FOOTPAD. S J Fratesi MD FRCS MMED June 2010 Quo Vadis? (where are we going?)

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1 FOOTPAD S J Fratesi MD FRCS MMED June 2010 Quo Vadis? (where are we going?)

2 8 commandments of foot care 1) Wash daily Thou shalt. 1) Inspect and lubricate daily 1) Diligent nail care 1) Proper fitting footwear 1) Regular activity and diet 1) Avoid common mistakes and be careful 7 ) Regular medical visits

3 FOOTPAD F..Foot O..Optimal O..Outcomes T.. Treatments P..People A.Algoma D.Diabetes

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5 Ontario Diabetes database Ø burden of disease prevalence, incidence, mortality Ø process of care * screening, access, glucose control Ø outcomes of care * complications, procedures Identify DM in special populations *quality of care index

6 Burden of Diabetes vs no Diabetes Significant increase in hospital admissions for acute MI Significant increase in stroke Leading cause of new dialysis Leading cause of limb amputations

7 Burden of Disease Two million Canadians have diabetes 31% increase in prevalence over 5 years primarily due to persons living longer with DM incident (newly diagnosed) cases steady

8 Mortality and Morbidity q life expectancy with DM is about 13 years less than without DM. 12% of men with DM and 18% of women need assistance with routine activities Three year mortality after first amputation is 50 %

9 Foot Disease is the Most Common Complication of Diabetes Leading to Hospitalization (Reiber and Kosak)

10 Independent Risk Factors for PAD* Relative Risk vs the General Population Reduced Increased 4.05 Diabetes 2.55 Smoking Hypertension Total cholesterol (10 mg/dl) * PAD diagnosis based on ABI <0.90. Newman AB, et al. Circulation. 1993;88:

11 15% of diabetics will develop a foot ulcer in their lifetime amputation in the diabetic is times higher than the non-diabetic every year 1 in every 250 diabetics will undergo amputation 85% of all amputations in diabetes are preceded by an ulcer

12 60 % of diabetics with foot ulceration have neuropathy without clinically significant arterial disease 20% have ulcers primarily due to arterial disease 20 % have ulcers secondary to a combination of both neuropathy and arterial disease

13 A proactive approach should reduce the burden of this disease, improve health through prevention of complications, and reduce the financial burden Bakker (2005) states that diabetic foot problems are a threat to every individual diabetes. Worldwide there are a million amputations per year in individuals with diabetes.

14 Complications of Diabetes 30% decrease in hospital admissions for elevated blood sugar levels 75% decrease in admissions for low blood sugar levels

15 Foot care is often described as the Cinderella complication of diabetes. Prevention and ulcer treatment may be based on local custom and practice Many false perceptions about diabetic foot problems, how to recognize and treat Urgent need for a systematic review of the evidence to inform practice, to highlight the steps that can be taken to prevent amputation, and to improve care.

16 The number of individuals with diabetes in Canada documented in 2005 surpassed the levels predicted for year 2030 (Lipscombe 2007). Sixty percent of all amputations are in patients with diabetes, many of which are preventable. Northern Ontario has several cluster areas of increased diabetes and diabetes-associated complications.

17 The complication rate of diabetes is not well monitored in Canada (Harris 2003) Canadians with diabetes are not well monitored for foot conditions Globally, there is no standardization of primary foot care in diabetes.

18 There is significant variability in foot care assessment and risk classification potentially leading to inappropriate care. Thompson (2005)

19 Almost 2 million Canadians have diabetes In amputated diabetics 50% develop ulcers in the contralateral limb <2 years 50% contralateral amputation within 5 years 3 year mortality after 1st amputation..50%

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21 Reflection Reflection as a method of learning and quality improvement (multi-professional) Reflection in Action Reflection on Action

22 Care of the foot with diabetes (Algoma) Ø Is there a problem? Ø Why does it exist? Ø What is the cause of the problem? Ø Is the problem preventable? Ø Is the problem modifiable? Ø What can be done to make it better?

