andpersonal communication). However, the Dutch study ispossibly one of the only national data sets to demonstratewidespread improvements in amputations6 which mayindicate that the improvements are more than sporadic.In addition, although not established as an epidemiologyresearch project, the Scottish Diabetes Survey has showna reduction in prevalent amputations across Scotlandfrom 0.8% in 2003 to 0.4% in 2006.2

Although all clinicians are keen to avoid amputation,an amputation is not necessarily the worst outcome for apatient. Making an early decision to amputate can be bestfor the patient, if it is thought to be an inevitable out-come. It may well be preferable to allowing a patient tocontinue with a non-healing ulcer. In such a circum-stance, amputation can improve the patient’s quality oflife, improve mobility and decrease dependency onhealth care professionals in the longer term. As a conse-quence, interpreting data on amputations needs to donewith insight given this proviso.

Survival rates for patients with diabetes are increas-ing.13,14 As patients with diabetes live longer, and have diabetes for longer, they will be at increased risk of dia-betic foot problems. It is thus conceivable that there willbe an increase in amputations as patients live longer.However, the hope is that patients’ general health willimprove as their survival increases, but only time will tell!

Amputation preventionWhat are the key elements resulting in a decrease inamputations? Unfortunately, the evidence addressing thisissue is weak.

Development of multidisciplinary foot clinics(MDFCs) has been associated with improved outcomesfor patients with diabetic foot ulcers.9,15,16 Many of thestudies, described above, demonstrating reductions inamputation rates have attributed this to the existence or

LEADER

Pract Diab Int October 2008 Vol. 25 No. 8 Copyright © 2008 John Wiley & Sons 297

Amputations in diabetes: a changing scene

Ldr Leese 93.08.qxp 26/9/08 14:43 Page 1

Page 2: Amputations in diabetes: a changing scene

development of MDFCs. The key elements of an MDFCappear to be a specialist podiatrist and orthotist, with a dedicated diabetologist, who has rapid access to a vascular radiologist, a vascular surgeon and an ortho-paedic surgeon when required.

For patients with neuropathic foot ulcers, there isgood evidence that total contact casting is beneficial forhealing,17 which should reduce amputations. However, aremovable cast walker, made irremovable, appears to beas effective at healing ulcers.18

Although purely neuropathic ulcers can lead ontoLEA, the neuro-ischaemic foot ulcer is a greater chal-lenge to achieve healing and prevent amputations.Arteriopathy in the patient with diabetes is different fromstandard peripheral vascular disease. In patients with dia-betes, arterial disease tends to occur more in small distalvessels, rather than larger proximal vessels. Diseased distal vessels mean that bypass surgery is frequently notpossible because there are no adequate distal arteries toanastamose. Also, angioplasty is more difficult in smallerperipheral vessels as distal vessels are more likely to rupture and distal embolisation is a greater risk.

However, small improvements in arterial flow maymake a big clinical difference. In a recent study, patientswho had undergone revascularisation did end up withfewer major amputations than those who were not revascularised.19 However, this was an observational study,and there may have been bias in patient allocation.Additionally, in the small Danish study, reduced amputa-tions were associated with increased vascular interven-tions.10 However, the reduction in amputation rates acrossthe Netherlands was associated with no change in rates ofvascular interventions.6 Although there are clearly someindividual patients who benefit from vascular interven-tion, the role of surgical vascular intervention in prevent-ing amputations overall in diabetes remains controversial.

Of increasing interest is the role of treating modifiablecardiovascular risk factors to prevent amputations. The UKProspective Diabetes Study demonstrated that tight bloodpressure and glycaemic control showed a non-significanttrend towards decreased amputation with a relative risk of 0.5120 and 0.6121 respectively. Canavan et al. showed anincreasing use of statins (5% to 20%), ACE inhibitors(15% to 38%) and aspirin (22% to 33%) during the timeperiod that they demonstrated lowered amputations.1Locally, we have shown a decrease in mean blood pressure(140/79mmHg to 137/75mmHg), HbA1c (8.1% to 7.5%)and serum cholesterol concentrations (5.0mmol/L to4.4mmol/L) across the diabetes population at a time whenamputations reduced.

The MDFC may be the central component of organ-ised diabetes foot care, such that patients with diabetes inthe community can gain rapid access to specialised serv-ices. Thus, organisation of community foot care and goodcommunication links with the centre may be important forquality foot care and amputation prevention.

Amputations are usually preceded by foot ulceration.Diabetic foot screening programmes have been devel-oped22–24 which integrate a number of known risk fac-tors,3,22 and have been demonstrated to successfully iden-tify patients at risk of foot ulceration in day-to-day clinical

settings.23,24 Lack of adequate health care resources is aproblem in most countries and is likely to get worse withthe current epidemic of diabetes. Identification of patientsat greatest risk of foot problems allows appropriate treat-ments to be directed towards those at greatest need.

