offloading workshop 2015 brock liden d.p.m.. better understand the effects of diabetes on the...

OFFLOADING WORKSHOP2015

Brock Liden D.P.M.

• Better Understand the Effects of Diabetes on the tissues of the foot.

• Identify New Quality Measures in Wound Care

• Better Understand the use of Contact Casting

Today’s Objectives

45 yo male patient

• Ulcer on the bottom of his left foot has been present for 4 weeks

• He says he walked through a mud puddle this spring, once his shoes dried, they shrunk and now his shoes are tight and rub.

Diabetes

•135 million Diabetics worldwide•United States 20.8 million Diabetics (7% of population)•1.5 million new cases yearly•25% diabetics develop foot ulcer during their lifetime•50% or more of amputations occur in diabetics

Brem H , et al; Protocol for treatment of Diabetic Foot ulcers Am J Surg 2004 187 S pp 1-10

Diabetes

• 82,000 amputations yearly• 7.7 to 16 per thousand• 15 to 40 times higher than non-

diabetics• 50% will have another amputation

within 5 years• Mortality Rate

– 1 year 13% - 40%– 3 year 35% - 65%– 5 year 39% - 80%

Brem H , et al; Protocol for treatment of Diabetic Foot ulcers Am J Surg 2004 187 S pp 1-10

Diabetes Fact:

85% of all diabetes-related lower extremity amputations are preceded by a diabetic foot

ulceration.

Death Rates by Disease

The likelihood of a diabetic being dead 5 years after an amputation is nearly 50%. This is more than double the chance of death from prostate or breast cancer.

Indications for Hospitalization

• Systemic signs : – fever, chills, leukocytosis, confusion, metabolic

disturbances (ketoacidosis, hyperglycemia)• Deep Space infection or abscess• Gas in soft tissues• Ascending cellulitis or lymphangitis• Osteomyelitis• Non-palpable pedal pulses

Indications for Hospitalization

• Presence of gangrene• Need for surgical intervention• Failure to improve in 48 hr-72 hr with oral antibiotics• Patient non-compliance• Presence of pathogens not susceptible to oral agents

Diabetes and Component Causes of Ulceration

• Loss of Protective Sensation– Sensori-Motor Neuropathy– Autonomic Neuropathy

• Peripheral Vascular disease• Glycosylation of connective tissues• Equinus deformity• Intrinsic Foot deformity/Muscle atrophy• Callus Formation• Previous Ulcer

Singh N, Armstrong D, Lipsky B, Preventing Foot ulcers in patients with Diabetes. JAM 2005 293:217-228.

BoultonAJ, KirsnerRS, Vileikyte L Clinical Practice neuorpathic diabetic foot ulcers N Eng L Med 2004;351(1) 48-55

Diabetes

• Effects of Diabetes leading to ulceration:– Loss of protective sensation Peripheral Neuropathy

• Present in 50% diabetics over age 60• Present in 80% of diabetics with foot ulcer• 7 fold increase in ulceration

– Sensory Motor Neuropathy• Single most common cause• Small fiber – Pain , Touch, Temperature• Large fiber – intrinsic foot changes, weakness, claw toe,

metatarsal head, fat pad changes, High foot pressure


Diabetes

• Autonomic Neuropathy– Leads to skin changes dry, cracked, atrophic and

increased callus formation– Impairs micro circulation by shunting, impairs

vasodilation and normal hyperemic response, – Increases edema– Increased capillary pressure and microvascular sclerosis

• Leads to tissue ischemia and lessens protective barrier to injury


Neuropathy

• Diabetic peripheral neuropathy: – severe pain– electrical – sharp shooting pain– burning pain– tingling pain.