23 Good Health Outcomes in Diabetes (GHOD SCORE) Process outcomes BP within 6 mo HbA1c within 6mo Lipids annually Albuminuria annually Foot exam within 1yr ( From 6 months) Eye exam within 1yr ( from 2yrs) On ACE/ARB On ASA/antiplatelet On Statins Clinical outcomes BP within 6 mo and <=130/80 mmhg HbA1c within 6 mo and <=.07 Lipids annually and LDL < 2.5

24 Where s the evidence? Lack of evidence affects the treatment of established foot ulcers Most carried out in secondary care settings Well-designed multi-center studies, with sufficient numbers of similar ulcers and appropriate randomization needed

25 Major predisposing factors Neuropathy PVD Limited joint mobility High plantar pressure Bony deformity History of previous ulceration Visual or functional impairment

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44 Common sites develop over bony prominences

45 The process can get out of hand

46 The above is both livable and workable

47 There is strong evidence to support foot care is best done with a multidisciplinary approach The majority of amputations begin as an ulcer 85% of ulcers may be prevented.

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49 Position statement 2005 IDF advocated for annual foot inspection, identification of the foot at risk, education of both professionals and individuals with diabetes, proper footwear as well as rapid treatment of all foot pathology.

50 Why guidelines work St Vincent Declaration (UK ) 50% reduction LEAP Program (USA) Annual exam to assess risk Intensive follow-up/education of at risk Prompt referral to multidisciplinary team

51 FOOTPAD: Foot care Optimal Outcomes and Treatment for Patients in Algoma with Diabetes Program

52 FOOTPAD initiative Establish a comprehensive, practical and evidence-based program for optimal foot care for all patients with diabetes in Algoma district. The mission statement adopted was FEET, support for life. It was hoped that a proactive approach to diabetic foot care would allow the people of Algoma access to a consistent and multidisciplinary foot care service including preventative measures and education.

53 Neuro assessment is pivotal Grade A recommendation to regular foot inspection for sensation and circulation. This is best done by testing the sensation with a monofilament or biothesiometer or tuning fork, palpation of pulses, inspection of deformity

54 Algoma district initiative The premise of FOOTPAD is that many foot related problems in diabetes are PREDICTABLE and therefore, PREVENTABLE. Early intervention in the insensate foot (PREDICTABLE) will result in less diabetic foot-related problems (PREVENTABLE). Fewer amputations will lower the burden of this health problem on our health care system. Even a trivial callus or blister should not be ignored.

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56 FOOTPAD Patient centered Community oriented Multi-professional Standardized Seamless Evidence based Electronically supported

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58 Basic assessment tool The basic sixty second foot exam (Armstrong 1998) with a few simple questions to answer with guidelines on clinical examination and documentation, including use of the 10 g monofilament test (Semmes-Weinstein monofilament test). This is a simple process of looking, feeling, testing and documenting as outlined in the protocol document

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60 Advanced assessment tool A checklist assessing the presence, absence and nature of pain, pulsation and structural deformity. As well, capillary refill, skin condition and colour are described with the provided checklist

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62 FOOTPAD was developed as both an educational tool and evidencebased program for primary foot care in diabetes. FOOTPAD was designed to show how evidence fashions best practice guidelines in diabetes

63 FOOTPAD will teach practitioners how to predict with a view to prevent. FOOTPAD is a sound, locally adaptable, evidence based guideline for foot care in diabetes. Health care professionals are encouraged to use it as best practice and as part of their continuing professional development.

64 85% of leg amputations in the diabetic preceded by a foot ulcer Major cause of a diabetic related hospital admission is a foot related problem

65 Multifactorial etiology of diabetic foot ulcer neuropathy Arterial insufficiency impaired cell immunity Non-compliance diabetic foot ulcer infection trauma

66 Diabetic ulcers

67 Diabetic neuropathy Skin abnormality,immune deficiency poor circulation Continuous/repetitive trauma Foot deformity/abnormal pressure points

68 METARSAL HEAD PROMINENCE AND ULCERATION ulceration is over the plantar surface of the metatarsal heads.

69 HAMMER-TOE DEFORMITY Claw-toe deformity with loss of function of intrinsic muscles of foot

70 CHARCOT'S FOOT Progressive neuropathy + Repetitive trauma + osteoporosis

71 Charcot's foot

72 ISCHEMIC FOOT ULCER This patient has previously had most of the toes of this foot removed because of gangrene but has failed to heal one of the amputation sites due to persistent ischemia which originated in the calf arteries.