Simple education programmes have been shown toprevent amputations in patients with diabetes,25 but thegeneralisability and sustainability of such programmesremain untested. Orthotic interventions26,27 have beenshown to reduce the rates of foot ulceration and,although it is likely that this will reduce amputation rates,this has not formally been demonstrated. One study of 70patients with diabetes demonstrated a reduction in majoramputations from 33% to 9% with the use of hyperbaricoxygen in patients with neuro-ischaemic foot ulcers.28

Further research is required to identify which treat-ments are most effective at reducing amputations.

Survival after amputationPatients with diabetes, who undergo major LEA, have atwo-year median mortality of up to 50%.29–32 After onemajor LEA, patients with diabetes are more likely toundergo a further amputation, and are more likely to suffer cardiac failure, than people without diabetes whohave had an LEA.29 Amputation is frequently a surrogatemarker of vascular disease.

In a recent study, staff who were providing routinefoot-ulcer care within an MDFC also focused on optimalmanagement of glycaemic control, blood pressure anddyslipidaemia, and promoting the use of ACE inhibitors.They demonstrated a five-year mortality rate decreasingfrom 48% to 27%.33 Attention to treating cardiovascularrisk factors appears to prolong survival in this group of patients.

SummaryThere are some encouraging data that, in areas wherediabetes foot services are well organised and integrated,the rate of amputations may be declining for patientswith diabetes. Although there is some evidence ofimprovement, a lot more can, and needs to be done asmany amputations are avoidable. Best practice needs tobe shared worldwide. The Scottish Government hasinvested in a ‘Foot Action Group’ and a two-year DiabetesNational Foot Co-ordinator with the aim to improve footcare in Scotland. The Scottish Foot Action Group is work-ing with Foot in Diabetes UK (FDUK) and works withDiabetes UK on various projects. These latter groups arealso working with the Joint British Diabetes SocietiesInpatient Care Working Group to provide guidance foracute foot problems. In addition, there are various initia-tives being undertaken across the rest of Europe andbeyond. Hopefully, all this should help to improve out-comes for patients with diabetes who have foot problemsin the future.

Graham P Leese, MD, FRCP, FRCPE, Consultant inDiabetes, Ninewells Hospital, Dundee, UK, andChairman of the Scottish Diabetes Foot Action GroupChristopher J Schofield, MB ChB, MRCP, Registrar inDiabetes, Ninewells Hospital, Dundee, UK

LEADER

298 Pract Diab Int October 2008 Vol. 25 No. 8 Copyright © 2008 John Wiley & Sons

Ldr Leese 93.08.qxp 26/9/08 14:43 Page 2

Page 3: Amputations in diabetes: a changing scene

References1. Canavan RJ, Unwin NC, Kelly WF, et al. Diabetes- and nondia-

betes-related lower extremity amputation incidence before andafter the introduction of better organized diabetes foot care:continuous longitudinal monitoring using a standard method.Diabetes Care 2008; 31: 459–463.

2. Scottish Diabetes Survey monitoring group. Scottish DiabetesSurvey 2006. http://www.scotpho.org.uk/nmsruntime/saveasdialog.asp?lID=4128&sID=2883 [last reviewed 1/09/08].

3. Abbott CA, Carrington AL, Ashe H, et al. The North WestDiabetes Foot Care Study: incidence of, and risk factors for, newdiabetic foot ulceration in a community-based cohort. Diabet Med2002; 19: 377–384.

4. Boulton AJM, Vileikyte L, Ragnarson-Tennvall G, et al. Theglobal burden of diabetic foot disease. Lancet 2005; 366:1719–1723.

5. Diabetes UK. 100 people a week lose a limb through diabetes.http://www.diabetes.org.uk/en/About_us/News_Landing_Page/100-people-a-week--lose-a-limb-through-diabetes/ [lastreviewed 8/9/08].

6. van Houtum WH, Rauwerda JA, Ruwaard D, et al. Reduction in diabetes-related lower-extremity amputations in TheNetherlands: 1991–2000. Diabetes Care 2004; 27: 1042–1046.

7. Trautner C, Haastert B, Mauckner P, et al. Reduced incidence oflower-limb amputations in the diabetic population of a German city, 1990–2005: results of the Leverkusen AmputationReduction Study (LARS). Diabetes Care 2007; 30: 2633–2637.

8. Krishnan S, Nash F, Baker N, et al. Reduction in diabetic ampu-tations over 11 years in a defined U.K. population: benefits ofmultidisciplinary team work and continuous prospective audit.Diabetes Care 2008; 31: 99–101.

9. Larsson J, Apelqvist J, Agardh CD, et al. Decreasing incidence ofmajor amputation in diabetic patients: a consequence of a multidisciplinary foot care team approach? Diabet Med 1995; 12:770–776.

10. Holstein P, Ellitsgaard N, Olsen BB, et al. Decreasing incidenceof major amputations in people with diabetes. Diabetologia 2000;43: 844–847.

11. Calle-Pascual AL, Garcia-Torre N, Moraga I, et al. Epidemiologyof nontraumatic lower-extremity amputation in Area 7, Madrid,between 1989 and 1999. Diabetes Care 2001; 24: 1686–1689.

