Compression Consultations for the

Diabetic Patient

Kimberly Simmons, PharmD, MBAUS Pharmacy Relations Manager

SIGVARIS, Inc.

Adjunct Associate Professor of Pharmacy PracticeMercer University College of Pharmacy and Health Sciences

University of Georgia College of Pharmacy

Program Sponsored by SIGVARIS

Global leader in graduated compression garments for prevention and management

of venous insufficiency/disease

This is commercial program; no CE credits will be This is commercial program; no CE credits will be offered!offered!

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The SIGVARIS Difference…

Double Covered Yarns• Increased durability• Omission of ‘shininess’• Provides for anatomically correct fit• Enhances patient level of comfort

in donning and doffing• Improved patient compliance

Covered spandex

2nd covering(S-twist)

1st covering(Z-twist)

The SIGVARIS Difference…

SIGVARIS offers flexible ready-to-wear sizing options to fit 98.2% 98.2% of the population

while ensuring maximum comfort

and increasing compliance

The SIGVARIS Difference……we work for you & with you to so you can

generate alternative revenue!

Pharmacist managed pharmacy relations department for business support

Healthy leg days Physician detailing Online dealer

locator Distributed dealer

list

Provide complimentary customized & generic marketing materials

Quarterly business reviews

Training & education programs

Do you currently carry and/or consult patients on graduated compression socks or stockings for your patients?

Objectives• Discuss the epidemiology of lower

extremity complications in the diabetic patient

• Discuss graduated compression therapy and it’s uses

• Explain the etiology of lower extremity edema in the diabetic patient

• Describe lower extremity edema management with graduated compression therapy

• Discuss compression consultation points for diabetic patients

Diabetic Patient use of Pharmacy Services

Georgetown University. Center on an Aging Society. Sept. 2002 (5). 1-6. Available at: http://hpi.georgetown.edu/agingsociety/pdfs/rxdrugs.pdf. Accessed 05/03/12.

25.825.8

1 American Diabetes Association. Data from the 2011 National Diabetes Fact Sheet (released Jan. 26, 2011). Available at: http://www.diabetes.org/diabetes-basics/diabetes-statistics/. Accessed 05/03/12

$174 BILLION

1 American Diabetes Association. Data from the 2011 National Diabetes Fact Sheet (released Jan. 26, 2011). Available at: http://www.diabetes.org/diabetes-basics/diabetes-statistics/. Accessed 05/03/12

The old saying “An ounce of prevention is worth a pound of cure” was never as true as it is when preventing amputations!

Factors Leading to Lower Extremity Amputations

• Peripheral neuropathy• Infection

▫Antibodies respond slower to infections secondary to the poor circulation

• Deformity of the feet▫Diabetes can affect the

joints making them stiffer• Vascular disease

▫Poor circulation can affect the body’s ability to heal when damage occurs

Vascular Disease: Arterial & Venous Disease

Venous Disease (PVD)Inadequate return of venous blood from the legs to the heartClinical Symptoms: tired/heavy, achy cramping in the legs; pain worsens when standing and improves with leg elevation and activity

Arterial Disease (PAD)Narrowing of the arteries, commonly the pelvis & legsClinical Symptoms: cramping, pain, tired legs or hip muscles that worsens during walking/activity and subsides with rest

PAD=peripheral arterial disease; PVD=peripheral venous disease

Epidemiology of Vascular Disease

PAD= Peripheral arterial diseaseNational Heart Lung and Blood Institute (NHLBI). Available at: http://www.nhlbi.nih.gov/ Accessed 01/27/11.Society of Interventional Radiology (SIR) Website. 2003. Available at: http://www.scvir.org/patients/varicose-veins/. Accessed 05/28/2009/Vascular Disease Foundation Newsletter. Spring 2005; Volume 5, N2

60% of American suffer from vascular disease and its sequelae More people lose time from work and are

affected by venous disease than from arterial disease

50% of Americans are affected by vein disease

Diabetic patients have a 2-5 times greater risk for developing PAD vs. non-diabetic patients Approx. 1 in 3 diabetic patients >50 years

has concomitant PAD

Veins

60-70%

Arteries

10-12%

102030405060708090

100

0

The venous system contains most of the blood as it moves

through the circulatory system.

Most of the

blood

Perc

en

t D

istr

ibu

tion

Lungs

10-12%

Heart

8-11%

Capillaries

4-5%

Hole’s Human Anatomy and Physiology, 7th Edition, 1996

Audience Response

What etiologic factors directly contribute to the development and progression of venous disease?