73 ISCHEMIC FOOT ULCER

74 Diabetic ulcer risk Peripheral neuropathy Foot deformity Limited joint movement Elevated plantar pressure Prior ulcer/amputation Peripheral vascular disease Susceptibility to infection

75 Insensate foot

76 Tissue loss in the diabetic foot High foot pressure Callus/trauma ulceration Diabetic foot amputation Failure to heal infection

77 Amputations in Persons with DM

78 Footpad in holding pattern????? Footpad audit after 18 month launch

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84 The NICE Guidelines There is level 1 evidence to support recall and regular review as part of ongoing care in the management of foot care in diabetes. As part of that review, trained personnel should establish and document risk There is level 1 evidence to support structured education in diabetes as part of foot examination and monitoring

85 EVIDENCE based medicine Only two recommendations were found based on level 1 evidence. These included the importance of a physical examination to assess risk (should be performed by a health care professional) and that all people with diabetes should receive basic foot care education. All other recommendations were based on level 4 evidence

86 Diabetes increases the risk of foot ulceration. Appropriate screening with intervention measures may reduce this risk. Screen all patients with diabetes to assign the patient to a risk category that dictates both the method and frequency of foot interventions. (Rollins 2000).

87 These interventions may reduce the risk of ulceration and possible amputation and are supported by a varying degree of evidence (Singh 2005). include education of both patient and allied health care workers optimizing glycemic control, smoking sensation possible prescription of footwear.

88 More evidence to support care of the diabetic foot in the community (primary care ) directed at ulcer prevention Recommendations based on evidence regular annual foot examination detection of feet at risk of ulceration appropriate education.

89 Initial diabetes assessment Check for foot deformity Check for pulses check for sensation (10g or vibration) Check shoes MUST BE DONE AT INITIAL ASSESSMENT THEN YEARLY Assign risk status( OOOPPS!!!!)

90 Prevention Check feet at every visit shoes/socks off Neurological examination.pinprick, reflexes, tuning fork, monofilament test* Vascular assessment.. popliteal pulse, ABI. Evaluate according to risk status

91 Risk status qpatient currently does not have an ulcer LOW - risk normal sensation, pulses, no deformity MODERATE -neuropathy or absent pulse or other risk SEVERE -neuropathy or absent pulse, deformity or previous ulcer

92 Risk assessment Nice guidelines LOW -annual assessment, education, footwear MODERATE HIGH assessment -3-6 month assessment -foot education/inspection -evaluate foot wear /circulation -1-3 months -foot assessment /circulation -intensified foot care education, specialized footwear, skin and nail care

93 Risk Identification Fundamental for effective preventive management in people diabetes The risk of ulcers or amputations is increased diabetes X 10 years male poor glucose control cardiovascular, retinal, or renal complications

94 Major predisposing factors Neuropathy PVD Limited joint mobility High plantar pressure Bony deformity History of previous ulceration Visual or functional impairment

95 Assessment of foot risk The classification of the foot into low, medium and high risk was supported by a grade C recommendation. Regular review by a foot protection team based on risk at 3, 6, and 12 monthly intervals was supported by grade C/D recommendations.

96 Five Key Risk Factors Presence or history of foot ulcers Protective sensation Structural abnormalities Circulation Self-care knowledge and behaviour Primary care can make a difference

97 Screening annual screen of everyone with diabetes for foot risk by inspection, palpation of pulses, and insensitivity to the 10g nylon monofilament is reinforced by this guideline (A). takes only minutes requires no expensive equipment doesn't matter who does it as long as it gets done.

98 Accommodative shoes Getting the right fit Major cause of trauma Ulcers often from shoes.constant pressure of 5-7 pounds per square inch over a bony prominence leads to necrosis within 7 hours

99 At risk foot at-risk individuals should receive extra foot care education and frequent review to prevent the development of ulceration. This strategy reduces morbidity and is cost- effective. (Ib)

100 Patient Education EMPOWERMENT Goal Oriented Problem Centered Offers Feedback Group Discussion Varied Presentation

101 Wagner s classification of foot ulcers Grade 0..the at risk foot Grade 1.superficial ulcer Grade 2.penetrating ulcer Grade 3 complicated by infection Grade 4.gangrene not requiring total foot amputation Grade 5 gangrene requiring leg amputation Above classification assessed in context of sufficient blood supply to heal

102 SAH Topical Wound Overview RED YELLOW BLACK assessment after proper cleansing

103 Where do you start?

104 6 simple questions Where is the infection/ulcer? How bad is it? How did it get there? What can be done to make it better? What can be done to make sure it does not recur? What are the co-morbid conditions?

