Healthy

Feet & Lower Legs

R. Gary Sibbald, MD, M.Ed, D.Sc (Hons), FRCPC (Med, Derm), FAAD, JM

Professor of Public Health & Medicine

University of Toronto

Director of International Interprofessional Wound Care Course & Masters of Science - Public Health (Prevention & Wound Care)

Clinical editor Advances in Skin & Wound Care

1

Dr. Sibbald’s Potential Conflicts of Interest:Unrestricted educational grant from Valeant Pharmaceuticals

to develop the Healthy foot ScreenClinical Editor- Advances in Skin & Wound Care

Company/ Agency Paid Lecturers

Advisory Board Members

ResearchParticipants

Systagenix/ Acelity √ √ √

Mölnlycke √ √ √

RNAO- Registered Nurses Association of Ontario

√ √

Galderma √

Leo √

Hollister √ √ √

Health Point/ Smith & Nephew √ √

Valeant √ √ √

Abbott/ Abbvie √ √ √

MH-LHIN, MHLTC, HQO = Province of Ontario Government

√ √

Eli Lilly Canada Inc. √

Ferris Manufacturing Comp √

Objectives

Participants will:

Discuss the

Simplified 60 sec. screen for high risk diabetic foot

Promote foot health

Review the development and

validation of a quick efficient

foot screen for all patients

3

4

Focus on Prevention:

60 Second Screening

•History

•Inspection - abnormalities

•Palpate pulse

•Deformity

•Monofilament testing

(4 out 10 negative)

After Inlow 60 sec exam

Available at www.diabeticfootscreen.com

www.WoundPedia.com

• Any 1 positive result indicates high risk status

→ patient referred to diabetic foot centre for

follow up, education on foot care and foot

wear, and plantar pressure redistribution as

necessary

• Adopted by the Ministry of Health for use

throughout Guyana, South America

& around the world through the

IIWCC

Tool for High Risk Diabetic Foot: Validation & Clinical Pilot: Simplified 60 Second Diabetic Foot Screening ToolM. Gail Woodbury, R. Gary Sibbald , Brian Ostrow, Reneeka Persaud, Julia M. Lowe

Published: June 29, 2015-Open Access- Impact Factor 10.14

Major Amputations at Main Referral Hospital, Guyana

Risk Months Mean

St.

dev

95%

CI T test

Before

DFC 42 7.95 3.99 1.24 P <

0.0001After

DFC 42 4.14 2.36 0.73

48% reduction from pre-project levels

48 limbs saved each year =

192 limbs to July 2012

68% reduction in monthly proportion of DFU

despite 75% increase in DFU admissions

Lowe, Sibbald. Ostrow et al. PLOS Med April 2015Open Access IF= 10.14

PLoS Med. 2015 Apr; 12(4):

The Guyana Diabetes and Foot Care Project

Why is Foot Health Important?

75% of populations will experience foot pain

The foot contains 26 bones, 133 joints, 107 ligaments, and 19 muscles

The average wear and tear on a foot is equivalent to the distance a person covers in a lifetime, which is about 115,000 miles.

Physical ailments can first manifest in the foot:

diabetes

arthritis

peripheral vascular disease

cardiac disease

7

http:// www.wellnessmag.com/

article/feet-how-important-are-they

A foot out of alignment cam result in discomfort

and pain to the foot, ankle, knee, hip, and back (e.g. Reflexology)

Why

• 90% of patients are not people with diabetes – some are and not yet diagnosed!!

• Produce a simple and rapid-to-use clinical screening tool

• Detect common foot abnormalities, including onychomycosis

Study Design

• Develop, pilot, validate and produce a novel foot screening tool

• Methodology based on criteria for reliability testing of Donner and Eliasziw (1987)

& principles similar to those in Woodbury et al. (2015); a pilot

& validation study of a novel simplified 60-second foot screen

Development and validation of a

healthy foot screening tool8

• Donner, A. and Eliasziw, M. (1987), Sample size requirements for reliability studies. Statist. Med., 6: 441–448. doi:10.1002/sim.4780060404

• Woodbury MG, et al. Tool for Rapid & Easy Identification of High Risk Diabetic Foot: Validation &

Clinical Pilot of the Simplified 60 Second Diabetic Foot Screening Tool.

• Santanelli, di Pompeo d’Illasi F, ed. PLoS ONE. 2015;10(6):e0125578. doi:10.1371/journal.pone.0125578.