A.Incompetent valvesB.High blood pressureC.Improper venous returnD.A and BE.All of the above

Physiology of the Normal Venous Circulation: Competent Valves

Valve Open Pumps blood against gravity towards heart

Valve Closed Inhibits gravitational reflux of

pumped blood

Physiology of the Normal Venous Circulation: Incompetent Valves

Vein Wall InjuryVein Wall Injury

↑↑

Venous Venous HypertensionHypertension

↑↑

Damaged ValvesDamaged Valves

Sources of Venous Return

•Calf muscle (2nd heart)•External foot pump•Arterial pressure•Abdominal/intrathoracic

pressure

Examples of Vein Disease Complications

Telangiectasia(spider veins)

Varicose Veins

Deep Vein Thrombosis

Lipodermatosclerosis

Superficial Phlebitis

Examples of Vein Disease Complications

Leg EdemaVenous Hypertension

Chronic Venous Insufficiency

Venous Ulcers

• Lower extremity edema is a common clinical finding in diabetic patients▫ Graduated compression therapy is the standard

treatment for edema▫ Graduated compression therapy is a precaution in

diabetic patients because of concomitant arterial disease

• Lack of reliable measures to objectively quantify edema makes it difficult to assess it’s prevalence in diabetic patients

• Edema in diabetics is difficult to isolate and may have multiple etiologies▫ Edema may be attributable to anti-diabeties meds

such as: Actos, Avandia, ACTOplus met, Byetta

Lower Extremity Edema:A Complication of Poor Circulation

Brodovicz KG, et al. Clin Med Res. 2009;7(1-2):21-31.Fries R. MMW Fortschr Med. 2004;146(16):39-41.Powell AA, et al. Am Fam Physician. 1997;55(5):1721-6.

Safety and Efficacy of Mild Compression (18-25mmHg) Therapy in

Patients with Diabetes and Lower Extremity Edema

Wu SC, Crews RT, Najafi B, et al. J Diabetes Sci Technol 2012 Vol 6 Issue 3• 4-week pilot study

• N=18▫ Diabetes▫ Lower extremity edema of the leg, foot, and ankle▫ Ankle-brachial index (ABI) >0.6

• Assess whether diabetic compression socks* can reduce LE edema in diabetic patients without compromising vascularity

• Mild graduated compression socks (18-25mmHg) decreased swelling in diabetic patients with LE edema without compromising vascularity

LE=lower extremity

Defining Anti-embolisms (TEDs)“TEDS are for BEDS”“TEDS are for BEDS”

Anti-embolismsTherapeutic Compression Ranges: 18-8mmHg,

20-10mmHgUtilized in the hospital or nursing home setting For bed-ridden patients

Class A (8-15mmHg) compression reflects the standard in some countries but there is insufficient clinical evidence to support it’s use in practice. (European Prestandard, 2001)TEDS=Thromboembolic Deterrent Stockings

Anti-embolismsIndicated for prevention of

thromboembolisms in recumbent patientsrecumbent patients

Defining Graduated Compression Therapy“Stockings are for Walking”“Stockings are for Walking”

20 - 40%

50 - 80%

100%

Pictures obtained from http://www.newlook.com.sg/tedantiembolismstockings.asp. Accessed 09/02/10.

• Compression therapy is the application of controlled graduated external pressure to the limb to reduce venous pressure within the limb.

• Strongest at the ankle and decreasing in the proximal direction

• To be effective, must fit over the calf• Require measurement, fitting,

and patient counseling by a certified and trained compression specialist

Audience ResponseHow do you know what level of compression pressure is appropriate for the patient?

A.Physician prescriptionB.Patient requestC.Assessment of venous complicationsD.A and B onlyE.All of the above

Graduated Compression Indications

There is insufficient clinical evidence to support the clinical efficacy of compression pressures <15mmHg to support ambulatory patients. (European Prestandard, 2001)

Shoe Size Precisely Measured

15-20mmHg 18-25mmHg 20-30mmHg 30-40mmHg 40+mmHg

• Tired, achy legs• Occupational or

evening edema• Leg discomfort

from prolonged standing/sitting

• Preventing pregnancy varicosities &swelling

• Predisposed risk• Reduce travel

swelling• Prevention of

traveler’s thrombosis

• Lower extremity edema in diabetic patients without contraindications and ABI >0.6

• Heavy, fatigued, aching legs

• Mild edema in lower extremities

• Mild varicosities w/ minimal edema

• Mild varicosities & pregnancy edema

• Post-procedure of small veins

• DVT prevention or management

• Moderate varicosities w/ mild-moderate edema ± pregnancy

• Post-procedure of larger veins

• CEAP C3, C4, C5, C6

• Recurrent or active venous ulceration

• DVT prevention or management

• DVT or PTS treatment

• Severe varicosities

• Severe edema• CEAP C4, C5,

C6• Recurrent

venous ulceration

• Severe post traumatic, fracture edema

• Severe PTS

A simple change of socks!!!A simple change of socks!!!

