MALIGNANT DIABETES AND ASSOCIATED MORTALITY

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MALIGNANT DIABETES AND ASSOCIATED MORTALITY

• CAN WE DO ANYTHING ABOUT IT?

Terri DeJohn, M.D. Medical Director Hyperbaric
Medicine and Wound Treatment Center
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OBJECTIVES

• Identify factors which contribute to increased
  mortality in the DFU patient.
• Learn who to call for help and when to make that
  call.

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DIABETES IS INCREASING

• 26 million people in the U.S. have diabetes
• 1.9 million diagnosed in 2010
• 15 will develop Diabetic Foot Ulcers (DFU)

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AMPUTATIONS

• 15 of DFUs End in Amputation

• 71 are toe, TMA and Symes amputations
• 82 decrease in BKA or AKA

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AMPUTATION INCIDENCE IN MINORITIES

• per 10,000 Diabetics

MEN have twice the incidence of amputation as
women in all races
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MALIGNANT DIABETES
Armstrong DG. Int Wound J. 2007Dec4(4)286-7.
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MORTALITY RISK IMPROVES WITH TREATMENT BY A
MULTI-DISCIPLINARY TEAM

• In 5 Years
• Living
• Dead

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MULTIFACTORIAL ETIOLOGY

• Diabetes

Amputation
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MULTIFACTORIAL ETIOLOGY

• Diabetes

Amputation
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MULTIFACTORIAL ETIOLOGY

• 
  Amputation
• Vascular
  Disease
• Infection
• Ulceration
• Deformity

Neuropathy
Diabetes
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LIMB SALVAGE TEAM

• Multiple problems contribute to critical wounds
  and potential amputation.
• Multiple doctors with expertise in their area
  working together to save a leg.

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MULTIFACTORIAL ETIOLOGY

• 
  Amputation
• Vascular
  Disease - CV
• Infection - IMMUNE
• Ulceration - DERMATALOGIC
• Deformity- ORTHOPEDIC

Neuropathy - NEUROLOGIC
Diabetes - ENDOCRINE
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• OUTCOMES OF
• MULTIDISCIPLINARY TEAMS

AUTHOR JOURNAL OUTCOME
Najarian J.Fam Prac. 1998 48 Amputations
Patout Diabet Care 2000 49 Ulcerations 79 Amputations 89 Admissions
Cherry Diab Tech Ther 2002 32 Admissions 34 ER Visits 49 OP Visits
Lavery Diab Research Clinic Pract 2005 52 Amputations 38 Admissions 28 LOS
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Moving from aWound Clinicor Lone Practitioner
to a Limb Salvage Team
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Rapid Referral to Multi-disciplinary Team

• Referral before 25 days resulted in a 79
  reduction in amputations.
• vanAcker, et al, DFCon2011
  Establishing a National Diabetic
  Foot Model

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RECOMMENDATIONS FROM EVIDENCE

• CONSENSUS RECOMMENDATIONS ON ADVANCING THE
  STANDARD OF CARE FOR TREATING NEUROPATHIC FOOT
  ULCERS IN PATIENTS WITH DIABETES
• APRIL 2010 OSTOMY AND WOUND MANAGEMENT

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TREATMENT OF DFUs

• DEFINE
• DISCUSS
• DEBRIDE (VESSELS AND BED)
• DEBUG
• DECIDE
• DE-LOAD

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DEFINE

• SKIN AND ULCER EXAM
• Skin
• Sensation
• Deformity
• Ulcer Size, Location, Base, Wound edge,
  Tunnel, Necrosis

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DEFINE

• INFECTION
• Drainage
• Odor
• Redness
• Swelling
• Probe Bone
• If suspicious ESR, CRP (If both are normal,
  Osteomyelitis is unlikely), Culture

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IMAGING

• Plain films
• MRI or CT

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VASCULAR EVALUATION

• A tiered approach is recommended
• 1. Pulses, ABI, and/or TBI
• 2. Segmental pressure volume, SPP and TcPO2
• 3. Vascular consultation

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TISSUE HYPOXIA

• TcPO2 lt 40mmHg suggests impaired healing
• Risk of amputation is 161 times greater if TcPO2
  lt20 rather than TcPO2 gt40
• Risk amputation is 55 time greater if
  ABI is lt0.45 rather than gt0.7

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DEFINE

• LABS
• CBC
• HgA1c
• Cholesterol, HDL, LDL
• Homocysteine (Hcy)

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Effects of Hyperglycemia on Cells

• 1. Decreased proliferation and differentiation
  of keratinocytes (1)
• 2. Inhibition of fibroblast proliferation (2)
• 3. Decreased response of cells to growth factors
  (2,3)
• 4. Decreased migration of keratinocytes and
  fibroblasts (4)
• (1) Sparvchikov N, ed al. Diabetes 2001 50
  1627-635
• (2)Hehenberger K, et al. Cell Biochem Funct
  1997 15 197-201
• (3)Fard A, et al. Arterioscler Throm Vasc
  Biol 2000 20 2039-2044
• (4)Lerman OZ, et al. Am J Pathol 2003
  162303-312

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HEMOGLOBIN A1C WOUND HEALING