Elements of the Healthy Foot Screen

1. Known diabetes mellitus type 1 or 2 (perform simplified

diabetic 60-second screen)

2. Smoking status

3. Symptoms of neuropathy (perform simplified diabetic 60-

second screen)

4. History of previous foot ulcer or amputation

5. Signs of toenail fungal infection or inflammatory changes

6. Abnormal toe webs

7. Bottom of foot dry

8. Significant bony abnormality

9. Foot pulse palpable

10. Pitting edema of feet/ankles

9

Global Diabetes Tsunami10

IDF Atlas 5th edition diabetes

prevalence (age 20-79)

Guyana

South

America

15%

Year Persons with Diabetes Comment

2011 365 million • 4.6 million DM related deaths annually

• Spending on DM 465 million US

2030 552 million • 50% increase

• Additional 398 million at high risk

75% of people with diabetes now live in

low-and middle-income countries

4th leading cause of death

1. Known diabetes type 1 or 2

Higher Incidence of Gangrene + Foot Ulcers

in Patients with Diabetes and Onychomycosis

1% 2.2%0.6%

4.8%6.2%

1.2 %0

1

2

3

4

5

6

7

Gangrene Foot Ulcer Gangrene + Foot Ulcer

Incid

en

ce

(%

)

Without Onychomycosis With Onychomycosis

1.Doyle J, Boyko W, Ryu S, Gause E.. Diabetes. 2000;49(suppl 1): A195-A196.

Onychomycosis Increases Risk of

Developing the Diabetic Foot

International Diabetes Federation. Clinical Practice Recommendation on the Diabetic Foot:

A guide for health care professionals : International Diabetes Federation, 2017.

2. Smoking status

Smoking = Double indemnity

“Every cigarette will decrease the circulation in

the leg or foot up to 30% for an hour or

increase sympathetic” tone for 8 hours”*

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*Cigarette smoking decreases tissue oxygen. –

Jensen JA - Arch Surg - 01-SEP-1991; 126(9): 1131-4

3: Neuropathy

Contextualize Answer: Consider investigations/ patient counselling

Burning, stinging, shooting or

stabbing in either feet

Simplified 60 second screen should be performed in any

person with neuropathy

Symptoms of neuropathy- Consider:

• Diabetes

• B12 deficiency

• Trauma• Thyroid disease

• Toxins- Environmental, Chemotherapy

• Cancer- Growth impinge on nerves

• Kidney disease

Idiopathic

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Types of neuropathy:

Sensory- loss of protective sensation (LOPS)

Autonomic- dry plantar surface, not mocassin

Motor- absent or diminished reflexes

4. History of previous ulcer or amputation

1. Previous Ulceration 2. Previous Amputation

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Indicate a high-risk foot – requires intervention

5. Signs of toenail fungal infection or

inflammatory changes

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Distal and lateral

subungual

Proximal

subungualTotal dystrophic

onychomycosis

Dermatophytoma

Mild Moderate Severe

Photos AK Gupta

Superficial white

onychomycosis caused

by nondermatophtytic molds

Classification of onychomycosis

Inflammatory

changes:

E.g. due to trauma,

psoriasis,

lichen planus

Tinea Investigations

Scraping or nail clipping for KOH examination or

culture and sensitivity

Scraping from the edge of the lesion

Clipping should include the subungal debris

About 20% falsely negative

Reasonable to perform 3 cultures before classed as negative

Can order 1%-1.5% hydrocortisone powder in antifungal cream twice

daily while waiting for the results

(order 100 gms)

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Diagnosis of Onychomycosis confirmed by:

- 1 positive microscopic result for at least 1 toenail + clinical presentation

AND/OR

- Positive culture for fungus

Mycological Cure Rates (Pooled Data)18

55% 54%

70-80%

36%

0%

10%

20%

30%

40%

50%

60%

70%

80%

Week 48

Pro

po

rtio

n o

f Su

bje

cts

Efinaconazole

Itraconazole

Terbinafine

CiclopiroxEF INECO

NAZOLE

CICLOPIRO

X

ITRACONAZO

LE

Sporanox (itraconazole) [package insert]. Janssen Pharmaceuticals Inc, Titusville, NJ; 2012.

Lamisil (terbinafine HCl) [package insert]. Novartis Pharmaceuticals Corporation, East Hanover, NJ; 2012.

Drake LA et al J Am Acad Dermatol 1997;37:740-5

Westerberg DP, et al. Am Fam Physician. 2013;88(11),

TE

R

B

I

N

A

F

I

N

E

Topical Oral Oral Topical

Pathway to the Prevention

and Treatment of Toe Onychomycosis

Detail: III Treatment strategies

1. Elewski B, et al. J Am Acad Dermatol 2013;68(4):600-8

2. Gupta AK, et al. J Drugs Dermatol. 2014 Topical efinaconazole = Jublia, Valeant

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6. Abnormal toe web spaces

4th – 5th toe web

space is most

common site for moisture retention resulting

in skin breakdown; all toe

webs should be checked

If dry, scaly: think fungus

If wet, macerated: think secondary bacterial

infection

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© Sibbald 2012

7. Dry foot

Important to diagnose cause

of dryness

Dryness of foot in a

Moccasin distribution: dryness

extends to sole, heel and sides of

foot - think fungus

Dryness on plantar surface of foot

alone – think neuropathy

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22

Hammer Toe –

proximal interphalangeal

joint down

Hallux valgus (Bunion)Claw Toe-

metatarsal phalangeal joint up

and interphalangeal joint down

8. Bony abnormalities + associated changes

(pressure, shear/friction)