105 Factors that may affect healing in the diabetic patient: Metabolic control Infection Ischemia Continuing trauma Patient education and compliance Concurrent medical problems/medication Wound environment Multidisciplinary foot care program

106 Atherosclerosis of the lower limb in the diabetic: Diabetes>20 years > 50% lose peripheral pulse Diabetics have small vessel disease plus more trifurcation disease than non-diabetics Distal revascularization has saved many diabetic limbs Smoking + diabetes = amputation

107 Wound Etiology

108 Case study 70-year-old male Previous leg ulcer Smoker claudicates Absent pulse What is your most likely diagnosis?

109 Arterial ulcer in a diabetic? OR diabetic ulcer in an arteriopath? Does it matter? Is RX same?

110 Skin breakdown due arterial causes.risk factors Diabetes Tobacco Hyperlipidemia Hypertension Obesity Cardiac disease Renal disease COPD Coagulation disorders

111 Arterial wound management objectives Keep clean Keep dry? Debride necrotic tissue Manage exudate by hydration Protect from mechanical/thermal trauma Protect from infection

112 Initial conservative measures General measures Loose weight Exercise QUIT SMOKING Pharmacologic agents.trental,adalat,asa, Ischemic bed routine

113 Investigations History Clinical examination Non-invasive arterial study(abi<.3,>.6) Arteriogram(done only if surgery is entertained)

114 Clinical assessment( Documentation of pulses/intensity Skin nutrition,ulcer, fissure,cold paronychia,temperature of foot Pallor with elevation/rubor with dependency Prolonged venous filling time

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117 ANGIOGRAPHY IN DIABETES

118 Surgery Angioplasty Angioplasty/stent Bypass procedure inflow/outflow*

119 Neurological assessment of diabetic ankle reflexes vibration sensation pain sensation Diminished protective sensation to monofilament testing (10 gram / 5.07 mm Semmes-Weinstein)?

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121 USE OF 10-GRAM MONOFILAMENT

122 Factors to enhance wound environment in diabetic patients with foot ulceration: Aggressive debridement to remove necrotic tissue and slough Control of infection Optimize oxygenation Avoidance of further trauma Ulcer dressings and topical wound therapy

123 Infections in diabetic foot ulcers: Foot infection is a common cause for diabetic hospitalization An altered immune responses may mask the clinical severity of infections. Less than 50 % with limb threatening infections have a significant fever or elevated WBC count. ice berg effect quite common

124 Infected diabetic foot ulcers: Deep tissue infections: mono-microbial infections occur in only about 20% of cases on average, deep tissue infections will grow five different bacterial species Superficial infections: milder infections have fewer bacteria: mean of 2.1 different bacterial species gram positive cocci most common bacteria but are sole pathogen in less than 50% of patients

125 Infected diabetic foot ulcers: The importance of aerobic/anaerobic culture The more serious the infection, the higher the probability of multiple organisms particularly if a deep infection Milder infections tend to have fewer organisms particularly if superficial Gm(+) cocci is the most common but is the lone ranger in<50%

126 Diabetic foot ulcers and use of antiseptics: Antiseptics are reactive chemicals that indiscriminately destroy bacteria as well as healthy granulation tissue in wounds. There is no magical, topical antiseptic that will selectively kill bacteria without harming healing cells in the wound base.

127 Wound culture techniques: surface cultures from diabetic wounds may not correlate well with deeper culture techniques Deep needle aspiration via non-infected area usually correlates with deep infections The most reliable cultures taken from biopsy or swab after the surface exudate has been removed. Important to distinguish contamination from infection Organisms usually poymicrobial

128 Wound Assessment All wounds should be probed for extent and hidden sepsis

129 Why a moist wound environment? Proven reduction in infection rate Allows natural enzymes to dissolve debris Promotes wound healing (growth factors) Helps mould wound Prevents re-injury of a dry dressing

130 Osteomyelitis in the diabetic foot Initially plain X Ray may be normal Technetium bone scans 70% reliable with lower specificity Addition of Gallium improves the sensitivity and specificity Indium WBC scanning is best scanning method but more expensive and less readily available. MRI probably best test of bone infection.