• Treatment:– Neurontin (gabapentin) – Cymbalta (duloxetine hydrocholride)– Lyrica (pregabalin)

Diabetes Affects Mobility and Pressure

• Glycosylation results in thickening and crosslinking of collagen

• Limits joint mobility and loss of flexibility resulting in fixed contracture and higher foot pressures

• Callus formation and ulceration in presence of neuropathy


• Foot deformity results in increased pressure and biomechanical alteration

• Pressure highest in the forefoot• Equinus Deformity assoc with risk of

higher plantar pressures (3X)

Diabetes Affects Mobility and Pressure

DuckworthT, Boulton A, Betts R, et al; Plantar pressure measurements and the prevention of ulceration in the diabetic foot. J Bone Joint Surg 67b 1985 p79-85Cavanagh P, Simoneau G, et al; Ulceration unsteadiness and uncertainty the biomechanical consequences of diabetes mellitus. J Biomech 26(1) 1993 p23-40Lavery L, Armstrong D, Boulton A, Ankle equinus deformity and its relationshi[ to high plantar pressure in a large population with diabetes mellitus JAPMA 92(9) 2002

Achilles Tendon Lengthening

• TCC 29 / 33 (88%) ulcers in healed (41=/- 28 days)• Achilles Lengthening 30/30 ulcers (100%) healed (58+/- 47

days) (p >0.050)• Recurrence of ulcer a 7 months (p = 0.001)

– 16/27 (59%) in the total-contact cast group– 4/27 (15%) in the Achilles tendon lengthening group

• 2 year follow-up Ulcer recurrence– 21/26 (81%) total-contact cast group– 10/26 (38%) Achilles tendon (p = 0.002)

Mueller MJ, Sinacore DR, et al Effect of Achilles tendon lengthening on neuropathic plantar ulcers. A randomized clinical trial J Bone Joint Surg 2003 85 A(8) P 1436-45

• Achilles tendon lengthening should be considered an effective strategy to reduce recurrence of neuropathic ulceration of the plantar aspect of the forefoot in patients with diabetes mellitus and limited ankle dorsiflexion (</=5 degrees ). Click icon

to add clip art

Achilles Tendon Lengthening

Mueller MJ, Sinacore DR, et al Effect of Achilles tendon lengthening on neuropathic plantar ulcers. A randomized clinical trial J Bone Joint Surg 2003 85 A(8) P 1436-45

Guidelines and Quality Measures

Quality Measures In Wound Care

• U.S. Wound Registry (http://www.uswoundregistry.com/Specifications.aspx)

• Eligible Professionals (EPs) can earn 2014 PQRS incentives by meeting the following requirements:– Report on a minimum of 9 measures covering 3 National Quality

Strategy (NQS) domains for at least 50 percent of the EP's applicable patients seen during the 2014 participation period

– At least 1 of the 9 measures submitted must be an outcome measure (containing denominator data fulfilling both exceptions and exclusions, as well as numerator data)

– 12 Wound Specific Measures to report 4 specific Diabetic Wound Measures Offloading is # 1 DFU001

– 31 PQRS Related Measures

(http://www.uswoundregistry.com/Specifications.aspx)

12 Wound Specific Quality Measures4 DFU Quality Measures

Measure Number Title of Measure

DFU 001Process Measure : Adequate Offloading of DFU at Each Visit

DFU 002 Outcome Measure: DFU healing or Closure

DFU 003Process Measure: Plan of Care for DFU not Achieving 30% Closure at 4 weeks

DFU 004 Comprehensive Diabetic Foot and Ankle Exam

Offloading Quality Measure DFU001

• Total Contact Casting is the Gold Standard• Casting contraindicated when Moderate to Severe

ischemia present • Crow Walker or removable device is an alternative• Crutches• Wheelchair

Off-loading is widely considered the single most important intervention necessary to accomplish wound healing in the management of the diabetic foot ulcer.


Quality Measures

• PQRS Measure #126 Diabetes Mellitus: Diabetic Foot and Ankle Care, Peripheral Neuropathy - Neurological Evaluation

• PQRS Measure #127 Diabetes Mellitus: Diabetic Foot and Ankle Care, Ulcer Prevention – Evaluation of Footwear

• PQRS Measure #163 Diabetes: Foot Exam


Organized Approach to Wound Care

1. Is there adequate perfusion and/or oxygenation?

2. Is non-viable tissue present?3. Are signs/symptoms of infection

and/or inflammation present?4. Is offloading or pressure relief

appropriate?5. Is edema controlled?6. Is tissue growth optimized?7. Is the wound microenvironment

conducive to healing?8. Is pain controlled?9. Are host factors optimized?