• Flat foot: loss of plantar arch

• Callus: hyperkeratosis over a pressure point

• Blister: over area of friction or shear

9. Palpable foot pulse

Dorsalis Pedis

or

Posterior Tibialis

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Check the posterior tibial

if dorsalis pedis is negative

http://www.gla.ac.uk/ibls/US/fab/tutorial/generic/sapulse.html

Vascular Supply & Healing Ability

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Palpable Pulse ** >80 mm Hg

Ankle-brachial

pressure index

(ABPI)

>0.5 and <1.3

Audible Hand

Held Doppler

Alavi, Sibbald et.al 2015

Biphasic,

Triphasic

AHHD ABPI > 0.9

Toe pressure >55 mm Hg

Dilated saphenous vein

Superficial varicosities and varicose veins

Lower leg edema

Pigmentary changes of distal leg

Woody fibrosis

Lipodermatosclerosis

Progression of Venous Disease

10. Pitting edema of the foot or ankle?25

Other lesions: Red areas/ blisters or pustules

on the foot

Types of lesions Examples of common abnormalities

Red areas/ blisters or

pustules on the foot

Any change that the

evaluator is unsure of the

diagnosis should trigger

a biopsy referral or

therapeutic trial

Inflammatory

conditions

Infections

Benign Lesions

Pre-malignant /Malignancy

Psoriasis

Dermatitis

Lichen PlanusGouty Tophus

Plantar Fasciitis

Cellulitis

Plantar Warts

Corn or clavus

Morton’s Neuroma

Benign Stucco keratosis (SK)

Actinic keratosis (AK)Cutaneous horn

Basal Cell Carcinoma

Squamous Cell Carcinoma

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• Protocol development and ethics submission

• Preliminary draft of healthy foot screen developed

• Planning committee meeting with interdisciplinary wound care experts & sponsor

• Working draft of healthy foot screen developed

Validation day – 18 patients screened by 11 assessors

Fungal scrapings & bacterial swabs

Feedback from assessors & round table discussion – revised version of screen

• Statistical analysis - reliability scores

• Items with < 0.6 reliability score removed from screen

• Final draft of healthy foot screen produced for piloting

• Piloting of healthy foot screen on 120 patients over 2 months

• Final working version of the healthy foot screen will be produced

Development and validation of a healthy foot screening tool

27

Data analysis

28Data entered in SPSS Cronbach’s alpha calculated

Elements with < 0.6 reliability score were removed from screen (highlighted)

Healthy foot screening tool

29

Conclusion

A healthy foot screening tool will enable clinicians, especially primary care providers, to identify common foot problems (onychomycosis, infection/ inflammatory lesions, bony abnormalities, vascular insufficiency, etc.)

Early diagnosis and treatment can prevent amputations & result in improved patient quality of life & optimize resource allocation

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My grandchildren

Sophie Grace’s first dress-

6 weeks old

A good big brother

Sophie Grace and Luke Gary

Parking lot 32

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Onychomycosis Is a Common Nail Disease

34

12

6.5

0

10

20

30

40

EstimatedOnychomycosis

Population

Office Visits Diagnosed Patients

Millio

ns

Source: Scott-Levin PDDA. MAT October 2002.

Photograph: collection of A Gupta

Differential Diagnosis of Onychomycosis

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• Disease at other sites

• Nail ridging

• Splitting or thinning

• Loss of nails• Proximal pterygium

Lichen Planus

Eisman et al. BMJ. 2014;348:g1800.

Trauma Image: Alex Lozupone

Afifi et al. Can Fam Physician. 2005 Apr;51:519-25.

American Academy of Dermatology National Library of Dermatologic Teaching Slides.

Psoriasis

• Subungual hyperkeratosis

• Oil drop sign

• Splinter hemorrhages

• Nail pitting

• Psoriatic plaques

• Leuconychia

Trauma

• Abnormal nail

plate shape

• Distal onycholysis

• Often single nail

affected

• Uniform colour

change

Objectives

Participants have:

Discussed the Simplified 60 sec.

screen for high risk diabetic foot

Examined promotion of foot health

Reviewed the development and

validation of a quick efficient foot

screen for all patients

Explored clinical opportunities to

implement foot screening

35

Other lesions: Red areas/ blisters or pustules

on the foot

Types of lesions Examples of common abnormalities

Red areas/ blisters or

pustules on the foot

Any change that the

evaluator is unsure of the

diagnosis should trigger

a biopsy referral or

therapeutic trial

Inflammatory

conditions

Infections

Benign Lesions

Pre-malignant /Malignancy

Psoriasis

Dermatitis

Lichen PlanusGouty Tophus

Plantar Fasciitis

Cellulitis

Plantar Warts

Corn or clavus

Morton’s Neuroma

Benign Stucco keratosis (SK)

Actinic keratosis (AK)Cutaneous horn

Basal Cell Carcinoma

Squamous Cell Carcinoma

36