• Methods A retrospective analysis of data
  gathered from multi-center, controlled,
  prospective, randomized FDA approved clinical
  trials is being conducted.
• Results The final linear regression model
  (Plt0.0001) found that higher HgbA1C levels were
  associated with lower percentages of wound
  healing (P0.05).
• For every 1 increase in HgbA1c there is a
• decrease of 3 in expected healing area
• Hanft J, et al, South Miami Hospital Harvard
  Medical School, APMA Scientific Meeting Abstract,
  2009

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Wound Healing in the Diabetic
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DEFINE

• LABS
• CBC
• HgA1c
• Cholesterol, HDL, LDL
• Homocysteine (Hcy)

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Homocysteine (Hcy)

• Known risk factor for atherosclerotic vascular
  disease and is an inhibitor of nitric oxide (NO)
  bioactivity
• ? Hcy was observed in
• 50 of patients with chronic wounds
• 63 of patients with diabetic, neuropathic ulcers

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• Figure 6.

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TREATMENT OF HYPER- Hcy

• METANX
• L-methylfolate
• Pyridoxal 5'-phosphate
• Methylcobalamin
• Results in 3Xs lower serum Hcy

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DEFINE

• NUTRITION
• Nutrition Screen
• Albumin, Pre-Albumin, Transferrin
• CONSIDER PROTEIN SUPPLEMENTS
• .5 - .75 gm / kg of body weight

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DEFINE

• SMOKING
• Nicotine
• Cyanide
• Carbon Monoxide
• CONSIDER E-CIGARETTE

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DEFINED DISEASE PROCESSES

• ULCER
• DEFORMITY
• INFECTION
• VASCULAR STATUS
• DIABETIC CONTROL
• NUTRITIONAL STATE

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DEFINE DISCUSS

• Initial definition to determine what issues
  contribute to the problem
• Discuss with appropriate specialists

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DEFINE AND DISCUSS
Vascular surgeon Ortho/ Podiatry/
Pedorthotist Infectious Disease Endocrinologist/
Diabetic Ed Dietician

• Tissue Hypoxia
• Deformity
• Infection
• Diabetic Control
• Nutrition

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DEBRIDE

• Debridement
• Sharp
• Mechanical
• Chemical
• Autolytic

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DE-BUG
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BIOFILMS

• Biofilms are present in 60 of chronic wound
  biopsies
• Only 6 of Acute Wound Biopsies
• Biofilms retard wound healing
• Schierle WWR 172009

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BIOFILMS

• Biofilms induce a chronic inflammatory response
• Reactive Oxygen Species (ROS)
• Proteases ( MMP, neutrophil elastase)
• Chronic inflammation leads to damage of proteins
  that are essential for healing.
• Extracellular Matrix Proteins
• Growth factors and receptors

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DECIDE WHAT DRESSING

• Wound care dressing orders for 202 patients
  receiving home health or HMO care
• 42 Wet-to-Dry
• 7.5 Enzymatic
• 7 Dry Gauze
• Cowan L, Stechmiller J. Advances in Skin
  and Wound Care Dec, 2009

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DECIDE WHAT DRESSING

• TO DRY
• Alginates
• Foams
• ABDs
• Polymers
• NPWT

• TO MOISTEN
• Hydrogel
• Medihoney
• Ointments

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DECIDE WHAT DRESSING

• ANTIMICROBIAL
• Silver
• Iodosorb
• Medihoney

ACTIVE DRESSING Collagens Regranex Skin
Substitutes
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DE-LOAD (Off- Load)

• OFF LOADING DEVICES

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OFF LOADING

• TOTAL CONTACT CASTING
• Only device proven to effectively off load
• REMOVABLE DEVICES ARE REMOVED
• Only 28 of daily activity done with device
• Armstrong, Diabetes Care 2003

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QUALITY CARE

• BENCHMARKING
• Off Loading is the 1 Benchmark
• Diabetic Control
• Vascular Exam

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DECIDE _at_ 4 WEEKS
A 50 reduction in wound area at 4 weeks is a
surrogate marker predictive of wound healing.
Area Reduction at 4 weeks
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• Percentage of Area Reduction
• (A1 - A2) A1 x 100
• A Length x Width

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FAILURE TO ACHIEVE 50 CLOSURE _at_ 4 WEEKS
REQUIRES ADVANCED THERAPIES
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FAILURE ADVANCED TX

• Negative Pressure
• Wound Therapy

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FAILURE ADVANCED TX

• Living Skin Substsitutes

Living Skin Substitutes
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FAILURE ADVANCED TX

• Hyperbaric Oxygen Therapy

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FAILURE ADVANCED TX

• Deformity can be mitigated with appropriate
  footwear.
• Severe deformity may be corrected with surgery

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MOVING FORWARD

• LEAVING EXPERT OPINION BEHIND
• GOING TO EVIDENCE BASED RECOMMENDATIONS TO
  DEVELOP PROTOCOLS

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DFUS ARE HARD TO HEAL

• Even with adequate blood flow
• 24 of patients closed at 12 weeks
• 31 at 20 weeks
• Using standardize protocols in a multi-center
  wound care network
• 68 healing rate at 20 weeks

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