Offloading

Disease Process Controlled

BioBurden

Advanced Modalities

Wound Moisture Balance

Debridement

Blood Flow

Patient Centered Pain

Edema

Why is it so hard to do the right thing in wound care?

Fife CE, et al; “Why is it so hard to do the right thing in wound care” Wound Rep Reg : 18 p 154-158 2010

• 6% DFU patients had “Gold Standard” TCC used• Cost of care was half that of those that did not• TCC is time consuming and poorly reimbursed• 17% VLU patients received adequate compression• Inadequate reimbursement• Lack of familiarity with Clinical practice Guidelines

With Permission John Wiley & Sons Ltd.

TCC Cost Effectiveness

• Cost of care when TCC was utilized was HALF1!

–$11,946 vs. $22,494

• Why is it so hard to do the right thing in Wound Care?

$-

$5,000

$10,000

$15,000

$20,000

$25,000

With TCC Without TCC

Cost of DFU Treatment1

1. Fife C, Carter M, Walker D. Why is it so hard to do the right thing in wound care?. Wound Repair & Regeneration [serial online]. March 2010;18(2):154-158.

• 3 Factors Affect compliance with Evidence Based Wound Practice– Complexity– Cognitive Effort– Compensation System

Why is it so hard to do the right thing in wound care?

Fife CE, et al; “Why is it so hard to do the right thing in wound care” Wound Rep Reg : 18 p 154-158 2010

Wagner Classification

• Grade 0 Callus without Ulcer• Grade 1 Superficial Ulcer without apparent infection• Grade 2 Deep Ulcer commonly with Cellulitis• Grade 3 Deep Ulcer with Abscess, Cellulitis, and/or Osteomyelitis• Grade 4 Partial Gangrene• Grade 5 Gangrene of the entire Foot

Contemporary Diagnosis and Management of Diabetic Foot Infections 2006 pp. 128

Comprehensive Foot and Ankle Exam

• General Inspection: Including evaluation of proper footwear

• Dermatologic: Including skin status, sweating, infection, ulceration, calluses, blistering

• Musculoskeletal: Including deformity and muscle wasting• Neurological Assessment: Including 10 g monofilament of

one of the four following: vibration using 128 Hz tuning fork, pinprick sensation, ankle reflexes or VPT o Vascular

• Assessment: foot pulses and ABI if indicated


PQRS Measure #127 Diabetes Mellitus: Diabetic Foot and Ankle Care, Ulcer Prevention – Evaluation of Footwear

Required to examine their shoes

Shoes and your patient

Diabetes

• Peripheral Vascular disease– More common in diabetics (twice)– Higher incident of infra popliteal disease and

bilateral disease– Multi segment involvement

• Tibial, Peroneal, Small vessels

– Pedal vessels spared• Autonomic neuropathy causes shunting and

microcirculatory malfunctionSingh N, Armstrong D, Lipsky B, Preventing Foot ulcers in patients with Diabetes. JAM 2005 293:217-228.

Levin ME: Pathogenesis and general management of foot lesions in the diabetic patient. Levin and O'Neal's The Diabetic Foot. Bowker JH, Pfeifer MA (eds). St. Louis, CV Mosby, 6th Ed, 2001, pp 219-260

Vascular evaluation

Ankle Brachial Index : ABI

• ABI : Systolic Ankle pressure divided by the Systolic Brachial pressure

• < 0.9 suggests atherosclerotic vascular disease with 95% sensitivity and 99% specificity

• Falsely elevated when arteries heavily calcified as is seen in diabetes

Baumgartner I, Schainfeld R, Graziani L. Management of peripheral vascular disease. Annu Rev Med. 2005;56:249-72

Endovascular Intervention

• Balloon dilatation and stenting

• Laser arthrectomy and stenting

• Cutting devices and stenting

Debridement

• Removes de-vitalized tissue• Enables to measure the true wound

dimensions• Reduces risk for infection• Enables Deep culture of viable tissue• Removes non-migratory cells from

the ulcer edge (epibole). • Develops a proliferative migratory

wound edge.