Why are graduated compression garments sized and measured to precisely fit patients?

Graduated compression therapy is “Medicine you

Wear”

What compression consultation would you offer this

diabetic patient presenting to your pharmacy?

“Your labs show you have diabetes. I know your legs hurt

but you need to exercise to improve your circulation, and start Actoplus met!”

Selecting the ‘Right’ Diabetic Compression Sock • Promotes circulation• Fiber blend of cotton, acrylic, nylon, and elastic

▫Regular 100% wool or cotton socks are too tight on the foot, reduce circulation, and are not cool and do not keep the foot dry

• Cushioned▫Regular socks do not provide comfort and protection

• Flat seams▫Coarse seams on regular socks rub the foot and .

cause blisters and calluses to emerge

Feldman CB, et al. Diabetes Spectrum.14(2), 59-613Herring KM, et al. J Amer Pod Med Assn. 80, 63-70.

Diabetic Compression Sock Target Patient Population

•Pre-diabetic•Newly diagnosed•Edema•Gestational diabetes•No neuropathy•ABI >0.6 without

claudication

Diabetic patients a more likely to exercise when their legs feel good!

Key Benefits: •Clinically proven to reduce swelling and improve circulation•American Podiatric Medical Association (APMA) Seal of Approval•Non-binding calf band•Flat toe seam•Extra padding on foot•DriRelease fiber blend for moisture wicking, odor control, and softness•Latex free•True graduated compression

Compression Level: 18-25mmHgStyle(s): Over the Calf Color(s): White Retail Price: $30-40

Diabetic Compression Sock

Diabetic-friendly Compression Sock

Key Benefits: •Diabetic-friendly •Non-binding calf band•Flat toe seam•Extra padding on foot•DriRelease fiber blend for moisture wicking, odor control, and softness•Latex free•True graduated compression

Compression Level: 15-20mmHg & 20-30mmHgStyle(s): Over the Calf Color(s): White & BlackShoe size, ankle & calf measurementsRetail Price: $30-60

15-20mmHg

20-30mmHg

Cushioned Cotton

Compression Consultation Points for the Diabetic Patient

• Avoid diabetic compression socks upon development of:▫ Severe arterial insufficiency ▫ Intermittent claudication▫ Ischemia▫ Weeping wounds▫ Uncontrolled CHF

• Seek physician consultation and approval to wear diabetic compression socks if neuropathy presents

• Remove socks if they cause persistent pain to lower extremities and pain does not improve with activity

Compression Consultation Points for the Diabetic Patient

• Put on diabetic compression socks daily upon waking & remove at bedtime

• Launder socks every night in a mild washing detergent

• Diabetic compression socks will decrease LE edema & improve circulation to help legs & feet feel better

• Moisturize feet daily before & after sock application with a foot cream to minimize dry, cracked skin

Compression Consultation Points for the Diabetic Patient

•When donning and doffing stockings, it’s best to wear gloves.

•To don, do not bunch the garment like ordinary socks.

•Use the ‘pull-on’ or ‘sock-puppet’ method to don graduated compression garments.

•To doff the garment, pull off like a banana.

Foot Care Consultation Points

• Wash feet daily with luke warm water• Dry feet and between toes well• Keep skin supple with moisturizing

lotion• Use soft socks or stockings, which

must neither be too big or small• Avoid walking bare-foot• Examine shoes daily for

abnormalities/defects• A brisk walk daily stimulates

circulation and makes patient feel better

Palaian S, et al. The Internet Journal of Pharmacology. 2005 Volume 4 Number 1. Available at: http://www.ispub.com/journal/the-internet-journal-of-pharmacology/volume-4-number-1/role-of-pharmacist-in-counseling-diabetes-patients.html. Accessed 05/04/12.

Questions & Discussion

SIGVARIS Graduated Compression Socks …

“It’s Medicine you Wear”

Thank You for Attending!

Kimberly Simmons, PharmD, MBAUS Pharmacy Relations Manager

SIGVARIS Inc.pharmacyrelations@sigvaris.com

770-632-2571 (office)770-632-2973 (fax)