131 Osteomyelitis in diabetic foot

132 The role of foot soaks in diabetic foot care Should NOT be done a definite NO... NO Macerates tissues Increases infection Tendency to thermal injury/damage normal healthy tissue

133 A foot soak gone bad maceration

134 Diabetic foot ulcers: newer therapies Recombinant human growth factor therapy (Regranex*) Bio-engineered human skin replacements (Dermagraft*) VAC therapy (KCI) These do not replace nor are they first line strategies

135 Diabetic wound dressings Promote debridement,repair and growth Reduce the pain Absorb any exudate Maintain humidity but not mascerate Keep out the bacteria

136 HOW MUCH DOES IT COST? WHO IS GOING TO PAY?

137 Wound care management Restoration OR maintenance? Etiology, wound management, local skin care, nutrition Damage control internal factors, environmental factors behavioral factors

138 The importance of Prevention Identify the patient at risk Use of established assessment tools(braden and Norton scales) Astute skin care Minimize the aggravating factors

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146 Wound care protocols all the standard issue discussed plus. Bioengineered tissue Growth factors

147 DERMAGRAFT* APPLICATION

148 Diabetic foot ulcers and hyperbaric oxygen therapy (HBOT): Several studies have shown increased limb salvage withthe use of hyperbaric oxygen in selected patients withinfected diabetic foot ulcers. In general, patients in these studies had deep infection with good arterial supply in whom HBOT was used as an adjunctive treatment with standard wound care therapy.

149 Assessment of the diabetic foot General / specific assessment of the patient Documentation & exploration of wound Assess the circulation Debride as necessary Xray as necessary C& S of wound Formulate treatment plan/wound care protocol Follow-up/referral as necessary

150 Initial Assessment Total Care Considerations Wound Evaluation General Health Assessment Pressure Relief Assessment Psychosocial/Environment Expectations/Goals Defined Comfort/Pain Knowledge/Education Prevention

151 Diabetic foot assessment The importance of structural deformity (Charcot, hammer or claw toe),limited joint mobility, neuropathy and impaired circulation The physical examination must include a thorough inspection, vascular assessment neuro assessment and check out the footwear

152 Management of the ulcer Debride..gets rid of the necrotic tissue/callus.allows proper assessment.increases cytokines in the wound(platelets) Off-Load the pressure.reduce friction and shear forces prescription footwear, orthotics,ortho wedge boots,silicone socks Total contact casts and removable casts

153 Ulcer management Use of antimicrobials..the importance of recognizing and treating the infected ulcer.in pt vs out patient therapy oral vs IV therapy Wound care Avoid abuse of antibiotic topical Tx Extremely important education and followup

154 Wound care protocols standard wound care management protocols Bioengineered tissue Growth factors

155 Early treatment of the diabetic foot improves function and quality of life infection control maintain health status reduce costs

156 Steps in Saving the Diabetic Foot Patient Education Identification of Risk Factors Recognition and Treatment of etiology Wound Management Augmentative Interventions

157 Patient Education Goal Oriented Problem Centred Offers Feedback Group Discussion Varied Presentation

158 Diabetic ulcer risk Peripheral neuropathy Foot deformity Limited joint movement Elevated plantar pressure Prior ulcer/amputation Peripheral vascular disease Susceptibility to infection

159 Identification of Risk Factors prior diabetic ulcer advancing age peripheral vascular disease diabetic neuropathy

160 Identification of Risk Factors Peripheral Vascular Disease Structural Deformity

161 Identification of Risk Factors Peripheral Neuropathy - motor - autonomic - sensory

162 Identification of Risk Factors Peripheral Sensory Neuropathy Autonomic Peripheral Neuropathy

163 Underlying Etiology Extrinsic Trauma Foreign Body Improper Footwear Poor Pressure Relief Surfaces Intrinsic Limited Joint Mobility Foot Deformity Foot Mechanics Neoplasm Infection Ischemia