12. Eskelinen E, Eskelinen A, Albäck A, et al. Major amputation inci-dence decreases both in non-diabetic and in diabetic patients inHelsinki. Scand J Surg 2006; 95: 185–189.

13. Lipscombe LL, Hux JE. Trends in diabetes prevalence, inci-dence, and mortality in Ontario, Canada 1995–2005: a popula-tion-based study. Lancet 2007; 369: 750–756.

14. Dale AC, Vatten LJ, Nilsen TI, et al. Secular decline in mortalityfrom coronary heart disease in adults with diabetes mellitus:cohort study. BMJ 2008; 337: a236. doi:10.1136/bmj.39582.447998.BE.

15. Edmonds ME, Blundell MP, Morris ME, et al. Improved survivalof the diabetic foot: the role of a specialized foot clinic. Q J Med1986; 60(232): 763–771.

16. Rith-Najarian S, Branchaud C, Beaulieu O, et al. Reducing lower-extremity amputations due to diabetes. J Fam Pract 1998; 47:127–132.

17. Armstrong DG, Nguyen HC, Lavery LA, et al. Offloading the dia-

betic foot wound: a randomised clinical trial. Diabetes Care 2001;24: 1019–1022.

18. Katz IA, Harlan A, Miranda-Palma B, et al. A randomized trial oftwo irremovable off-loading devices in the management of plan-tar neuropathic diabetic foot ulcers. Diabetes Care 2005; 28:555–559.

19. Winell K, Niemi M, Lepantalo M. The national hospital dis-charge register data on lower limb amputations. Eur J VascEndovasc Surg 2006; 32: 66–70.

20. UK Prospective Diabetes Study (UKPDS) Group. Tight bloodpressure control and risk of macrovascular and microvascularcomplications in type 2 diabetes: UKPDS 38. BMJ 1998; 317:703–713.

21. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared withconventional treatment and risk of complications in patients withtype 2 diabetes (UKPDS 33). Lancet 1998; 352: 837–853.

22. Boyko EJ, Ahoroni JH, Cohen V, et al. Prediction of diabetic footulcer occurrence using commonly available clinical information.Diabetes Care 2006; 29: 1202–1207.

23. Leese GP, Reid F, Green V, et al. Predicting foot ulceration in dia-betes: validation of a clinical tool in a population-based study. IntJ Clin Pract 2006; 60: 541–545.

24. Leese GP, Schofield CJ, McMurray B, et al. Scottish foot ulcer riskscore predicts healing in a regional specialist foot clinic. DiabetesCare 2007; 30: 2064–2069.

25. Valk GD, Kriegsman DM, Assendelft WJ. Patient education forpreventing diabetic foot ulceration. A systematic review.Endocrinol Metab Clin North Am 2002; 31: 633–658.

26. Uccioli L, Faglia E, Monticone G, et al. Manufactured shoes inthe prevention of diabetic foot ulcers. Diabetes Care 1995; 18:1376–1378.

27. Reiber GE, Smith DG, Wallace C, et al. Effect of therapeuticfootwear on foot reulceration in patients with diabetes: a ran-domized controlled trial. JAMA 2002; 15: 287: 2552–2558.

28. Faglia E, Favales F, Aldeghi A, et al. Adjunctive systemic hyper-baric oxygen therapy in treatment of severe prevalently ischemicdiabetic foot ulcer. A randomized study. Diabetes Care 1996; 19:1338–1343.

29. Schofield CJ, Libby G, Brennan GM, et al. Mortality and hospital-isation in patients after amputation: a comparison betweenpatients with and without diabetes. Diabetes Care 2006; 29:2252–2256.

30. Aulivola B, Hile CN, Hamdan AD, et al. Major lower extremityamputation: outcome of a modern series. Arch Surg 2004;139(4): 395–399.

31. Resnick HE, Carter EA, Lindsay R, et al. Relation of lower-extremity amputation to all-cause and cardiovascular diseasemortality in American Indians: the Strong Heart Study. DiabetesCare 2004; 27: 1286–1293.

32. Tentolouris N, Al-Sabbagh S, Walker MG, et al. Mortality in dia-betic and nondiabetic patients after amputations performedfrom 1990 to 1995: a 5-year follow-up study. Diabetes Care 2004;27: 1598–1604.

33. Young MJ, McCardle JE, Randall LE, et al. Improved survival ofdiabetic foot ulcer patients 1995–2008, possible impact ofaggressive cardiovascular risk management. Diabetes Care 2008Aug 12. [Epub ahead of print.]

LEADER

Pract Diab Int October 2008 Vol. 25 No. 8 Copyright © 2008 John Wiley & Sons 299

CONFERENCE NOTICE

Association of British Clinical Diabetologists Autumn Meeting27–28 November 2008, Hotel Russell, London

For further details and to register please contact: Elise Harvey, Gusto Events Ltd, PO Box 2927, Malmesbury SN16 0WZ, UK. Tel: +44(0)7970 606962, e-mail: [email protected], website: www.diabetologists-abcd.org.uk

Ldr Leese 93.08.qxp 26/9/08 14:44 Page 3