1 2 3 4 5 6 7 80

5

10

15

20

25

30

35

DFU

Debridement every visit

No debridement

Serial Debridement and Wound Healing

Debridement and DFU

Cardinal M, Eisenbud DE, Armstrong DG, Driver V, Attinger C, Phillips T, Harding K; Serial surgical debridement: A retrospective study on clinical outcomes in chronic lower extremity wounds. Wound Repair Regen 17(3) pages 306–311,2009

•Centers where patients were debrided more frequently were associated with higher rates of wound closure (DFU p=0.015)

•“Our results suggest that frequent debridement of DFUs may increase wound healing rates and rates of closure”

Microbiology of Diabetic Foot Infections

• Average number of isolates 2.8

• Range 1-5 • 49.7 % aerobes• 41.6 % aerobes and

anaerobes• 3 % anaerobes• Diabetic Foot infections are

polymicrobial

Probe to Bone Test

• 247 patients with DFU• 151 patients developed infection• 30 developed osteo

– 12% of those with DFU– 20% of those with infection

• Positive predictive value .57• Negative predictive value .98• May not prove osteo present but good

chance its not when negative

Lawrence A. Lavery, David G. Armstrong, Edgar J.G. Peters and Benjamin A. Lipsky. Probe-to-Bone Test for Diagnosing Diabetic Foot Osteomyelitis . Reliable or relic? Diabetes Care 30: 270-274, 2007

Foot Inspection

• Patient self foot exam important in surveillance

• Identifies areas of callus and injury

• Early identification of wound lessens the likelihood of amputation

Boulton AJ, Lowering the risk of neuropathy, foot ulcers and amputations. Diabetes Med 1998;15 suppl 4 :S57-9Kumar S, et al, Semmes-Weinstein monofilaments: a simple, effective and inexpensive screeningdevice for identifying diabetic patients at risk of foot ulceration. Diab Res Clin Pract 1991 Aug 13(1-2):63-7

Evaluate Sensory Loss

• 5.07 Semmes-Weinstein (10-g) nylon filament test

• Vibratory sensation• Loss of sensation predicts

risk for development of ulcers

• Education with screening and orthotic foot wear can lower risk of amputation

Boulton AJ, Lowering the risk of neuropathy, foot ulcers and amputations. Diabetes Med 1998;15 suppl 4 :S57-9Kumar S, et al, Semmes-Weinstein monofilaments: a simple, effective and inexpensive screeningdevice for identifying diabetic patients at risk of foot ulceration. Diab Res Clin Pract 1991 Aug 13(1-2):63-7

TCC SystemsRoll on Fiberglass

ModelsSlip on Sleeve

Model

Results of 9 TCC Studies

• Average Healing Time: 43.73 days• Percent Healed:

88.9%Helm 1984; Sinacore 1987; Walker 1987; Mueller 1989; Meyerson 1992; Birke 1992; Lavery 1997; Armstrong 2001; Birke 2002

• Patient must be non-infected.• Adequate blood supply to heal ABI ≥0.8• Wagner classifications – Grade 1 and 2 go can go into TCC’s and be managed effectively on an out-patient basis. •Good complement to HBO• Wounds that probe to tendon, capsule or bone, or with abscesses do not go into TCC’s!

Total Contact Cast: Indications

TCC Patient Selection

Plantar Diabetic & Neuropathic Foot Ulcerations – Wagner Grade 1-2

–Diminishes the vertical & shearing forces of walking, allowing a plantar/lateral lesion to heal

Non-Infected with Reasonable Vascular Status

Charcot Neuroarthropathy Fractures–Eliminates the stresses of weight bearing, allowing the condition to consolidate

Post-operative management–To immobilize the surgical site to allow healing by minimizing the weight-bearing & shear forces

Total Contact Cast Contraindications

• Acute Infection• Severe Ischemia• Claustrophobia• Wagner Grade 3,4• Non-Compliance• Allergy to casting material• Excessive or fluctuating

edema• Excessive drainage

TCC Functional Attributes

•Allows for healing while ambulating•Forced Compliance• Immobilization, “total contact” with forefoot, arch, heel, Achilles tendon, and cone of lower leg. No “pistoning”•Ankle locked at 90%.