164 Recognition and Treatment of Underlying Etiology Intrinsic Cause Foot Mechanics Limited joint mobility Foot deformity

165 Principles of Wound Management Debridement Pressure Reduction Removal of Bacterial Burden Promote Healing

166 Wound Management Pressure Reduction Remove Bacterial Burden

167 Augmentative Interventions Therapeutic Off-Loading Devices Crest Pad

168 Insoles and Orthotics Custom Footwear Off-the-Shelf Footwear

169 Diabetic Foot Ulcers are Predictable and Preventable

170 General management approach Effective care involves a partnership between patients and professionals, and all decision making should be shared Arrange recall and annual review as part of ongoing care As part of annual review, trained personnel should examine patients feet to detect risk factors for ulceration and document findings.

171 Examination of patients feet should include: testing of foot sensation using a 10 g monofilament or vibration palpation of foot pulses inspection of any foot deformity and footwear

172 Peters and Lavery (2001) provide an excellent review on the topic and conclude based on evidence that a foot risk classification will predict ulceration and amputation in diabetic feet and may function as a tool to lower extremity amputations. an increase in morbid events throughout progression through the classification system.

173 In Canada, the gold standard of diabetes care is the maintenance of proper glycosated hemoglobin levels and glucose control. The major complications of diabetes including renal failure, heart disease and ophthalmic complications receive increased attention. However, oral care and foot care have not.

174 At each review: determine risk inspect patient s feet consider need for vascular assessment evaluate and ensure the appropriate provision of intensified foot care education specialist footwear and insoles skin and nail care Ensure special arrangements for those people with disabilities or immobility

175 The high-risk group is 34 times more likely to ulcerate and 17 times more likely to have an amputation compared to the low-risk group. The high-risk group is also more likely to have a longer history of diabetes, worse glycemic control, more neuropathy, and increased plantar pressure.

176 The high risk ulcer group is also more likely to be male, alcohol users, and have other end organ diabetic complications including renal failure, retinopathy or cardiac disease. Neuropathy is the pivotal risk factor (Crawford 2007).

177 The FOOTPAD template for diabetes management was changed. All diabetes patients will be assigned a risk classification for foot disease and be reviewed by automatic recall as per the electronic medical record based on the revised template

178 Classify foot risk as: at low current risk at medium risk at high risk ulcerated foot

179 Care of people at low current risk of foot ulcers (normal sensation, palpable pulses) Annual assessment including foot care education with each person

180 Care of people at medium risk of foot ulcers (neuropathy or absent pulses or other risk factor) Arrange regular review, 3 6 monthly, by foot protection team At each review: inspect patient s feet consider need for vascular assessment evaluate footwear enhance foot care education previous foot ulcer or deformity or skin changes manage as high risk

181 Care of people at high risk of foot ulcers (neuropathy or absent pulses plus deformity or skin changes or previous ulcer) Arrange frequent review (1 3 monthly) by foot protection team

182 How can we improve????? 1)Better off loading contact casting 2)Better funding shoes/orthotics/walking boots 3)Increased community service personnel and funding 4)More aggressive vascular intervention 5)More aggressive /earlier bone intervention

183 Exciting new horizon Dr T Best surgical intervention in the the treatment of diabetic neuropathy..supported by a PSI grant..peripheral nerve decompression for the treatment of painful peripheral sensorimotor polyneuropathy in type 1 and type 2 diabetes

184 Inclusion Criteria c >18 years of age c Type 1 or 2 diabetes mellitus c Symptoms of paresthesia (including burning pain) or numbness present symmetrically in both feet, determined to be on a peripheral nerve basis c HbA1c < 7 x 2 in the past 12 months Exclusion Criteria c Other types of diabetes mellitus (gestational, drug-induced) c Causes of neuropathy than diabetes (vasculitis, HIV, renal failure, alcohol abuse) c Symptomatic lumbosacral spine disease c Symptomatic lower extremity vascular disease c Previous foot ulceration or amputation; other contradictions to surgery c History of Peripheral Arterial Disease c HbA1c >7.1 c Inability to give consent, pregnant women, prisoners, nonenglish speakers who require an interpreter

185 Smoking + diabetes = amputation

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