MALIGNANT DIABETES AND ASSOCIATED

MORTALITY

CAN WE DO ANYTHING ABOUT IT?

Terri DeJohn, M.D.Medical Director

Hyperbaric Medicine and Wound Treatment Center

OBJECTIVESOBJECTIVES

Identify factors which contribute to increased mortality in the DFU patient.

Learn who to call for help and when to make that call.

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)

AMPUTATIONSAMPUTATIONS

15% of DFU15% of DFU’’s End in s End in AmputationAmputation

per 10,000 Diabetics

AMPUTATION INCIDENCE IN MINORITIES

MEN have twice the incidence of amputation as women in all races

Armstrong DG. Int Wound J. 2007;Dec;4(4):286-7.

MALIGNANT DIABETES

MORTALITY RISK IMPROVES MORTALITY RISK IMPROVES WITH TREATMENT BY A WITH TREATMENT BY A

MULTI-DISCIPLINARY TEAMMULTI-DISCIPLINARY TEAM

In 5 Years

Living

Dead

MULTIFACTORIAL ETIOLOGY

Diabetes

Amputation

MULTIFACTORIAL ETIOLOGY

Diabetes

Amputation

MULTIFACTORIAL ETIOLOGY

Amputation

Vascular Disease

Infection

Ulceration

Deformity

Neuropathy

Diabetes

LIMB SALVAGE TEAM

MULTIFACTORIAL ETIOLOGY

Amputation

Vascular Disease - CV

Infection - IMMUNE

Ulceration - DERMATALOGIC

Deformity- ORTHOPEDICNeuropathy - NEUROLOGIC

Diabetes - ENDOCRINE

OUTCOMES OFMULTIDISCIPLINARY TEAMS

AUTHOR JOURNAL OUTCOME

Najarian J.Fam Prac. 1998 48% Amputations

Patout Diabet Care 200049% Ulcerations79% Amputations89% Admissions

CherryDiab Tech Ther

2002

32% Admissions34% ER Visits49% OP Visits

LaveryDiab Research

ClinicPract 2005

52% Amputations38% Admissions28% LOS

Moving from aWound Clinic

or Lone Practitioner

to aLimb Salvage

Team

Rapid Referral to Multi-disciplinary

TeamReferral before 25 days resulted in a 79% reduction in amputations.

•vanAcker, et al, DFCon2011 Establishing a National Diabetic Foot Model

RECOMMENDATIONS RECOMMENDATIONS FROM EVIDENCE 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

TREATMENT OF DFUTREATMENT OF DFU’’ssDEFINE

DISCUSS

DEBRIDE (VESSELS AND BED)

DEBUG

DECIDE

DE-LOAD

DEFINEDEFINE

SKIN AND ULCER EXAM

• Skin

• Sensation

• Deformity

• Ulcer: Size, Location, Base, Wound edge, Tunnel, Necrosis

DEFINEDEFINEINFECTION

• Drainage

• Odor

• Redness

• Swelling

• Probe Bone

• If suspicious: ESR, CRP (If both are normal, Osteomyelitis is unlikely), Culture

IMAGINGIMAGING

Plain films

MRI or CT

VASCULAR VASCULAR EVALUATIONEVALUATION

A tiered approach is recommended :

1. Pulses, ABI, and/or TBI

2. Segmental pressure volume, SPP and TcPO2

3. Vascular consultation

TISSUE HYPOXIATISSUE HYPOXIA

TcPO2 < 40mmHg suggests impaired healing

Risk of amputation is 161 times greater if TcPO2 <20 rather than TcPO2 >40

Risk amputation is 55 time greater if ABI is <0.45 rather than >0.7

DEFINEDEFINE

LABSCBC

HgA1cCholesterol, HDL, LDLHomocysteine (Hcy)

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; 162:303-312

HEMOGLOBIN A1C HEMOGLOBIN A1C & WOUND HEALING& 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 (P<0.0001) found that higher HgbA1C levels were associated with lower percentages of wound healing (P=0.05).

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

Wound Healing in the Diabetic

Impact of HgA1c on Wound Healing

0

10

20

30

40

50

60

70

Worsening Decreasing

HgA1c

Per

cen

tag

e o

f H

eali

ng

Control

Control

Dermagraft

Apligraft

DEFINE

LABSCBC

HgA1cCholesterol, HDL, LDLHomocysteine (Hcy)

Homocysteine (Hcy)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

•Figure 6.