•Eliminates the propulsive phase of gait•Shortens stride length

•Minimizes vertical (Ground Reactive Pressures) and shear stresses•Protects affected limb from trauma

Total Contact Cast

“The device has been shown to decrease plantar pressures to nearly imperceptible levels of 0.34 n/cm2. The near complete

elimination of motion in the TCC also substantially curtails shearing forces.”

- Todd, WF; Ostomy & Wound Management,

August, 1995

How does the cast offload?

• Cast offloads by transferring weight bearing to the leg itself

• Total contact weight bearing on plantar surface

Off-Loading the Diabetic Foot Wound Armstrong, et al Diabetes Care, June 2001

89.5%

65.0%58.3%

33.5

50.4

61.0

0

10

20

30

40

50

60

70

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Total Contact Cast Removable Cast Walker

Half Shoe

Percent Healed

Mean Days to Healing

Cost Impact for Physicians and Clinics

• CPT 29445 : Application of rigid total contact leg cast•Reimbursement National Ave $110.00• CPT 29445 Clinic Code links to APC 0426 •National Ave Reimbursement $148.00

Healing/Days to HealTCC vs iTCC vs RCW

51.9

82.689.5

58

33

41.6

0

10

20

30

40

50

60

70

80

90

100

TCC iTCC RCW

Healing Rate

Days to Heal

Armstrong DG, Lavery LA, Wu S, Boulton AJ. Evaluation of removable and irremovable cast walkers in the healing of diabetic foot wounds: a randomized controlled trial. Diabetes Care. 2005;28(3):551–554.

Casting and Dressings

• Vaseline gauze has been the standard• Other materials may be effective and

beneficial• Materials can deliver actives to the wound

over time• New customizable dressings may allow

specific timing and delivery

Legal Issues in Diabetic foot care

• Most Common Omissions Leading to Litigation• Failure to educate the patient about proper foot care• Failure to perform a neurologic or vascular examination• Failure to control blood glucose level• Failure to adequately debride ulcer• Failure to culture the wound for aerobes and anaerobes• Failure to x-ray• Failure to recognize worsening infection• Failure to inform patient of the signs and symptoms of worsening infection• Failure to prescribe non-weight bearing• Failure to hospitalize or delayed hospitalization in the face of worsening infection• Failure to obtain consultation or delay in doing so

Click icon to add clip art

Frank JJ, Frank JA: Medicolegal aspects of care and treatment of the diabetic foot. Levin and O'Neal's The Diabetic Foot. Bowker JH, Pfeifer MA (eds). St. Louis, CV Mosby, 6th Ed, 2001, pp 757-765

13 Most Common Causes of Litigation in Diabetic Foot Cases

• Failure to Educate patient about proper foot care

• Failure to control blood sugar• Failure to culture wound• Failure to prescribe non-weight bearing• Failure to adequately debride ulcer



• Failure to perform Vascular exam• Failure to recognize worsening infection• Failure to X ray• Failure or delay in consultation



• Failure to hospitalize or delay to hospitalize in face of worsening infection

• Failure to inform the patient of the signs of worsening infection

• Failure to properly document the case• Failure to disclose all risks involved and obtain

informed consent


Diabetic Education

• Diabetic Education– Three fold increase in

Amputation rate without education

– Inspect feet daily or family member (poor vision)

– Foot ware appropriate– Glycemic Control– Smoking cessation

Thanks for your attention

offloading workshop 2015 brock liden d.p.m.. better understand the effects of diabetes on the...

Documents

diabetes effects of

diabetic foot ulceration

left foot

diabetes autonomic neuropathy

diabetes fact

non diabetics

high foot pressure singh

diabetics brem h