TREATMENT OF TREATMENT OF HYPER- HcyHYPER- Hcy

METANX

L-methylfolate

Pyridoxal 5'-phosphate

Methylcobalamin

Results in 3X’s lower serum Hcy

DEFINEDEFINENUTRITION

• Nutrition Screen

• Albumin, Pre-Albumin, Transferrin

CONSIDER PROTEIN SUPPLEMENTS

.5 - .75 gm / kg of body weight

DEFINEDEFINESMOKING

• Nicotine

• Cyanide

• Carbon Monoxide

CONSIDER E-CIGARETTE

DEFINED DISEASE DEFINED DISEASE PROCESSESPROCESSES

ULCER

DEFORMITY

INFECTION

VASCULAR STATUS

DIABETIC CONTROL

NUTRITIONAL STATE

DEFINE & DISCUSSDEFINE & DISCUSS

Initial definition to determine what issues contribute to the problem

Discuss with appropriate specialists

DEFINE AND DISCUSSDEFINE AND DISCUSS

Tissue Hypoxia

Deformity

Infection

Diabetic Control

Nutrition

Vascular surgeon

Ortho/ Podiatry/ Pedorthotist

Infectious Disease

Endocrinologist/ Diabetic Ed

Dietician

DEBRIDEDEBRIDE

DebridementDebridement

–SharpSharp

–MechanicalMechanical

–ChemicalChemical

–AutolyticAutolytic

DE-BUGDE-BUG

BIOFILMS

Biofilms are present in 60% of chronic wound biopsies

Only 6% of Acute Wound Biopsies

Biofilms retard wound healing

Schierle WWR 17:2009

BIOFILMSBiofilms 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

DECIDE: DECIDE: WHAT DRESSINGWHAT DRESSING

Wound care dressing orders for 202 patients Wound care dressing orders for 202 patients receiving home health or HMO carereceiving home health or HMO care

42% Wet-to-Dry42% Wet-to-Dry

7.5% Enzymatic7.5% Enzymatic

7% Dry Gauze7% Dry Gauze

Cowan L, Stechmiller J. Cowan L, Stechmiller J. Advances in Skin and Wound CareAdvances in Skin and Wound Care Dec, 2009Dec, 2009

DECIDE: DECIDE: WHAT DRESSINGWHAT DRESSING

TO DRY:•Alginates•Foams•ABD’s•Polymers•NPWT

TO MOISTEN:•Hydrogel

•Medihoney

•Ointments

DECIDE: DECIDE: WHAT DRESSINGWHAT DRESSING

ANTIMICROBIAL

Silver

Iodosorb

Medihoney

ACTIVE DRESSING

Collagens

Regranex

Skin Substitutes

DE-LOADDE-LOAD(Off- Load)(Off- Load)

OFF LOADING DEVICES

OFF LOADINGTOTAL 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

BENCHMARKING

Off Loading is the #1 Benchmark

Diabetic Control

Vascular Exam

A 50% reduction in wound area at 4 weeks

is a surrogate marker predictive of wound healing.

% Area Reduction at 4 weeks

Percentage of Area Reduction =

(A1 - A2) ÷ A1 x 100

A = Length x Width

FAILURE TO ACHIEVE 50% CLOSURE

@ 4 WEEKS REQUIRES ADVANCED

THERAPIES

FAILURE ADVANCED TXFAILURE ADVANCED TX

Negative Pressure

Wound Therapy

FAILURE ADVANCED TXFAILURE ADVANCED TX

Living Skin Substsitutes

Living Skin Substitutes

FAILURE ADVANCED TXFAILURE ADVANCED TX

Hyperbaric Oxygen Therapy

Deformity can be Deformity can be mitigated with mitigated with appropriate appropriate footwear.footwear.

Severe deformity Severe deformity may be corrected may be corrected with surgerywith surgery

FAILURE ADVANCED TXFAILURE ADVANCED TX

MOVING FORWARD

LEAVING EXPERT OPINION BEHIND

GOING TO EVIDENCE BASED RECOMMENDATIONS TO DEVELOP PROTOCOLS

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